Subset Code	Subset Name	Concept Code	NCIt Preferred Term	NCIt Definition	PQCMC Preferred Term	PQCMC Synonyms(s)	PQCMC Definition
C133807	PQ/CMC Test Category Terminology	C138990	Product Description/Appearance	Tests using visual inspection to assess the physical state and color of the drug substance or product.	Description		An assessment of the physical state (e.g., color, shape, size) of the drug substance or product. [Source: Adapted from ICH Q6A]
C133807	PQ/CMC Test Category Terminology	C138993	Material Identification	Tests that establishes the characteristic and uniqueness  of the substance of interest and should be able to discriminate between compounds of closely related structures which are likely to be present.	Identification		Tests that establishes the characteristic and uniqueness  of the substance of interest and should be able to discriminate between compounds of closely related structures which are likely to be present. [Source: ICH Q6A]
C133807	PQ/CMC Test Category Terminology	C158423	Chemical Impurity	Any unwanted organic, inorganic, and residual solvents in drug substances and final products.	Impurities		Analytical procedures that determine the presence of a component of the material that is not the chemical entity defined as the material.
C133807	PQ/CMC Test Category Terminology	C158425	Biological Property	Characteristics of biological systems.	Biological Properties		Any effect a given material has on a living organism (e.g., microbial limits, endotoxin).
C133807	PQ/CMC Test Category Terminology	C176810	Microbiological Property	The characteristics of, or the effects of a material on a microorganism or microbiome.	Microbiological Properties		The characteristics of, or the effects of a material on a microorganism or microbiome.
C133807	PQ/CMC Test Category Terminology	C176811	Physico-Chemical Properties	The characteristics of a material associated with its composition and basic nature, including but not limited to its texture, smell, freezing point, boiling point, melting point, opacity, viscosity and density.	Physico-Chemical Properties		Assessments of the characteristics of a material that are not associated with a change in its composition and basic nature, including but not limited to its texture, smell, freezing point, boiling point, melting point, opacity, viscosity and density.
C133807	PQ/CMC Test Category Terminology	C60819	Assay	A qualitative or quantitative analysis performed to determine the amount of a particular constituent in a sample or the biological or pharmacological properties of a drug.	Assay		Tests which measure the content of the active ingredient in the drug substance or drug product. Synonymous with strength or purity which is commonly used of define the content of the active ingredient in a drug product. [Source: Adapted from ICH Q6A and Q6B] Note:  chiral purity, preservative content, Anti-Oxidant Concentration, Chelate Concentration, isomeric ratio.
C133846	PQ/CMC Batch Utilization Terminology	C133990	Commercial Batch	A product batch intended for marketing.	Commercial		A product batch intended for marketing.
C133846	PQ/CMC Batch Utilization Terminology	C133991	Development Batch	A batch produced during the characterization and process definition for the desired product.	Development		A batch produced during the characterization and process definition for the desired product.
C133846	PQ/CMC Batch Utilization Terminology	C133992	Clinical Batch	A batch produced for use in clinical trials.	Clinical		A batch produced for use in clinical trials.
C133846	PQ/CMC Batch Utilization Terminology	C133993	Validation Batch	A batch intended for use in verification and demonstration of suitability of the designed process.	Validation		A batch intended for use in verification and demonstration of suitability of the designed process.
C133846	PQ/CMC Batch Utilization Terminology	C133994	Bioequivalence Batch	A batch produced and used for the purposes of determining bioequivalence of the product.	Bioequivalence		A batch produced and used for the purposes of determining bioequivalence of the product.
C133846	PQ/CMC Batch Utilization Terminology	C185328	Stability Study Batch	A batch placed under study to determine the maintained performance parameters over time.	Stability Study		A batch placed under study to determine the maintained performance parameters over time.
C133848	PQ/CMC Chemical Structure Data File Type Terminology	C133910	MDL Molfile Format	A chemical text file format developed by Molecular Design Limited (MDL) that represent information about molecular atoms, bonds, connectivity and coordinates. The file extension is .mol.	MOLFILE		A chemical text file format developed by Molecular Design Limited (MDL) that represent information about molecular atoms, bonds, connectivity and coordinates. The file extension is .mol.
C133848	PQ/CMC Chemical Structure Data File Type Terminology	C133996	MDL Structure-data File Format	A family of chemical text file formats developed by Molecular Design Limited (MDL) that represent multiple chemical structural records and associated data fields. The file extension is .sd or .sdf.	SDF		A family of chemical text file formats developed by Molecular Design Limited (MDL) that represent multiple chemical structural records and associated data fields. The file extension is .sd or .sdf.
C133848	PQ/CMC Chemical Structure Data File Type Terminology	C133997	Macromolecular CIF	A standard text file format for representing crystallographic information of large molecules. The file extension is .mcif.	mmCIF (large molecules)		A standard text file format for representing crystallographic information of large molecules. The file extension is .mcif.
C133848	PQ/CMC Chemical Structure Data File Type Terminology	C49039	Protein Data Bank	A worldwide repository for the processing and distribution of 3-D biological macromolecular structure data.	PDB		A worldwide repository for the processing and distribution of 3-D biological macromolecular structure data.
C133848	PQ/CMC Chemical Structure Data File Type Terminology	C54683	International Chemical Identifier	A textual identifier for chemical substances designed to provide a standard and human-readable way to encode molecular information that also facilitates searches in printed and electronic data sources.	InChI File (small molecule)		A textual identifier for chemical substances designed to provide a standard and human-readable way to encode molecular information that also facilitates searches in printed and electronic data sources.
C133848	PQ/CMC Chemical Structure Data File Type Terminology	C54684	Simplified Molecular Input Line Entry Specification	Specification for unambiguously describing the structure of chemical molecules using short ASCII strings.  SMILES strings can be imported by most molecular editors for conversion back into two-dimensional drawings or three-dimensional models for the molecules.	SMILES		Specification for unambiguously describing the structure of chemical molecules using short ASCII strings.  SMILES strings can be imported by most molecular editors for conversion back into two-dimensional drawings or three-dimensional models for the molecules.
C133849	PQ/CMC Closure Type Terminology	C96113	Child Resistant Metal Container Closure	Metal closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly.	Child-resistant, Metal		Metal closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly.
C133849	PQ/CMC Closure Type Terminology	C96114	Child Resistant Plastic Container Closure	Plastic closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly.	Child-resistant, Plastic		Plastic closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly.
C133849	PQ/CMC Closure Type Terminology	C96115	Continuous Thread Metal Container Closure	Metal closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal.	Continuous Thread, Metal		Metal closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal.
C133849	PQ/CMC Closure Type Terminology	C96116	Continuous Thread Plastic Container Closure	Plastic closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal.	Continuous Thread, Plastic		Plastic closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal.
C133849	PQ/CMC Closure Type Terminology	C96117	Tamper Evident Metal Container Closure	A closure/finish of a closure/container system designed to make it difficult to achieve the first removal of a closure from a container without it being detectable by subsequent users that the package seal has been breached (e.g., aluminum overseal).	Tamper-evident, Metal		A closure/finish of a closure/container system designed to make it difficult to achieve the first removal of a closure from a container without it being detectable by subsequent users that the package seal has been breached (e.g., aluminum overseal).
C133849	PQ/CMC Closure Type Terminology	C96118	Tamper Evident Plastic Container Closure	A closure that shows the package has been opened and the product has been exposed to the outside environment.	Tamper-evident, Plastic		A closure that shows the package has been opened and the product has been exposed to the outside environment.
C133849	PQ/CMC Closure Type Terminology	C96119	Vacuum Sealed Metal Container Closure	Metal closures used on packages where the pressure inside the package is less than atmospheric.	Vacuum, Metal		Metal closures used on packages where the pressure inside the package is less than atmospheric.
C133849	PQ/CMC Closure Type Terminology	C96120	Tamper Evident Composite Container Closure	Composite tamper-evident closures usually consist of a metal disk with a plastic skirt. The plastic skirt is perforated or weakened in some manner so that when the closure is removed, this section is designed to break and either remain on the container or attached to the closure to indicate the package has been opened.	Tamper-evident, Composite		Composite tamper-evident closures usually consist of a metal disk with a plastic skirt. The plastic skirt is perforated or weakened in some manner so that when the closure is removed, this section is designed to break and either remain on the container or attached to the closure to indicate the package has been opened.
C133849	PQ/CMC Closure Type Terminology	C96121	Vacuum Sealed Plastic Container Closure	Plastic closures used on packages where the pressure inside the package is less than atmospheric.	Vacuum, Plastic		Plastic closures used on packages where the pressure inside the package is less than atmospheric.
C133849	PQ/CMC Closure Type Terminology	C96122	Vacuum Sealed Composite Container Closure	Metal/Plastic closures used on packages where the pressure inside the package is less than atmospheric.	Vacuum, Composite		Metal/Plastic closures used on packages where the pressure inside the package is less than atmospheric.
C133849	PQ/CMC Closure Type Terminology	C96123	Press-On/Twist-Off Metal Container Closure	Closure with a stepped, skirted drawn shell with an inside curl. The closure is lined with an annular plastisol material designed to provide a proper seal along the top and side surfaces of the glass container finish. The closure uses a special plastisol material that, following application, takes a permanent impression of the glass threads ensuring cam-off and reseal.	Press-on/twist-off, Metal		Closure with a stepped, skirted drawn shell with an inside curl. The closure is lined with an annular plastisol material designed to provide a proper seal along the top and side surfaces of the glass container finish. The closure uses a special plastisol material that, following application, takes a permanent impression of the glass threads ensuring cam-off and reseal.
C133849	PQ/CMC Closure Type Terminology	C96124	Press-On Composite Container Closure	A metal/plastic composite cap composed of a plastisol lined metal disk, assembled to a plastic band. The closure requires a simple glass bead finish common on bowls, tumblers and carafes.	Press-on, Composite		A metal/plastic composite cap composed of a plastisol lined metal disk, assembled to a plastic band. The closure requires a simple glass bead finish common on bowls, tumblers and carafes.
C133849	PQ/CMC Closure Type Terminology	C96125	Crown Metal Container Closure	A non-threaded shallow draw metal closure that normally has 21 corrugations on the outer edge, which function to engage the container when applied. The crown is only 1/4" high when manufactured and does not have a rolled edge or wire. The crown is manufactured 26mm worldwide and can be applied to either a threaded finish or a solid ring pry-off finish.	Crown, Metal		A non-threaded shallow draw metal closure that normally has 21 corrugations on the outer edge, which function to engage the container when applied. The crown is only 1/4\ high when manufactured and does not have a rolled edge or wire. The crown is manufactured 26mm worldwide and can be applied to either a threaded finish or a solid ring pry-off finish.
C133849	PQ/CMC Closure Type Terminology	C96126	Lug Metal Container Closure	Closure with an ability to be applied and removed with a partial turn. The closure can also be produced with vacuum buttons that can clearly indicate to the packer if a vacuum has been effectively drawn following the closure application.	Lug, Metal		Closure with an ability to be applied and removed with a partial turn. The closure can also be produced with vacuum buttons that can clearly indicate to the packer if a vacuum has been effectively drawn following the closure application.
C133849	PQ/CMC Closure Type Terminology	C96127	Roll On Metal Container Closure	A tamper-evident closure produced as an unthreaded shell containing a liner. It is applied to the proper finish on a plastic or glass container by the bottler, using a roll-on capping machine that forms a thread in the closure matching the bottle thread.	Roll-on, Metal		A tamper-evident closure produced as an unthreaded shell containing a liner. It is applied to the proper finish on a plastic or glass container by the bottler, using a roll-on capping machine that forms a thread in the closure matching the bottle thread.
C133849	PQ/CMC Closure Type Terminology	C96128	Flip-Top Dispensing Plastic Container Closure	A hinged single or dual flap closure for controlled product dispensing.	Flip-Top (Dispensing), Plastic		A hinged single or dual flap closure for controlled product dispensing.
C133849	PQ/CMC Closure Type Terminology	C96129	Hinged Dispensing Plastic Container Closure	A closure with a lid that is hinged to the top of a closure and opens to expose a dispensing orifice.	Hinged (Dispensing), Plastic		A closure with a lid that is hinged to the top of a closure and opens to expose a dispensing orifice.
C133849	PQ/CMC Closure Type Terminology	C96130	Linerless Plastic Container Closure	A closure that incorporates a specific molded-in feature such as rings, plugs or flexible sections. These features achieve a seal by conforming to one or more of the sealing surfaces on the container neck finish.	Linerless, Plastic		A closure that incorporates a specific molded-in feature such as rings, plugs or flexible sections. These features achieve a seal by conforming to one or more of the sealing surfaces on the container neck finish.
C133849	PQ/CMC Closure Type Terminology	C96131	Pump Dispensing Plastic Container Closure	Closure dispensing pumps are used to dispense product from containers.	Pump (Dispensing), Plastic		Closure dispensing pumps are used to dispense product from containers.
C133849	PQ/CMC Closure Type Terminology	C96132	Push-Pull Dispensing Plastic Container Closure	A two-piece dispensing closure that includes a base member the lower portion of which is designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. The spout member may be moved upward and downward to open and close the dispensing passageway.	Push-pull (Dispensing), Plastic		A two-piece dispensing closure that includes a base member the lower portion of which is designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. The spout member may be moved upward and downward to open and close the dispensing passageway.
C133849	PQ/CMC Closure Type Terminology	C96133	Snap-On Cap Plastic Container Closure	A non-threaded closure that is pressed onto the package finish with a protruding feature that mates with a similar protruding feature on the closure to secure the closure to the package.	Snap-on Cap, Plastic		A non-threaded closure that is pressed onto the package finish with a protruding feature that mates with a similar protruding feature on the closure to secure the closure to the package.
C133849	PQ/CMC Closure Type Terminology	C96134	Snip-Tip Dispensing Plastic Container Closure	Conical closure that is turned onto a container. The tip is cut off to open the container.	Snip-tip (Dispensing), Plastic		Conical closure that is turned onto a container. The tip is cut off to open the container.
C133849	PQ/CMC Closure Type Terminology	C96135	Toggle-Swing Dispensing Plastic Container Closure	A closure with a lower part attaches securely and seals the container. The upper part provides a second movable portion which functions in a rocker-like pivotal motion between an open and a closed position.	Toggle-swing (Dispensing), Plastic		A closure with a lower part attaches securely and seals the container. The upper part provides a second movable portion which functions in a rocker-like pivotal motion between an open and a closed position.
C133849	PQ/CMC Closure Type Terminology	C96136	Trigger Spray Dispensing Plastic Container Closure	Closure designed to dispense product from containers by spraying the product when a trigger is pulled.	Trigger Sprayer (Dispensing), Plastic		Closure designed to dispense product from containers by spraying the product when a trigger is pulled.
C133849	PQ/CMC Closure Type Terminology	C96137	Twist Open/Close Dispensing Plastic Container Closure	Two-piece dispensing closure that has a lower portion designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. Rotating the spout member opens and closed the container.	Twist Open/Close (Dispensing), Plastic		Two-piece dispensing closure that has a lower portion designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. Rotating the spout member opens and closed the container.
C133849	PQ/CMC Closure Type Terminology	C96138	Valved Dispensing Plastic Container Closure	Dispensing closure incorporating a product-flow controlling valve within the orifice. Product will not dispense from the package until sufficient squeezing pressure is applied to the flexible container to cause the valve to open.	Valved (Dispensing), Plastic		Dispensing closure incorporating a product-flow controlling valve within the orifice. Product will not dispense from the package until sufficient squeezing pressure is applied to the flexible container to cause the valve to open.
C133849	PQ/CMC Closure Type Terminology	C96139	Stopper Container Closure	Object used to plug opening of container.	Stopper		Object used to plug opening of container.
C133849	PQ/CMC Closure Type Terminology	C96140	Tie Container Closure	Line, ribbon, or cord used for fastening, or drawing the container closed.	Tie		Line, ribbon, or cord used for fastening, or drawing the container closed.
C133851	PQ/CMC Conformance to Criteria Terminology	C133998	Does Not Conform	An observation that the item of interest does not match required specifications.	Does not conform		An observation that the item of interest does not match required specifications.
C133851	PQ/CMC Conformance to Criteria Terminology	C80262	Conformance	Correspondence in form or appearance.	Conforms		Correspondence in form or appearance.
C133852	PQ/CMC Container Orientation Terminology	C133914	Valve-up	A position in which the valve indicator is pointing up.	Valve-up		A position in which the valve indicator is pointing up.
C133852	PQ/CMC Container Orientation Terminology	C133915	Valve-down	A position in which the valve indicator is pointing down.	Valve-down		A position in which the valve indicator is pointing down.
C133852	PQ/CMC Container Orientation Terminology	C133999	Inverted	To place upside down.	Inverted		To place upside down.
C133852	PQ/CMC Container Orientation Terminology	C25241	Horizontal	Parallel to or in the plane of the horizon.	Horizontal		Parallel to or in the plane of the horizon.
C133852	PQ/CMC Container Orientation Terminology	C86043	Upright	In a vertical position or posture.	Upright		In a vertical position or posture.
C133853	PQ/CMC Container Type Terminology	C16738	Inhaler	A device by means of which a medicinal product can be administered by inspiration through the nose or the mouth.	INHALER		A device by means of which a medicinal product can be administered by inspiration through the nose or the mouth.
C133853	PQ/CMC Container Type Terminology	C42794	Packaging Tube	A flexible container for semisolid drug products which is flattened and crimped or sealed at one end and has a reclosable opening at the other.	TUBE		A flexible container for semisolid drug products which is flattened and crimped or sealed at one end and has a reclosable opening at the other.
C133853	PQ/CMC Container Type Terminology	C43165	Ampule	A container capable of being hermetically sealed, intended to hold sterile materials.	AMPULE		A container capable of being hermetically sealed, intended to hold sterile materials.
C133853	PQ/CMC Container Type Terminology	C43166	Applicator	A pre-filled non-injectable pipette, syringe or tube.	APPLICATOR		A pre-filled non-injectable pipette, syringe or tube.
C133853	PQ/CMC Container Type Terminology	C43167	Bag	A sac or pouch.	BAG		A sac or pouch.
C133853	PQ/CMC Container Type Terminology	C43168	Blister Pack	A package that consists of molded plastic or laminate that has indentations (viewed as 'blisters' when flipped) into which a dosage form, is placed. A covering, usually of laminated material, is then sealed to the molded part. A strip pack is a specialized type of blister pack where there are no pre-formed or molded parts; in this case there are two flexible layers that are sealed with the dosage form in between. Suppositories that are strip packed between two layers of foil are also considered a blister pack.	BLISTER PACK		A package that consists of molded plastic or laminate that has indentations (viewed as 'blisters' when flipped) into which a dosage form, is placed. A covering, usually of laminated material, is then sealed to the molded part. A strip pack is a specialized type of blister pack where there are no pre-formed or molded parts; in this case there are two flexible layers that are sealed with the dosage form in between. Suppositories that are strip packed between two layers of foil are also considered a blister pack.
C133853	PQ/CMC Container Type Terminology	C43169	Bottle	A vessel with a narrow neck designed to accept a specific closure.	BOTTLE		A vessel with a narrow neck designed to accept a specific closure.
C133853	PQ/CMC Container Type Terminology	C43170	Dispensing Bottle	A bottle that is used by the pharmacist to dispense the prescribed medication. It includes preparations for which a dropper accompanies the bottle.	BOTTLE, DISPENSING		A bottle that is used by the pharmacist to dispense the prescribed medication. It includes preparations for which a dropper accompanies the bottle.
C133853	PQ/CMC Container Type Terminology	C43171	Dropper Bottle	A bottle that has a device specifically intended for the application of a liquid in a drop by drop manner, or a device intended for the delivery of an exact dose (e.g., calibrated dropper for oral medications).	BOTTLE, DROPPER		A bottle that has a device specifically intended for the application of a liquid in a drop by drop manner, or a device intended for the delivery of an exact dose (e.g., calibrated dropper for oral medications).
C133853	PQ/CMC Container Type Terminology	C43172	Glass Bottle	A glass vessel with a narrow neck designed to accept a specific closure.	BOTTLE, GLASS		A glass vessel with a narrow neck designed to accept a specific closure.
C133853	PQ/CMC Container Type Terminology	C43173	Plastic Bottle	A plastic vessel with a narrow neck designed to accept a specific closure.	BOTTLE, PLASTIC		A plastic vessel with a narrow neck designed to accept a specific closure.
C133853	PQ/CMC Container Type Terminology	C43174	Pump Bottle	A bottle that is fitted with a pumping mechanism for the administration of drug product.	BOTTLE, PUMP		A bottle that is fitted with a pumping mechanism for the administration of drug product.
C133853	PQ/CMC Container Type Terminology	C43175	Spray Bottle	A bottle that is fitted with an atomizer or a device which produces finely divided liquid carried by air.	BOTTLE, SPRAY		A bottle that is fitted with an atomizer or a device which produces finely divided liquid carried by air.
C133853	PQ/CMC Container Type Terminology	C43176	Unit Dose Bottle	A bottle that contains a single whole dose of a non-parenteral drug product.	BOTTLE, UNIT-DOSE		A bottle that contains a single whole dose of a non-parenteral drug product.
C133853	PQ/CMC Container Type Terminology	C43177	Applicator Bottle	A bottle which includes a device for applying its contents.	BOTTLE, WITH APPLICATOR		A bottle which includes a device for applying its contents.
C133853	PQ/CMC Container Type Terminology	C43178	Box	A square or rectangular vessel, usually made of cardboard or plastic.	BOX		A square or rectangular vessel, usually made of cardboard or plastic.
C133853	PQ/CMC Container Type Terminology	C43179	Unit Dose Box	A box that contains a single dose of a non-parenteral drug product. [Note: Boxes that contain 100 unit dose blister packs should be classified under blister pack, since this is the immediate container into which the dosage form is placed.]	BOX, UNIT-DOSE		A box that contains a single dose of a non-parenteral drug product. [Note: Boxes that contain 100 unit dose blister packs should be classified under blister pack, since this is the immediate container into which the dosage form is placed.]
C133853	PQ/CMC Container Type Terminology	C43180	Can	A cylindrical vessel, usually made of metal.	CAN		A cylindrical vessel, usually made of metal.
C133853	PQ/CMC Container Type Terminology	C43181	Canister	A type of can for holding a drug product.	CANISTER		A type of can for holding a drug product.
C133853	PQ/CMC Container Type Terminology	C43182	Carton	A cardboard box or container which is usually considered a secondary packaging component.	CARTON		A cardboard box or container which is usually considered a secondary packaging component.
C133853	PQ/CMC Container Type Terminology	C43183	Cartridge	A container consisting of a cylinder with a septum at one end, and a seal at the other end, which is inserted into a device to form a syringe which contains a single dose of a parenteral drug product.	CARTRIDGE		A container consisting of a cylinder with a septum at one end, and a seal at the other end, which is inserted into a device to form a syringe which contains a single dose of a parenteral drug product.
C133853	PQ/CMC Container Type Terminology	C43184	Packaging Case	A receptacle for holding something (e.g., that into which some oral contraceptive blister packs are placed).	CASE		A receptacle for holding something (e.g., that into which some oral contraceptive blister packs are placed).
C133853	PQ/CMC Container Type Terminology	C43185	Cello Pack	A plastic 'clamshell' [thin plastic pre-formed structure for a device].	CELLO PACK		A plastic 'clamshell' [thin plastic pre-formed structure for a device].
C133853	PQ/CMC Container Type Terminology	C43186	Container	An object that can be used to hold things.	CONTAINER		An object that can be used to hold things.
C133853	PQ/CMC Container Type Terminology	C43187	Cup	A bowl-shaped container.	CUP		A bowl-shaped container.
C133853	PQ/CMC Container Type Terminology	C43188	Unit Dose Cup	A cup intended to hold a single dose of a non-parenteral drug product.	CUP, UNIT-DOSE		A cup intended to hold a single dose of a non-parenteral drug product.
C133853	PQ/CMC Container Type Terminology	C43189	Gas Cylinder	A container designed specifically to hold gases.	CYLINDER		A container designed specifically to hold gases.
C133853	PQ/CMC Container Type Terminology	C43190	Dewar	A container, usually made of glass or metal, that has at least two walls with the space between each wall evacuated so as to prevent the transfer of heat. The inside of the container often has a coating (as silvering) on the inside to reduce heat transfer, and is used especially for storing liquefied gases or for experiments at low temperatures. The size can vary from that of a small thermos bottle up to that which may be mounted upon a large truck (also known as a 'cryogenic truck').	DEWAR		A container, usually made of glass or metal, that has at least two walls with the space between each wall evacuated so as to prevent the transfer of heat. The inside of the container often has a coating (as silvering) on the inside to reduce heat transfer, and is used especially for storing liquefied gases or for experiments at low temperatures. The size can vary from that of a small thermos bottle up to that which may be mounted upon a large truck (also known as a 'cryogenic truck').
C133853	PQ/CMC Container Type Terminology	C43191	Dialpack	A dose pack container designed to assist with patient compliance. The patient turns a dial to the correct day and the correct dose is made available and the container indicates that the dose has been removed.	DIALPACK		A dose pack container designed to assist with patient compliance. The patient turns a dial to the correct day and the correct dose is made available and the container indicates that the dose has been removed.
C133853	PQ/CMC Container Type Terminology	C43192	Dose Pack	A container in which a preselected dose or dose regimen of the medication is placed.	DOSE PACK		A container in which a preselected dose or dose regimen of the medication is placed.
C133853	PQ/CMC Container Type Terminology	C43193	Packaging Drum	A straight-sided cylindrical shipping container with flat ends; one of which can be opened/closed.	DRUM		A straight-sided cylindrical shipping container with flat ends; one of which can be opened/closed.
C133853	PQ/CMC Container Type Terminology	C43194	Inhaler Refill	A container of medication intended to refill an inhaler.	INHALER, REFILL		A container of medication intended to refill an inhaler.
C133853	PQ/CMC Container Type Terminology	C43195	Jar	A rigid container having a wide mouth and often no neck which typically holds solid or semisolid drug products.	JAR		A rigid container having a wide mouth and often no neck which typically holds solid or semisolid drug products.
C133853	PQ/CMC Container Type Terminology	C43196	Jug	A large, deep container that has a narrow mouth, is typically fitted with a handle, and is used to hold liquids.	JUG		A large, deep container that has a narrow mouth, is typically fitted with a handle, and is used to hold liquids.
C133853	PQ/CMC Container Type Terminology	C43197	Drug Kit	A packaged set of related pharmaceutical or and/or drug delivery devices used for a particular medical activity or procedure including required documentation for kit components and the entire kit.	KIT		A packaged set of related pharmaceutical or and/or drug delivery devices used for a particular medical activity or procedure including required documentation for kit components and the entire kit.
C133853	PQ/CMC Container Type Terminology	C43198	Combination Package	A package in which two or more drug products that are normally available separately are now available together.	PACKAGE, COMBINATION		A package in which two or more drug products that are normally available separately are now available together.
C133853	PQ/CMC Container Type Terminology	C43199	Packet	An envelope into which only one dose of a drug product, usually in the form of granules or powder, has been directly placed. An example includes glassine powder paper containing aspirin. Other examples include aluminum foil packets into which alcohol swabs and pledgets are placed.	PACKET		An envelope into which only one dose of a drug product, usually in the form of granules or powder, has been directly placed. An example includes glassine powder paper containing aspirin. Other examples include aluminum foil packets into which alcohol swabs and pledgets are placed.
C133853	PQ/CMC Container Type Terminology	C43200	Pouch	A flexible container used to protect or hold one or more doses of a drug product (e.g. a pouch into which oral contraceptive blister packs are inserted, and an overwrap pouch for large volume parenterals).	POUCH		A flexible container used to protect or hold one or more doses of a drug product (e.g. a pouch into which oral contraceptive blister packs are inserted, and an overwrap pouch for large volume parenterals).
C133853	PQ/CMC Container Type Terminology	C43201	Supersack	A multilayer paper bag for shipping some solid bulk excipients, usually in the form of powder or granules.	SUPERSACK		A multilayer paper bag for shipping some solid bulk excipients, usually in the form of powder or granules.
C133853	PQ/CMC Container Type Terminology	C43202	Syringe	A device for the administration of drug products that consists of a rigid barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate.	SYRINGE		A device for the administration of drug products that consists of a rigid barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate.
C133853	PQ/CMC Container Type Terminology	C43203	Glass Syringe	A device for the administration of parenteral drug products that consists of a rigid glass barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate.	SYRINGE, GLASS		A device for the administration of parenteral drug products that consists of a rigid glass barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate.
C133853	PQ/CMC Container Type Terminology	C43204	Plastic Syringe	A device for the administration of parenteral drug products that consists of a rigid plastic barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate.	SYRINGE, PLASTIC		A device for the administration of parenteral drug products that consists of a rigid plastic barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate.
C133853	PQ/CMC Container Type Terminology	C43205	Tabminder	A specialized package; it registers each time it is opened and is used for checking patient compliance to prescribed medication regimens.	TABMINDER		A specialized package; it registers each time it is opened and is used for checking patient compliance to prescribed medication regimens.
C133853	PQ/CMC Container Type Terminology	C43206	Packaging Tank	A large receptacle used for holding, transporting, or storing liquids or gases, and often referred to as a reservoir.	TANK		A large receptacle used for holding, transporting, or storing liquids or gases, and often referred to as a reservoir.
C133853	PQ/CMC Container Type Terminology	C43207	Applicator Tube	A tube which is provided with a device (the applicator) for administering the dosage form. The applicator may be part of the tube closure or be separate.	TUBE, WITH APPLICATOR		A tube which is provided with a device (the applicator) for administering the dosage form. The applicator may be part of the tube closure or be separate.
C133853	PQ/CMC Container Type Terminology	C43208	Dispensing Vial	A vial that is used by the pharmacist to dispense the prescribed medication.	VIAL, DISPENSING		A vial that is used by the pharmacist to dispense the prescribed medication.
C133853	PQ/CMC Container Type Terminology	C43209	Glass Vial	A glass container designed for use with parenteral drug products.	VIAL, GLASS		A glass container designed for use with parenteral drug products.
C133853	PQ/CMC Container Type Terminology	C43210	Multi Dose Vial	A vial intended to contain more than one dose of the drug product.	VIAL, MULTI-DOSE		A vial intended to contain more than one dose of the drug product.
C133853	PQ/CMC Container Type Terminology	C43211	Patent Delivery System Vial	A vial that has a patented delivery system.	VIAL, PATENT DELIVERY SYSTEM		A vial that has a patented delivery system.
C133853	PQ/CMC Container Type Terminology	C43212	Pharmacy Bulk Vial	A container of a sterile preparation whose contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion or, through a sterile transfer device, for the filling of empty sterile syringes.	VIAL, PHARMACY BULK PACKAGE		A container of a sterile preparation whose contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion or, through a sterile transfer device, for the filling of empty sterile syringes.
C133853	PQ/CMC Container Type Terminology	C43213	Piggyback Vial	A vial that contains a parenteral preparation that can be attached directly to the tubing of a parenterally administered fluid.	VIAL, PIGGYBACK		A vial that contains a parenteral preparation that can be attached directly to the tubing of a parenterally administered fluid.
C133853	PQ/CMC Container Type Terminology	C43214	Plastic Vial	A plastic container designed for use with parenteral drug products.	VIAL, PLASTIC		A plastic container designed for use with parenteral drug products.
C133853	PQ/CMC Container Type Terminology	C43215	Single Dose Vial	A vial containing a single unit of a parenteral drug product.	VIAL, SINGLE-DOSE		A vial containing a single unit of a parenteral drug product.
C133853	PQ/CMC Container Type Terminology	C43216	Single Use Vial	A vial where a single dose of a parenteral drug product can be removed, and then the vial and its remaining contents can be disposed.	VIAL, SINGLE-USE		A vial where a single dose of a parenteral drug product can be removed, and then the vial and its remaining contents can be disposed.
C133853	PQ/CMC Container Type Terminology	C43226	Parenteral Vial	A container designed for use with parenteral drug products.	VIAL		A container designed for use with parenteral drug products.
C133853	PQ/CMC Container Type Terminology	C43233	Drug Package	The drug product container with any accompanying materials or components. This may include the protective packaging, labeling, administration devices, etc.	PACKAGE		The drug product container with any accompanying materials or components. This may include the protective packaging, labeling, administration devices, etc.
C133853	PQ/CMC Container Type Terminology	C48626	Package Type Not Stated	The package type is not stated or is unavailable.	NOT STATED		The package type is not stated or is unavailable.
C133853	PQ/CMC Container Type Terminology	C53438	Tray	A shallow flat receptacle, with a raised edge or rim, used for carrying, holding, or displaying finished drug product in its primary or market package. A tray and its contents may be encased in shrink-wrapped plastic for shipping, or with a cover or an overwrap as part of a unit of use package or kit.	TRAY		A shallow flat receptacle, with a raised edge or rim, used for carrying, holding, or displaying finished drug product in its primary or market package. A tray and its contents may be encased in shrink-wrapped plastic for shipping, or with a cover or an overwrap as part of a unit of use package or kit.
C133853	PQ/CMC Container Type Terminology	C79135	Flexible Intermediate Bulk Container	A receptacle with a body constructed of film, woven plastic, woven fabric, paper or combination thereof, together with any appropriate service equipment and handling devices, and if necessary, an inner coating or liner.	FLEXIBLE INTERMEDIATE BULK CONTAINER		A receptacle with a body constructed of film, woven plastic, woven fabric, paper or combination thereof, together with any appropriate service equipment and handling devices, and if necessary, an inner coating or liner.
C133853	PQ/CMC Container Type Terminology	C79136	Pail	A watertight vessel, often cylindrical, that is usually fitted with a handle, and that may have a lid.	PAIL		A watertight vessel, often cylindrical, that is usually fitted with a handle, and that may have a lid.
C133853	PQ/CMC Container Type Terminology	C82332	Patch	A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body.	PATCH		A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body.
C133853	PQ/CMC Container Type Terminology	C92708	Capsule	A drug packaging type usually in a cylindrical shape with rounded ends. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid drug products.	CAPSULE		A drug packaging type usually in a cylindrical shape with rounded ends. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid drug products.
C133853	PQ/CMC Container Type Terminology	C96141	Petri Dish	A shallow dish with a lid used to culture cells.	Dish, Petri		A shallow dish with a lid used to culture cells.
C133853	PQ/CMC Container Type Terminology	C96142	Microwell Plate	A flat dish type device with multiple wells for testing cellular material.	Plate, Microwell		A flat dish type device with multiple wells for testing cellular material.
C133853	PQ/CMC Container Type Terminology	C96143	Lined Canister	A round container that has an inner layer of a material different from what the canister is composed of.	Canisters, lined		A round container that has an inner layer of a material different from what the canister is composed of.
C133853	PQ/CMC Container Type Terminology	C96144	Flask	A container with a base wider than the narrow neck traditionally used for holding liquids.	Flask		A container with a base wider than the narrow neck traditionally used for holding liquids.
C133856	PQ/CMC Impurity Classification Terminology	C134001	Inorganic Impurity	Any unwanted inorganic compound generated during the manufacturing process of a particular substance or product.	Inorganic		Materials that are not carbon-based and are generated during a manufacturing process that are not part of elemental impurity specification.
C133856	PQ/CMC Impurity Classification Terminology	C176812	Process Related Impurity	Impurities that are derived from the manufacturing process. They may be derived from cell substrates (e.g., host cell proteins, host cell DNA), cell culture (e.g., inducers, antibiotics, or media components), or downstream processing (e.g., processing reagents or column leachables), or starting materials.	Process Related/Process		Impurities that are derived from the manufacturing process. [Source: SME Defined] Examples: Small molecules -- starting materials, intermediates, antibiotics, or media components, by-products, etc. Large molecules -- They may be derived from cell substrates (e.g., host cell proteins, host cell DNA), cell culture (e.g., inducers, antibiotics, or media components), or downstream processing  (e.g., processing reagents or resin leachables).
C133856	PQ/CMC Impurity Classification Terminology	C176813	Product Related Impurity	Molecular variants of the desired product (e.g., precursors, certain degradation products arising during manufacture and/or storage) which do not have properties comparable to those of the desired product with respect to activity, efficacy, and safety.	Product Related		Molecular variants of the desired product (e.g., precursors, certain degradation products arising during manufacture and/or storage) which do not have properties comparable to those of the desired product with respect to activity, efficacy, and safety. [Source: ICH Q6B]
C133856	PQ/CMC Impurity Classification Terminology	C176815	Residual Solvent	Inorganic or organic liquids added during the manufacturing process.	Residual Solvent		Inorganic or organic liquids added during the manufacturing process. [Source: Adapted from ICH Q3A(R2)]
C133856	PQ/CMC Impurity Classification Terminology	C176816	Degradant	An impurity resulting from a chemical change in the drug substance.	Degradation Product		A molecule resulting from a chemical change brought about over time and/or by the action of something (e.g., light, temperature, pH, water, or by reaction with an excipient and/or the immediate container/closure system). [Source: SME Defined]
C133856	PQ/CMC Impurity Classification Terminology	C185190	Elemental Impurity	Elements that are found in the environment or that are used or introduced in the manufacture of drug substances or excipients.	Elemental Impurities		Elements that are found in the environment or that are used or introduced in the manufacture of drug substances or excipients. [Source: Elemental Impurities - Information, USP Pharmacopeial Forum, Vol. 36(1)]
C133856	PQ/CMC Impurity Classification Terminology	C185192	Leachable Material	Materials that can migrate from manufacturing systems, container-closure systems and drug-delivery components.	Leachables		Materials that can migrate from manufacturing systems, container-closure systems and drug-delivery components. [Source: Adapted from  ICH Q3E Concept Paper]
C133856	PQ/CMC Impurity Classification Terminology	C92081	Microbial Contamination	The undesirable presence of microorganisms or microbes such as bacteria and fungi (yeasts and molds).	Microbiological		Microorganism contamination of the cell culture or starting/raw materials that are objectionable due to their detrimental effect on products or potential harm to patients or due to the total number of organisms. [Source: 21CFR211 Preamble]. Examples: bacteria, fungi, mollicutes (mycoplasmas or spiroplasmas), mycobacteria, rickettsia, protozoa, parasites, agents causing TSEs and viruses.
C133858	PQ/CMC Interpretation Code (numeric) Terminology	C48660	Not Applicable	Determination of a value is not relevant in the current context.	Not Applicable	NA	Determination of a value is not relevant in the current context.
C133858	PQ/CMC Interpretation Code (numeric) Terminology	C48793	Equivalent	A person or thing equal to another in value or measure or force or effect or significance etc.; being essentially equal to something.	EQ		
C133858	PQ/CMC Interpretation Code (numeric) Terminology	C61583	Greater Than or Equal To	A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest exceeds the other object in one of these ways.	NLT (not less than)		A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest exceeds the other object in one of these ways.
C133858	PQ/CMC Interpretation Code (numeric) Terminology	C61584	Greater Than	A statement about the relative size or order of two objects specifying that an object of interest exceeds another object in quantity or measure or value or status.	MT (more than)		A statement about the relative size or order of two objects specifying that an object of interest exceeds another object in quantity or measure or value or status.
C133858	PQ/CMC Interpretation Code (numeric) Terminology	C61585	Less Than	A statement about the relative size or order of two objects specifying that an object of interest is smaller than another object in quantity or measure or value or status.	LT (less than)		A statement about the relative size or order of two objects specifying that an object of interest is smaller than another object in quantity or measure or value or status.
C133858	PQ/CMC Interpretation Code (numeric) Terminology	C61586	Less Than or Equal To	A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest is smaller than the other object in one of these ways.	NMT (not more than)		A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest is smaller than the other object in one of these ways.
C133860	PQ/CMC Quality Benchmark Terminology	C134006	United States Pharmacopeia-National Formulary	An official publication managed and maintained by the US Pharamacopeial Convention, that gives the composition, description, method of preparation, and dosage for drugs.	USP-NF		An official publication managed and maintained by the US Pharamacopeial Convention, that gives the composition, description, method of preparation, and dosage for drugs.
C133860	PQ/CMC Quality Benchmark Terminology	C134007	European Pharmacopeia	A European reference publication from that is a legal and scientific benchmark for pharmacopoeial standards.	EP		A European reference publication from that is a legal and scientific benchmark for pharmacopoeial standards.
C133860	PQ/CMC Quality Benchmark Terminology	C134008	Japanese Pharmacopeia	A reference publication considered the official pharmacopoeia of Japan that is published under the authority of the Ministry of Health, Labour and Welfare.	JP		A reference publication considered the official pharmacopoeia of Japan that is published under the authority of the Ministry of Health, Labour and Welfare.
C133860	PQ/CMC Quality Benchmark Terminology	C134009	Company Standard	A trademarked, copyrighted standard belonging to an organization.	Company Standard		A trademarked, copyrighted standard belonging to an organization.
C133860	PQ/CMC Quality Benchmark Terminology	C176793	British Pharmacopeia	A British reference publication from that is a legal and scientific benchmark for pharmacopoeial standards.	BP		A British reference publication from that is a legal and scientific benchmark for pharmacopoeial standards.
C133862	PQ/CMC Source Type Terminology	C14182	Animal	A living organism that has membranous cell walls, requires oxygen and organic foods, and is capable of voluntary movement, as distinguished from a plant or mineral.	Animal		A living organism that has membranous cell walls, requires oxygen and organic foods, and is capable of voluntary movement, as distinguished from a plant or mineral.
C133862	PQ/CMC Source Type Terminology	C14225	Human	The bipedal primate mammal, Homo sapiens; belonging to man or mankind; pertaining to man or to the race of man; use of man as experimental subject or unit of analysis in research.	Human		The bipedal primate mammal, Homo sapiens; belonging to man or mankind; pertaining to man or to the race of man; use of man as experimental subject or unit of analysis in research.
C133862	PQ/CMC Source Type Terminology	C14227	Insect	A taxonomic class of arthropods that includes praying mantises, dragonflies, grasshoppers, true bugs, flies, bees, wasps, ants, butterflies, moths, and beetles.	Insect		A taxonomic class of arthropods that includes praying mantises, dragonflies, grasshoppers, true bugs, flies, bees, wasps, ants, butterflies, moths, and beetles.
C133862	PQ/CMC Source Type Terminology	C14258	Plant	Any living organism that typically synthesizes its food from inorganic substances, possesses cellulose cell walls, responds slowly and often permanently to a stimulus, lacks specialized sense organs and nervous system, and has no powers of locomotion. (EPA Terminology Reference System)	Plant		Any living organism that typically synthesizes its food from inorganic substances, possesses cellulose cell walls, responds slowly and often permanently to a stimulus, lacks specialized sense organs and nervous system, and has no powers of locomotion. (EPA Terminology Reference System)
C133862	PQ/CMC Source Type Terminology	C14329	Microorganism	A microscopic organism. The term microorganism may refer to a prokaryote or eukaryote, and may be a unicellular or multicellular organism. All taxonomic kingdoms contain microorganisms.	Microbial		A microscopic organism. The term microorganism may refer to a prokaryote or eukaryote, and may be a unicellular or multicellular organism. All taxonomic kingdoms contain microorganisms.
C133862	PQ/CMC Source Type Terminology	C18634	Animal Sources	Indicates that a product is derived from an animal.	Animal-derived indirectly		Indicates that a product is derived from an animal.
C133862	PQ/CMC Source Type Terminology	C48807	Chemical	A substance with a defined atomic or molecular structure that results from, or takes part in, reactions involving changes in its structure, composition, or properties.	Chemical		A substance with a defined atomic or molecular structure that results from, or takes part in, reactions involving changes in its structure, composition, or properties.
C133863	PQ/CMC Specification Status Terminology	C134010	Tentative Approval	Provisional approval of a specification.	Tentatively Approved		Provisional approval of a specification.
C133863	PQ/CMC Specification Status Terminology	C134011	Not Approved	A specification that has not yet been approved.	Not Approved		A specification that has not yet been approved.
C133863	PQ/CMC Specification Status Terminology	C134012	Reported in a CBE or AR	The specification may be used without prior approval, and was submitted in a changes being effected (CBE) supplement or an annual report (AR).	Reported in a CBE or AR		The specification may be used without prior approval, and was submitted in a changes being effected (CBE) supplement or an annual report (AR).
C133863	PQ/CMC Specification Status Terminology	C25425	Approval	Acceptance as satisfactory by an authoritative body; established by authority; given authoritative approval.	Approved		Acceptance as satisfactory by an authoritative body; established by authority; given authoritative approval.
C133863	PQ/CMC Specification Status Terminology	C48660	Not Applicable	Determination of a value is not relevant in the current context.	Not Applicable	NA	Determination of a value is not relevant in the current context.
C133864	PQ/CMC Specification Type Terminology	C133931	Raw Materials/Excipients/Intermediates/Reagents Specification	The specification which is applied to the raw materials, excipients, intermediates or reagents.	Raw Materials/Excipients/Intermediates/Reagents		The specification which is applied to the raw materials, excipients, intermediates or reagents.
C133864	PQ/CMC Specification Type Terminology	C134021	Drug Product Specification	The specification which is applied to the drug product.	Drug Product		The specification which is applied to the drug product.
C133864	PQ/CMC Specification Type Terminology	C134022	Drug Substance Specification	The specification which is applied to the drug substance.	Drug Substance		The specification which is applied to the drug substance.
C133865	PQ/CMC Storage Conditions Terminology	C133935	Temperature 5 (+/-) 3 Degrees C	Storage at 5 degrees C (+/-) 3 degrees C.	5 +/- 3 degrees C		Storage at 5 degrees C (+/-) 3 degrees C.
C133865	PQ/CMC Storage Conditions Terminology	C133936	Temperature -20 (+/-) 5 Degrees C	Storage at -20 degrees C (+/-) 5 degrees C.	-20 +/- 5 degrees C		Storage at -20 degrees C (+/-) 5 degrees C.
C133865	PQ/CMC Storage Conditions Terminology	C133940	Temperature 40 (+/-) 2 Degrees C and Relative Humidity Not More Than 25%	Storage at 40 degrees C (+/-) 2 degrees C and Relative Humidity not more than 25%.	40 degrees C +/- 2 degrees C/not more than (NMT) 25%RH		
C133865	PQ/CMC Storage Conditions Terminology	C134014	Temperature 25 (+/-) 2 Degrees C and Relative Humidity 60% (+/-) 5%	Storage at 25 degrees C (+/-) 2 degrees C and 60% Relative Humidity (+/-) 5% Relative Humidity.	25 +/- 2 degrees C/60% +/- 5%RH		Storage at 25 degrees C (+/-) 2 degrees C and 60% Relative Humidity (+/-) 5% Relative Humidity.
C133865	PQ/CMC Storage Conditions Terminology	C134015	Temperature 30 (+/-) 2 Degrees C and Relative Humidity 65% (+/-) 5%	Storage at 30 degrees C (+/-) 2 degrees C and 65% Relative Humidity (+/-) 5% Relative Humidity.	30 +/- 2 degrees C/65% +/- 5%RH		Storage at 30 degrees C (+/-) 2 degrees C and 65% Relative Humidity (+/-) 5% Relative Humidity.
C133865	PQ/CMC Storage Conditions Terminology	C134016	Temperature 40 (+/-) 2 Degrees C and Relative Humidity 75% (+/-) 5%	Storage at 40 degrees C (+/-) 2 degrees C and 75% Relative Humidity (+/-) 5% Relative Humidity.	40 +/- 2 degrees C/75% +/- 5%RH		Storage at 40 degrees C (+/-) 2 degrees C and 75% Relative Humidity (+/-) 5% Relative Humidity.
C133865	PQ/CMC Storage Conditions Terminology	C134017	Temperature 30 (+/-) 2 Degrees C and Relative Humidity 75% (+/-) 5%	Storage at 30 degrees C (+/-) 2 degrees C and 75% Relative Humidity (+/-) 5% Relative Humidity.	30 +/- 2 degrees C/75% +/- 5%RH		Storage at 30 degrees C (+/-) 2 degrees C and 75% Relative Humidity (+/-) 5% Relative Humidity.
C133865	PQ/CMC Storage Conditions Terminology	C134018	Temperature 25 (+/-) 2 Degrees C and Relative Humidity 40% (+/-) 5%	Storage at 25 degrees C (+/-) 2 degrees C and 40% Relative Humidity (+/-) 5% Relative Humidity.	25 +/- 2 degrees C/40% +/- 5%RH		
C133865	PQ/CMC Storage Conditions Terminology	C134019	Temperature 30 (+/-) 2 Degrees C and Relative Humidity 35% (+/-) 5%	Storage at 30 degrees C (+/-) 2 degrees C and 35% Relative Humidity (+/-) 5% Relative Humidity.	30 degrees C +/- 2 degrees C/35%RH +/- 5%RH		
C133865	PQ/CMC Storage Conditions Terminology	C96148	Proprietary Storage Condition	Storage conditions according to protocols set by a business or company.	Proprietary		Storage conditions according to protocols set by a business or company.
C133866	PQ/CMC Study Type Terminology	C134026	Standard Environmental Condition	A single set of environmental conditions.	Standard		A single set of environmental conditions.  Example:  25 degree C, 60% RH, etc.
C133866	PQ/CMC Study Type Terminology	C134027	Cycled-Simple Environmental Condition	A set of two alternating environmental conditions.	Cycled-Simple		A set of two alternating environmental conditions. Example: freeze-thaw cycled study.
C133866	PQ/CMC Study Type Terminology	C134028	Complex Environmental Condition	Multiple phases with different sets of environmental conditions.	Complex		Multiple phases with different sets of environmental conditions. Examples: typically for inhalers, nebulizers, transportation studies etc.
C133866	PQ/CMC Study Type Terminology	C96087	Photostability Drug Study	A study conducted to determine the extent of effect that exposure to light has on a pharmaceutical product.	Photostability		Studies that evaluate the light sensitivity and stability of drugs.
C133867	PQ/CMC Test Method Origin Terminology	C96102	Compendial Method	Standardized methods and specification testing for generic pharmaceutical raw materials and finished products.	Compendial		Standardized methods and specification testing for generic pharmaceutical raw materials and finished products.
C133867	PQ/CMC Test Method Origin Terminology	C96103	Proprietary Method	An analysis that contains protected intellectual property preventing full disclosure of information about the method and/or restricting or limiting the use or distribution of the method or materials for its performance without express permission or licensing.	Proprietary		An analysis that contains protected intellectual property preventing full disclosure of information about the method and/or restricting or limiting the use or distribution of the method or materials for its performance without express permission or licensing.
C133867	PQ/CMC Test Method Origin Terminology	C96164	Code of Federal Regulations Method	A method described in the Code of Federal Regulations.	CFR		A method described in the Code of Federal Regulations.
C133868	PQ/CMC Test Usage Terminology	C134029	Release Determination	For determination of acceptability for use of a material, drug or a drug substance.	Release		For determination of acceptability for use of a material, drug or a drug substance.
C133868	PQ/CMC Test Usage Terminology	C134030	Stability Determination	For determination of maintained performance parameters on storage over time, of a material, drug or a drug substance.	Stability		For determination of maintained performance parameters on storage over time, of a material, drug or a drug substance.
C168622	PQ/CMC Strength Operator Terminology	C48660	Not Applicable	Determination of a value is not relevant in the current context.	Not Applicable	NA	Determination of a value is not relevant in the current context.
C168622	PQ/CMC Strength Operator Terminology	C48793	Equivalent	A person or thing equal to another in value or measure or force or effect or significance etc.; being essentially equal to something.	EQ		
C168622	PQ/CMC Strength Operator Terminology	C61583	Greater Than or Equal To	A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest exceeds the other object in one of these ways.	NLT (not less than)		A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest exceeds the other object in one of these ways.
C168622	PQ/CMC Strength Operator Terminology	C61584	Greater Than	A statement about the relative size or order of two objects specifying that an object of interest exceeds another object in quantity or measure or value or status.	MT (more than)		A statement about the relative size or order of two objects specifying that an object of interest exceeds another object in quantity or measure or value or status.
C168622	PQ/CMC Strength Operator Terminology	C61585	Less Than	A statement about the relative size or order of two objects specifying that an object of interest is smaller than another object in quantity or measure or value or status.	LT (less than)		A statement about the relative size or order of two objects specifying that an object of interest is smaller than another object in quantity or measure or value or status.
C168622	PQ/CMC Strength Operator Terminology	C61586	Less Than or Equal To	A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest is smaller than the other object in one of these ways.	NMT (not more than)		A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest is smaller than the other object in one of these ways.
C168624	PQ/CMC Organization-Site Identifier Type Terminology	C134003	Data Universal Numbering System	A proprietary system developed and regulated by Dun & Bradstreet that assigns a unique nine digit numeric identifier to a single business entity location.	DUNS		A proprietary system developed and regulated by Dun & Bradstreet that assigns a unique nine digit numeric identifier to a single business entity location.
C168624	PQ/CMC Organization-Site Identifier Type Terminology	C134004	Facility FDA Establishment Identifier	A unique identifier assigned by the Food and Drug Administration (FDA) to track inspections of a regulated establishment or facility. They are also used to track generic drug user fee acts (GDUFA) facility fee payments.	FEI		A unique identifier assigned by the Food and Drug Administration (FDA) to track inspections of a regulated establishment or facility. They are also used to track generic drug user fee acts (GDUFA) facility fee payments.
C168624	PQ/CMC Organization-Site Identifier Type Terminology	C134005	Central File Number	A seven digit number assigned by the Food and Drug Administration (FDA).	CFN		A seven digit number assigned by the Food and Drug Administration (FDA).
C168624	PQ/CMC Organization-Site Identifier Type Terminology	C17998	Unknown	Not known, observed, recorded; or reported as unknown by the data contributor.	Unknown		Not known, not observed, not recorded, or refused.
C168627	PQ/CMC Strength Type Terminology	C168628	Drug Component Mass	The mass of the active and inactive substances in a drug component.	Mass		The amount of active and/or inactive substance of a drug component.
C168627	PQ/CMC Strength Type Terminology	C45420	Biochemical Activity	A measurable amount of a specific function or role performed by a entity in a biophysical process, biochemical reaction, or biochemical process.	Activity		A measure of a property related to therapeutic or biological effect. Example, enzyme activity.
C176675	PQ/CMC Drug Product Component Function Category Terminology	C2140	Adjuvant	An agent that enhances the activity or therapeutic effect of another pharmacologic substance without having much, if any, therapeutic impact by itself.	Adjuvant		An ingredient which augments or promotes the pharmacological effect of the active ingredient(s) without itself being considered active (note that adjuvants are used only with vaccines).
C176675	PQ/CMC Drug Product Component Function Category Terminology	C42637	Pharmaceutical Excipient	Any intentionally added component of a finished pharmaceutical product other than the claimed therapeutic or diagnostic ingredient(s). The excipients are added to facilitate administration or manufacture, improve product delivery, promote the consistent release and bioavailability of the drug, enhance stability, assist in product identification, or enhance other product characteristics. Pharmaceutical excipients do not affect therapeutic effects of the preparation or suitable tests or assays. The term does not apply to macromolecular compounds like albumin, or compounds like amino acids and sugars that are used in biological products, nor does it apply to process or product-related impurities (e.g. degradation products, residual solvents), or extraneous contaminants.	Inactive Ingredient		An ingredient that is added for a purpose other than the intended pharmacological action.
C176675	PQ/CMC Drug Product Component Function Category Terminology	C82533	Active Ingredient	The pharmaceutically active components of a preparation.	Active Ingredient		An ingredient that has the intended pharmacological action.
C176676	PQ/CMC Excipient Function Terminology	C176632	Emollient Excipient	A substance within a topical formulation that is used to promote softening and retention of moisture when applied to skin.	Emollient		Agent added to topical formulations to promote softening of the skin. Used in topical preparations to impart lubrication, spreading ease, texture, and softening of the skin and to counter the potentially drying/irritating effect of surfactants on the skin (e.g. skin protectant). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176633	Emulsion Stabilizing Excipient	A substance within a formulation that is used to stabilize a mixture and prevent against phase separation.	Emulsion stabilizing agent		Agent added to improve stability against phase separation. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176634	Foam Stabilizing Excipient	A substance within a foam formulation that is used to maintain or improve its stability.	Foam stabilizing agent		Agent added to improve physical stability of foam (e.g. foaming agent). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176635	Organoleptic Excipient	A substance within a formulation that modifies its color, flavor or taste.	Organoleptic agent		An agent added to modify color, flavor, taste (e.g. flavoring agent; flavor enhancer; sweetening agent; taste-masking agent).
C176676	PQ/CMC Excipient Function Terminology	C176636	Stabilizing Excipient	A substance within a formulation that is used to preserve its integrity and prevent its degradation.	Stabilizer		Agent added to preserve product integrity and prevent degradation (e.g. stabilizing agent; colloid stabilizing agent).
C176676	PQ/CMC Excipient Function Terminology	C176637	Absorption Modifying Excipient	A substance within a formulation that is used to enhance the bioavailability of the  agent by modifying its absorption properties.	Absorption modifier		An excipient included in formulations to improve the absorption of a pharmacologically active drug (e.g. permeation enhancer; transmucosal absorption enhancer; intestinal permeation enhancer; delivery agent; penetration enhancer; transdermal delivery agent).
C176676	PQ/CMC Excipient Function Terminology	C176638	Effervescent Excipient	A substance within a powder or tablet formulation that is used to produce carbon dioxide when placed in an aqueous solution.	Effervescent agent		Effervescent excipients are used in powders and tablets. They are commonly used with acidic agents to cause a reaction that produces carbon dioxide. The carbon dioxide leads to a fizzing of the effervescent powder. (Adapted from American Pharmaceutical Review)
C176676	PQ/CMC Excipient Function Terminology	C176639	Reducing Excipient	A substance within a formulation that reduces its oxidation state in order to optimize the properties of the active ingredient(s).	Reducing agent		Reduces oxidation state of product component to produce desired active component/ingredient.
C176676	PQ/CMC Excipient Function Terminology	C176640	Solubilizing Excipient	A substance within a formulation that enhances the solubility of another substance.	Solubilizing agent		Enhance solubility of the active substance. (Pharmaceutical Excipients: A review Shilpa P Chaudhari and Pradeep S Patil Marathwada Mitra Mandal's College of Pharmacy, Thergaon, Pune, Maharashtra, India.)
C176676	PQ/CMC Excipient Function Terminology	C176641	Tonicity Excipient	A substance within a liquid formulation that alters its osmotic potential.	Tonicity agent		Agent added to alter osmotic potential of liquid formulations. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176642	Adsorbent	A substance used to absorb fluid-like substances on their surface and to increase the dissolution rates of relatively water-insoluble drugs in order to make them easier to incorporate into solid dosage forms.	Adsorbent		Agent used to bind another component from within a formulation, acting as a carrier, reservoir or sequestrant (e.g. water-absorbing agent). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176643	Air Displacement Agent	A gaseous substance used to replace air in product packaging.	Air displacement		Agent used to replace air in a product or pack with a gas phase of known composition during manufacturing. Example is widely used In reactors/mixing tanks with liquid products (e.g. air overlay; gas blanket). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176644	Bulking Excipient	A substance within a formulation that is used to solidify its intended shape.	Bulking agent		To provide a pharmaceutically elegant freeze-dried cake. (Adapted from USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C176645	Carrier Excipient	A substance within a formulation that is used to interact with and enhance the properties of active ingredients.	Carrier		Agents designed to interact with, and enhance the properties, of active pharmaceutical ingredients (APIs). Carrier excipients promote various ingredient qualities and have become a valuable asset for drug formulators. Used to help deposit the active ingredient in the lung and may have a secondary role in diluting the active to ensure that dosages can be properly metered (e.g. solid carrier; sorbent; carbon dioxide). (Adapted from American Pharmaceutical Review)
C176676	PQ/CMC Excipient Function Terminology	C176646	Complexing Excipient	A substance within a formulation that is used to combine with other components in order to maintain or improve solubility or stability.	Complexing agent		Agent added to combine with another component, commonly to maintain or improve solubility or chemical stability. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176647	Denaturant	A substance added to a product containing alcohol in order to render it unfit for consumption.	Denaturant		Agent added to make unfit to drink an ethanol containing product.
C176676	PQ/CMC Excipient Function Terminology	C176648	Film Coating Excipient	An agent used to produce a film covering the outer surface of a solid formulation.	Film coating agent		Agent used to produce a cosmetic or functional layer on the outer surface of a dosage form. Agents used to mask unpleasant tastes or odors, improve ingestion and appearance, protect active ingredients from the environment, and modify the release of the active ingredient or product subcomponent (e.g. coating agent; film-forming agent; film former; granulating agent; granulating fluid; film-coating dispersion medium). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176649	Free Radical Scavenging Excipient	A substance within a formulation that interacts with free radicals to prevent their degrading activity on other components.	Free radical scavenger		Used to preferentially interact with oxidative or reductive free radicals that otherwise would result in degradation of formulation components.  (Adapted from USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C176650	Gelling Excipient	A substance within a semisolid formulation that produces a gel-like texture.	Gelling agent		Agent added to produce a gel texture in a product. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176651	Humectant Excipient	A substance within a topical formulation that is used to increase the solubility of the active ingredient, improve its penetration into skin and prolong its activity time.	Humectant		Humectants can be used in topical dosage forms to increase the solubility of a chemical compound's active ingredients, increasing the active ingredients' ability to penetrate skin, or its activity time. Examples: propylene glycol, sorbitol solution, ammonium alginate, cyclomethicone, glycerin, polydextrose, sodium hyaluronate, and sodium lactate.
C176676	PQ/CMC Excipient Function Terminology	C176652	Lyophilization Excipient	A substance within a formulation that aids in freeze-drying of the product.	Lyophilization aid		Agent added to produce suitable physical properties in a freeze-dried product. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176653	Matrix Forming Excipient	A polymer within a sustained-release formulation that maintains matrix rigidity over a prolonged period.	Matrix-forming agent		Polymers added to sustained release formulations to control and maintain the rigidity of the matrix over a prolonged period (e.g. sustained-release agent; matrix for sustained release; rate-controlling polymer for sustained release). (Adapted from \The Role of Oral Controlled Release Matrix Tablets in Drug Delivery Systems\, Ali Nokhodchi1, Shaista Raja1, Pryia Patel1, Kofi Asare-Addo BioImpacts, 2012, 2(4), 175-187)
C176676	PQ/CMC Excipient Function Terminology	C176654	Microencapsulating Excipient	A substance within a formulation that promotes the formation of tiny spherical particles.	Microencapsulating agent		Agent used to form microcapsules with desirable physical properties. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176655	Ointment Base	A non-aqueous, semisolid vehicle used as a foundation for ointment formulations.	Ointment base		A nonaqueous vehicle for topical products. The major component of an ointment and controls its physical properties. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176656	Opacifying Excipient	A substance within a formulation that reduces light transmission.	Opacifier		Agent added to reduce light transmission in a product (e.g. opacifying agent). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176657	Osmotic Excipient	A substance within a formulation that allows for a controlled rate of release by creating an osmotic pressure differential between the drug and the external environment.	Osmotic agent		Material used to provide osmotic pressure differential in osmotic pump based drug product delivery systems.
C176676	PQ/CMC Excipient Function Terminology	C176658	pH Modifying Excipient	A substance within a formulation that alters its acidity or basicity.	pH modifier		Substance added to alter the acidity or basicity (e.g. acidity regulator; acidifying agent/alkalizing agent; acid; base).
C176676	PQ/CMC Excipient Function Terminology	C176659	Polishing Excipient	A substance within a formulation that provides a sheen to coated tablets.	Polishing agent		Agent used to impart an attractive sheen to coated tablets (e.g. tablet polishing agent).
C176676	PQ/CMC Excipient Function Terminology	C176660	Ophthalmic Polymer	A polymer within ophthalmic formulations used to promote the retention of its active ingredients after application to the eye.	Polymers for ophthalmic use		Used in ophthalmic preparations to enhance the retention of active ingredients by reducing the amount of product that is lost from the eye when the patient blinks. In addition, polymers also can be components of artificial tears. (Adapted from USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C176661	Propellant	A substance used to create pressure within a container to expel the product within.	Propellant		Developing pressure in container which expels the product. Used in pharmaceuticals (nasal sprays and respiratory and topical formulations), cosmetics, and foods to provide force to expel contents from a container (e.g. aerosol propellant). (Pharmaceutical Excipients: A review Shilpa P Chaudhari and Pradeep S Patil Marathwada Mitra Mandal's College of Pharmacy, Thergaon, Pune, Maharashtra, India.  USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C176662	Release Modifying Excipient	A substance within a formulation that controls how the product is released.	Release modifying agent		Substances added to the formulation to alter the release profile of the active substance (e.g. release modifier; release agent; modifying agent; extended release agent; controlled release agent; latex particle coating agent).
C176676	PQ/CMC Excipient Function Terminology	C176663	Suppository Base	A solid or semisolid, hydrophilic or hydrophobic vehicle used as a foundation for suppository formulations.	Suppository base		Agent used as the carrier for other ingredients in suppository formulations. Used in the manufacture of suppositories (for rectal administration) and pessaries (for vaginal administration). They can be hydrophobic or hydrophilic, (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176664	Transdermal Delivery Excipient	A substance within a topical formulation that affects its penetration of the skin.	Transdermal delivery component		A component of a transdermal system otherwise not covered by other terms.
C176676	PQ/CMC Excipient Function Terminology	C176665	Transfer Ligand Excipient	A substance within a radiopharmaceutical formulation that allows for the transfer of a weaker chelating ligand to the principal chelating ligand or complexing moiety.	Transfer ligand		Used in the preparation radiopharmaceuticals to transfer a relatively weak chelating ligand to the principal chelating ligand or complexing moiety. (USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C176666	Viscosity Modifying Excipient	A substance within a formulation that alters its thickness or texture to optimize its administration.	Viscosity modifier		Viscosity modifiers are designed to change the thickness or texture of pharmaceutical ingredients. Viscosity modifiers can include such products as thickeners, texturizers, gelation agents and stiffening agents (e.g. stiffening agent; thickener; thickening agent; viscosity-increasing agent; firming agent). (Adapted from American Pharmaceutical Review)
C176676	PQ/CMC Excipient Function Terminology	C176667	Water Repelling Excipient	A substance within a formulation that enhances its hydrophobicity.	Water-repelling agent		An agent used to enhance hydrophobic properties.
C176676	PQ/CMC Excipient Function Terminology	C176668	Wetting Excipient	A substance within a liquid formulation that reduces its surface tension and allows for more uniform spreading and penetration of surfaces during application.	Wetting agent		An agent added to a liquid to reduce its surface tension and make it more effective in spreading over and penetrating surfaces.
C176676	PQ/CMC Excipient Function Terminology	C275	Antioxidant	A group of organic or inorganic substances capable of preventing the genotoxic and carcinogenic effects of free-radical compounds.  Antioxidants bind to and neutralize ('scavenge') free radicals, thereby transforming them into non-toxic compounds and blocking their genotoxic and carcinogenic effects.  This class of agents includes the vitamins C and E, the carotenoids, and selenium.  Organic antioxidants are found in high concentrations in fruits, seeds and vegetables. (NCI04)	Antioxidant		Agent used to stabilize a system against oxidative degradation. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C360	Chelating Agent	An inorganic or organic molecule which binds metal ions. Metal chelators are frequently polydentate, indicating that they form multiple bonds with the metal ion, resulting in more stable coordination complexes.	Chelating agent		Used to sequester ions from solution and to form stable complexes (e.g. sequestering agent). (Pharmaceutical Excipients: A review Shilpa P Chaudhari and Pradeep S Patil Marathwada Mitra Mandal's College of Pharmacy, Thergaon, Pune, Maharashtra, India.  USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C42647	Binder Excipient	An inactive ingredient of the solid pharmaceutical dosage form added to cement the active and inert components of tablets together to maintain cohesive and discrete portions. These are especially important in the production of time-release products. Binders provide the matrix from which the drug is gradually secreted. Binding agents which have adhesive properties are important excipients, especially for lozenges and tablets. The choice of the particular binder or thickening agent is dependent upon the desired properties of adhesive strength and thickness. Thus, one would be a better agent for a lozenge when slow dissolution in the mouth is desirable whereas another would provide more rapid disintegration for other purposes. The commonly used binder excipients in U.S.-manufactured drug products are microcrystalline cellulose and starch.	Binder		Impart cohesive qualities to powdered material (e.g. binding agent or wet binder). (Pharmaceutical Excipients: A review Shilpa P Chaudhari and Pradeep S Patil Marathwada Mitra Mandal's College of Pharmacy, Thergaon, Pune, Maharashtra, India.  USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C42648	Disintegrant Excipient	Disintegrant excipient is a therapeutically inactive ingredient of a solid pharmaceutical dosage form that helps the form to dissolve within the gastrointestinal tract to ensure full release of the pharmaceutically active material. Disintegration rate of the tablet may be the rate limiting step for the absorption of the drug. Currently, disintegrants have been developed to the point that disintegration is not usually the rate limiting step. The US Pharmacopeia sets a time limit for disintegration. Microcrystalline cellulose and starch are examples of disintegrants.	Disintegrant		An agent used to facilitate breakup or disintegration after administration. Functional components that are added to formulations to promote rapid disintegration into smaller units and to allow a drug substance to dissolve more rapidly. (Pharmaceutical Excipients: A review Shilpa P Chaudhari and Pradeep S Patil Marathwada Mitra Mandal's College of Pharmacy, Thergaon, Pune, Maharashtra, India.  USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C42650	Filler Excipient	A therapeutically inactive ingredient of a solid pharmaceutical dosage form that is used to increase the volume of the material to accommodate easier processing of the drug and to make it a suitable size for patient consumption Typical fillers include calcium phosphate (also an added source of both minerals), lactose, powder, sucrose powder.	Filler		Make up the bulk of solid unit dosage forms when drug itself is inadequate to produce the bulk. Components that are incorporated into tablet or capsule dosage forms to increase dosage form volume or weight (e.g. diluent; dry powder inhalation; bulking agent). (Pharmaceutical Excipients: A review Shilpa P Chaudhari and Pradeep S Patil Marathwada Mitra Mandal's College of Pharmacy, Thergaon, Pune, Maharashtra, India.  USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C42653	Lubricant Excipient	Lubricant excipient is a therapeutically inactive substance used to facilitate the release of stamped solid pharmaceutical dosage forms, e.g. tablets, out of the die once pressed, improving the efficiency of manufacturing. Magnesium stearate is an example.	Lubricant		Agent added to reduce friction effects during processing or use. Used to reduce the frictional forces between particles and between particles and metal-contact surfaces of manufacturing equipment (e.g. tablet ejection; antiadherent; antistat; glidant). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C42654	Glidant Excipient	An inactive ingredient of the pharmaceutical dosage form that is added to promote powder flow during the manufacture of pills.	Anticaking agent		Agent added to improve powder flow. Used to promote powder flow and to reduce the caking or clumping that can occur when powders are stored in bulk. In addition, glidants and anticaking agents reduce the incidence of bridging during the emptying of powder hoppers and during powder processing. (e.g. glidant). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C42656	Color Excipient	Therapeutically inactive dye or coloring agent that is a component of pharmaceutical product. There are more than 100 excipient colors approved by the FDA for pharmaceutical use.	Coloring agent		Agent to impart hue to a component (e.g. color retention agent, dye).
C176676	PQ/CMC Excipient Function Terminology	C42657	Printing Ink Excipient	The constituents of printing inks used to mark an ingested pharmaceutical dosage form.	Ink		A colored fluid or paste used for writing, drawing, typically used to identify a product and its strength.
C176676	PQ/CMC Excipient Function Terminology	C42659	Preservative Excipient	Chemicals that are added to drug products to prolong shelf life and maintain sterility. Protection of formulations, especially aqueous solutions, against microbial growth requires use of either antibacterial or antifungal preservatives. Generally, such agents are active against either bacteria or fungi but a few are active against both. The antimicrobials include but not limited to chlorobutanol, benzyl alcohol, sodium benzoate, sorbic acid, and phenol. The antioxidizing agents include butylated hydroxytoluene, hydroxyanisole, propyl gallate, and sulfites. The necessary addition of preservatives for both safety and economy sometimes has been associated with significant adverse effects in certain patient populations.	Preservative		An agent added to extend the shelf-life of a formulation (e.g. antibacterial agent; antifungal agent preservative; fungicides; antimicrobial preservative; antiviral agent preservative; viricides; sterilizing agent; glazing agent).
C176676	PQ/CMC Excipient Function Terminology	C42660	Suspending Excipient	Therapeutically inactive ingredient of pharmaceutical dosage form used to prevent aggregation of the active drug in liquid form, allowing uniform concentrations to be maintained for accurate dosing.	Suspending agent		A non-surface active polymer or a surface-active substance added to a suspension, to improve the separation of particles and to prevent settling or clumping (e.g. dispersing agent).
C176676	PQ/CMC Excipient Function Terminology	C42662	Dispersing Excipient	An inactive ingredient of the pharmaceutical dosage form that is added to disperse a solid, poorly-water-soluble pharmacological agent in a liquid and to prevent clumping of the drug.	Dispersing agent		Agent added to prevent aggregation in liquid formulations. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C42739	Surfactant Excipient	A surface active agent (surfactant), in dilute solution, moves to the interface of a two-phase system and reduces the surface free energy. This permits the two phases to mix more completely. Surface active agents are usually soluble both in aqueous and non-aqueous solvents. They are exemplified by soap-type molecules (long chain fatty acid salts) such as sodium lauryl sulfate.	Surfactant		Substances used to enhance stability by reducing surface tension (e.g. anionic surfactant; cationic surfactant; nonionic surfactant).
C176676	PQ/CMC Excipient Function Terminology	C45790	Solvent	A liquid that dissolves or that is capable of dissolving; the component of a solution that is present in greater amount.	Solvent		The liquid in which a solute is dissolved to form a solution.
C176676	PQ/CMC Excipient Function Terminology	C53306	Cryoprotective Agent	A substance that is used to protect from the effects of freezing, largely by preventing large ice crystals from forming.	Cryoprotectant		Agent added to prevent cell damage during freeze-drying. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C55826	Plasticizer	A substance added to plastics or other materials to make or keep them soft or pliable.	Plasticizer		Agent added to promote flexibility of films or coatings (e.g. plasticizing agent). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C70815	Buffer	An ionic compound that resists changes in its pH.	Buffering agent		Agent used to stabilize pH within a defined range.  (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C73477	Emulsifying Excipient	A chemical substance that functions to stabilize an emulsion.	Emulsifying Excipient		Agent added to promote mixing of immiscible phases (e.g. fluorocarbon emulsifying agent; emulsifier; emulsifying salt). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C89528	Adhesive Device	Any substance that affixes 2 or more parts or tissues together.	Adhesive		Substance capable of bonding together two surfaces (e.g. bioadhesive material).
C176676	PQ/CMC Excipient Function Terminology	C927	Drug Vehicle	A substance used as a medium for administration of a pharmaceutical.	Vehicle		A substance that facilitates the use of a drug, or other material mixed with it, not covered by other terms (e.g. oleaginous vehicle).
C176677	PQ/CMC Units of Measure Terminology	C105491	Kilodalton	A unit of atomic mass equal to one thousand daltons.	ku	kiloDalton	
C176677	PQ/CMC Units of Measure Terminology	C122629	Actuation Dosing Unit	A dosing unit equal to the amount of active ingredient(s) contained in an actuation.	{actuation}	actuation	
C176677	PQ/CMC Units of Measure Terminology	C139134	Linear Foot Pound	A unit of energy that equals the work required to move one pound a distance of one foot in the direction of the applied force.	[lbf_av]	pound foot	
C176677	PQ/CMC Units of Measure Terminology	C154859	Microsiemens	A unit of electrical conductance, admittance, and susceptance equal to one millionth of a Siemens (10E-6 Siemens).	umho	micromhos	
C176677	PQ/CMC Units of Measure Terminology	C171022	Particle Total Count	A quantitative value for the total particles in a sample.	{tot}	particles	
C176677	PQ/CMC Units of Measure Terminology	C176690	Millisiemens	One-thousandth of a siemens, a decimal fraction of the SI unit of electrical conductance and admittance siemens and is equal to 10^-3 siemens.	ms	millisiemens	
C176677	PQ/CMC Units of Measure Terminology	C25301	Day	The time for Earth to make a complete rotation on its axis; ordinarily divided into twenty-four hours, equal to 86 400 seconds. This also refers to a specific day.	d	day	
C176677	PQ/CMC Units of Measure Terminology	C25529	Hour	A unit measure of time equal to 3,600 seconds or 60 minutes. It is approximately 1/24 of a median day.	h	hour	
C176677	PQ/CMC Units of Measure Terminology	C28251	Millimeter	A metric unit of length equal to one thousandth of a meter (10E-3 meter) or approximately 0.03937 inch.	mm	millimeter	
C176677	PQ/CMC Units of Measure Terminology	C28252	Kilogram	A basic SI unit of mass. It is defined as the mass of an international prototype in the form of a platinum-iridium cylinder kept at Sevres in France. A kilogram is equal to 1,000 grams and 2.204 622 6 pounds.	kg	kilogram	
C176677	PQ/CMC Units of Measure Terminology	C28253	Milligram	A metric unit of mass equal to one thousandth of a gram or 1000 micrograms. One milligram equals approximately 0.015 432 grain or 35.274 x 10E-6 ounce.	mg	milligram	
C176677	PQ/CMC Units of Measure Terminology	C28254	Milliliter	A unit of volume equal to one millionth (10E-6) of a cubic meter, one thousandth of a liter, one cubic centimeter, or 0.061023 7 cubic inch. A cubic centimeter is the CGS unit of volume.	mL	cm3 || cubic centimeter || milliliter	
C176677	PQ/CMC Units of Measure Terminology	C29844	Week	Any period of seven consecutive days.	wk	week	
C176677	PQ/CMC Units of Measure Terminology	C29846	Month	One of the 12 divisions of a year as determined by a calendar. It corresponds to the unit of time of approximately to one cycle of the moon's phases, about 30 days or 4 weeks.	mo	month	
C176677	PQ/CMC Units of Measure Terminology	C29848	Year	A period of time that it takes for Earth to make a complete revolution around the sun, approximately 365 days; a specific one year period.	a	year	
C176677	PQ/CMC Units of Measure Terminology	C41127	Unified Atomic Mass Unit	The non-SI unit of mass in terms of which the masses of individual atoms and molecules are expressed. Unified atomic mass unit is defined as one twelfth of the mass of an unbound atom of the carbon-12 nuclide, the predominant isotope of carbon, at rest and in its ground state. It is equal to 1.6606x10(E-27) kg (approximately).	u	Atomic Mass Unit || Dalton	
C176677	PQ/CMC Units of Measure Terminology	C41139	Meter	A unit of linear measure in the metric system, one of the seven base units of the International System of Units (Systeme International d'Unites, SI). A meter is defined as the length of the path traveled by light in a vacuum during a time interval of 1/299 792 458 of a second and is equal to 1.093 61 yards.	m	meter	
C176677	PQ/CMC Units of Measure Terminology	C42535	Second	A unit of time, one of the seven base units of the International System of Units (Systeme International d'Unites, SI). The second is the duration of 919 263 177 0 periods of the specified light radiation corresponding to the transition between the two hyperfine levels of the caesium 133 atom in its ground state at 0 K. According to the convention, 60 seconds constitute one minute; 3,600 seconds constitute one hour.	s	second	
C176677	PQ/CMC Units of Measure Terminology	C42537	Kelvin	A basic unit of thermodynamic temperature, one of the seven base units of the International System of Units (Systeme International d'Unites, SI). It is 1/273.16th of the thermodynamic temperature of the triple point of water. This sets the size of the kelvin unit for temperature differences and defines the thermodynamic temperature of an equilibrium mixture of waters ice-liquid-vapor as 273.16 K, where 0 K is the lowest possible temperature ("absolute zero").	K	degree Kelvin	
C176677	PQ/CMC Units of Measure Terminology	C42539	Mole	A unit of amount of substance, one of the seven base units of the International System of Units (Systeme International d'Unites, SI). It is the amount of substance that contains as many elementary units as there are atoms in 0.012 kg of carbon-12. When the mole is used, the elementary entities must be specified and may be atoms, molecules, ions, electrons, other particles, or specified groups of such particles.	mol	mole	
C176677	PQ/CMC Units of Measure Terminology	C42543	Radian	A SI-derived unit of plane angle measurement defined and named by James Thomson in 1873. One radian is the plane angle between two radii of a circle that cuts off on the circumference an arc equal in length to the radius. There are 2pi radians in a complete circle. SI units: m/m = 1.	rad	radian	
C176677	PQ/CMC Units of Measure Terminology	C42546	Newton	A SI derived unit of force. The force which, when applied in a vacuum to a body having a mass of one kilogram, causes an acceleration of one meter per second squared. It is equal to 10E5 dynes.	N	Newton	
C176677	PQ/CMC Units of Measure Terminology	C42559	Degree Celsius	A unit of temperature of the temperature scale designed so that the freezing point of water is 0 degrees and the boiling point is 100 degrees at standard atmospheric pressure. The current official definition of the Celsius sets 0.01 C to be at the triple point of water and a degree to be 1/273.16 of the difference in temperature between the triple point of water and absolute zero. One degree Celsius represents the same temperature difference as one Kelvin.	Cel	degree Celsius	
C176677	PQ/CMC Units of Measure Terminology	C42569	Square Meter	A SI unit of area measurement equal to a square whose sides are one meter long. Square meter is equal to 10,000 square centimeters; 0.01 are; 1.196 square yards; 10.76 square feet; 1550 square inches.	m2	square meter	
C176677	PQ/CMC Units of Measure Terminology	C42570	Cubic Meter	A SI unit of volume or capacity equal to the volume of a cube with edges one meter in length. It is equal to 1,000 liters; 1,000 cubic decimeters; 10(e+6) cubic centimeters; 25.3 cubic feet; 6.29 barrels.	m3	cubic meter	
C176677	PQ/CMC Units of Measure Terminology	C44277	Degree Fahrenheit	A unit of temperature of the temperature scale designed so that the freezing point of water is 32 degrees and the boiling point is 212 degrees, placing the boiling and melting points of water 180 degrees apart. One degree Fahrenheit is 5/9ths of a kelvin (or of a degree Celsius), and minus 40 degrees Fahrenheit is equal to minus 40 degrees Celsius.	[degF]	degree Fahrenheit	
C176677	PQ/CMC Units of Measure Terminology	C45997	pH	Quantity of dimension one used to express on a scale from 0 to 14 the amount-of-substance concentration of hydrogen ion of dilute aqueous solution, calculated as the logarithm of the reciprocal of hydrogen-ion concentration in gram atoms per liter.	[pH]	pH	
C176677	PQ/CMC Units of Measure Terminology	C48152	Microgram	A metric unit of mass equal to one millionth of a gram or one thousandth of a milligram.	ug	microgram	
C176677	PQ/CMC Units of Measure Terminology	C48153	Microliter	A unit of volume accepted for use with the SI and equal to one millionth of a liter (10E-6 liter).	uL	microliter	
C176677	PQ/CMC Units of Measure Terminology	C48154	Minute	A unit measure of time equal to 60 seconds.	min	minute	
C176677	PQ/CMC Units of Measure Terminology	C48155	Gram	The metric unit of mass equal to one thousandth of a kilogram. One gram equals approximately 15.432 grains or 0.035 273 966 ounce.	g	gram	
C176677	PQ/CMC Units of Measure Terminology	C48479	Can Dosing Unit	A dosing unit equal to the amount of active ingredient(s) contained in a can.	{can}	can	
C176677	PQ/CMC Units of Measure Terminology	C48500	Inch	A traditional unit of length equal to 1/12 of a foot or 2.54 centimeters.	[in_i]	inch	
C176677	PQ/CMC Units of Measure Terminology	C48505	Liter	The non-SI unit of volume accepted for use with the SI. One liter is equal to cubic decimeter, or one thousandth of cubic meter, or 1000 cubic centimeters, or approximately 61.023 744 cubic inches.	L	liter	
C176677	PQ/CMC Units of Measure Terminology	C48509	Micromole	A unit of amount of substance equal to a millionth of a mole.	umol	micromole	
C176677	PQ/CMC Units of Measure Terminology	C48510	Micron	A unit of length in metric system equal to 10E-6 meter, or micrometer.	um	micrometer || micron	
C176677	PQ/CMC Units of Measure Terminology	C48513	Millimole	A unit of amount of substance equal to 0.001 mole.	mmol	millimole	
C176677	PQ/CMC Units of Measure Terminology	C48516	Nanogram	The metric unit of mass equal to one billionth of a gram (10E-9 gram) or one thousandth of a milligram.	ng	nanogram	
C176677	PQ/CMC Units of Measure Terminology	C48517	Nanomole	A unit of amount of substance equal to 10E-9 mole.	nmol	nanomole	
C176677	PQ/CMC Units of Measure Terminology	C48519	Ounce	The traditional unit of mass. The avoirdupois ounce is equal to 1/16 pound, or 28.349 5 grams, or 0.911 457 troy ounce.	[oz_av]	ounce	
C176677	PQ/CMC Units of Measure Terminology	C48523	Part Per Million	A unit of proportion equal to 10E-6.	[ppm]	parts per million	
C176677	PQ/CMC Units of Measure Terminology	C48527	Percent Mass per Volume	A unit of percentage concentration expressed as a fraction of a component by mass in the entire volume of a resulting mixture. The standard conditions for temperature and pressure apply. The mass-volume percentage is used for liquid solute/solution systems and systems containing solid phase components. The concept also refers to the weight-volume percentage concentration given that standard values for specific gravity of the solute are used.	%{WeightToVolume}	percent weight per volume	
C176677	PQ/CMC Units of Measure Terminology	C48528	Percent Mass per Mass	A unit of percentage concentration expressed as a fraction of a solute by mass in the entire mass of a resulting solution. The concept also refers to the weight-weight percentage concentration given that standard values for specific gravity of the solute and the solution are used.	%{WeightToWeight}	percent weight/weight	
C176677	PQ/CMC Units of Measure Terminology	C48529	Pint	A United States liquid unit equal to 16 fluid ounces; two pints equal one quart.	[pt_us]	pints (US Dry)	
C176677	PQ/CMC Units of Measure Terminology	C48531	Pound	The traditional unit of mass. By international agreement, one avoirdupois pound is equal to exactly 0.453 592 37 kilogram, 16 ounces, or 1.215 28 troy pounds.	[lb_av]	pound	
C176677	PQ/CMC Units of Measure Terminology	C48542	Tablet Dosing Unit	A dosing unit equal to the amount of active ingredient(s) contained in a tablet.	{tbl}	tablet	
C176677	PQ/CMC Units of Measure Terminology	C48551	Vial Dosing Unit	A dosing unit equal to the amount of active ingredient(s) contained in a single vial.	{vial}	vial	
C176677	PQ/CMC Units of Measure Terminology	C48570	Percent Unit	A unit for expressing a number as a fraction of hundred (on the basis of a rate or proportion per hundred).	%	percent	
C176677	PQ/CMC Units of Measure Terminology	C48571	Percent Volume per Volume	A unit of percentage concentration expressed as a fraction of a component by volume s in the entire volume of a resulting mixture. The unit denotes a number of milliliters of a solute per 100 milliliters of solution. The standard conditions for temperature and pressure apply.	%{VolumeToVolume}	percent volume per volume	
C176677	PQ/CMC Units of Measure Terminology	C48579	International Unit	The unitage assigned by the WHO to International Biological Standards - substances, classed as biological according to the criteria provided by WHO Expert Committee on Biological Standardization (e.g. hormones, enzymes, and vaccines), to enable the results of biological and immunological assay procedures to be expressed in the same way throughout the world. The definition of an international unit is generally arbitrary and technical, and has to be officially approved by the International Conference for Unification of Formulae.	[IU]	international unit	
C176677	PQ/CMC Units of Measure Terminology	C48580	Gallon US	The US unit of liquid volume legally defined as 3785.411784 milliliters (3.785 411 784 liters), or 231 cubic inches. The US gallon holds 4 liquid quarts; the gallon of water gallon weighs approximately 8.33 pounds.	gal	gallon	
C176677	PQ/CMC Units of Measure Terminology	C49668	Centimeter	A basic unit of length in the former CGS version of metric system, equal to one hundredth of a meter or approximately 0.393 700 787 inch.	cm	centimeter	
C176677	PQ/CMC Units of Measure Terminology	C64551	Picogram	The metric unit of mass equal to one trillionth of a gram (10E-12 gram).	pg	picogram	
C176677	PQ/CMC Units of Measure Terminology	C64778	Enzyme Unit	A unit of catalytic activity measurement defined as the quantity of a particular enzyme that catalyzes the transformation of one micromole of the substrate per minute under standard conditions for specified assay system. The usage of this unit is discouraged in favor of the katal by International Federation of Clinical Chemistry and Laboratory Medicine due to lack of its coherence with the SI system. One enzyme unit is equal to 16.667 nanokatals.	U	catalytic activity unit	
C176677	PQ/CMC Units of Measure Terminology	C65045	Picomole	A unit of amount of substance equal to a trillionth (10E-12) of a mole.	pmol	picomole	
C176677	PQ/CMC Units of Measure Terminology	C67015	Milligram per Deciliter	A unit of mass concentration defined as the concentration of one milligram of a substance in unit volume of the mixture equal to one cubic deciliter or 100 cubic centimeters. It is also a unit of mass density (volumic mass) defined as the density of substance which mass equal to one milligram occupies the volume one cubic deciliter or 100 cubic centimeters.	mg%	milligram per 100 milliliters of solution	
C176677	PQ/CMC Units of Measure Terminology	C67196	British Thermal Unit	A non-SI unit of energy equal to the amount of heat required to raise the temperature of one pound avoirdupois of air-free water by one degree Fahrenheit at a constant pressure of one atmosphere. The value of the unit depends on the initial temperature of the water and varies in the range of approximately 1.054 - 1.060 joules.	[Btu]	British Thermal Unit	
C176677	PQ/CMC Units of Measure Terminology	C67318	Milliosmole	A unit of osmotic pressure equal to one thousandth of osmole or osmotic pressure of 0.001 molar solution of a substance that does not dissociate.	mosm	milliosmole	
C176677	PQ/CMC Units of Measure Terminology	C67328	Nanometer	A metric unit of length equal to one billionth of a meter (10E-9 meter). Nanometer is used as a unit for light wavelength measurement.	nm	nanometer	
C176677	PQ/CMC Units of Measure Terminology	C67334	Pound per Square Inch	A traditional unit of pressure equivalent to 6.894757 kilopascals, or 703.0696 kilograms per square meter, or 51.71507 millimeters of mercury.	[psi]	pounds per square inch	
C176677	PQ/CMC Units of Measure Terminology	C68667	Degree Unit of Plane Angle	A unit of plane angle measurement equal to the length of the arc cut out by the angle, divided by the circumference of the circle, and multiplied by 360. The symbol for degrees is a small superscript circle. One radian is about 57 degrees and one degree is pi/180 radians.	deg	degrees to rotation	
C176677	PQ/CMC Units of Measure Terminology	C68742	Colony Forming Unit	The minimum number of separable cells which is able to produce a detectable colony of progeny. Examples of CFU usage include, but are not limited to, the measurement of the number of viable bacteria present in the environment, and the ability of stem cells to produce cells of single or multiple lineages.	[CFU]	colony forming units	
C176677	PQ/CMC Units of Measure Terminology	C69112	Part per Thousand	A unit of proportion equal to 10E-3.	[ppth]	parts per thousand	
C176677	PQ/CMC Units of Measure Terminology	C69118	Quart Dry US	A unit of volume in US customary measure system for dry volumes equal to 67.201 cubic inches, or approximately 1.101 221 liters.	[qt_us]	quarts (US Dry)	
C176677	PQ/CMC Units of Measure Terminology	C70471	Kilogram-Force	A deprecated unit of force defined as a force that produces an acceleration equal to the acceleration of gravity when acting on a mass of one kilogram. One kilogram-force is equal to 9.80665 newtons.	kgf	kilopond	
C176677	PQ/CMC Units of Measure Terminology	C70565	Part Per Billion	A unit of proportion equal to 10E-9.	[ppb]	parts per billion	
C176677	PQ/CMC Units of Measure Terminology	C70566	Part Per Trillion	A unit of proportion equal to 10E-12.	[pptr]	parts per trillion	
C176677	PQ/CMC Units of Measure Terminology	C73783	Unit per Square Meter per Day	An arbitrary unit of substance rate expressed in unit(s) per square meter per period of time equal to twenty-four hours.	(m2.d)	meter squared in 24 hours	
C176677	PQ/CMC Units of Measure Terminology	C96599	Ehrlich Unit	A unit of measure equal to one milligram of urobilinogen per deciliter.	[EU]	Ehrlich unit	
C185181	PQ/CMC Expiration Date Classification Terminology	C185182	Master File or Application Approved Indicator	An approved indicator for an application or a master file when the Expiration Date Classification or Retest Date Classification is set to "Approved".	Approved		After an application or a master file has been approved, then the Expiration Date Classification or Retest Date Classification is set to "Approved".
C185181	PQ/CMC Expiration Date Classification Terminology	C185186	Adequate Substance Process Understanding	The applicant has appropriate process understanding to demonstrate that the quality of the subsequent API can be satisfactorily controlled. Adequate applies to substances only.	Adequate		The applicant has appropriate process understanding to demonstrate that the quality of the subsequent API can be satisfactorily controlled. Adequate applies to substances only.
C185181	PQ/CMC Expiration Date Classification Terminology	C185188	Proposed Substance Date Change	For a Supplement that's changing the expiration date or the retest date that is already classified as "Approved" for the drug product or drug substance, the changed expiration date classification or retest date classification would be "Proposed".	Proposed		For a Supplement that's changing the expiration date or the retest date that is already classified as "Approved" for the drug product or drug substance, the changed expiration date classification or retest date classification would be "Proposed".
C185181	PQ/CMC Expiration Date Classification Terminology	C48660	Not Applicable	Determination of a value is not relevant in the current context.	Not Applicable	NA	Determination of a value is not relevant in the current context.
C185189	PQ/CMC Interval Description Code Terminology	C96150	Immediate Testing	Sample is tested immediately.	Immediate Testing		Sample is tested immediately.
C185189	PQ/CMC Interval Description Code Terminology	C96151	Delayed Testing	Sample is not tested immediately.	Delayed Testing		Sample is not tested immediately.
C185189	PQ/CMC Interval Description Code Terminology	C96153	Frozen Delayed Testing	Sample is frozen and not tested immediately.	Frozen Delayed Testing		Sample is frozen and not tested immediately.
C185189	PQ/CMC Interval Description Code Terminology	C96154	Ambient Delayed Testing	Sample is stored at ambient conditions and not tested immediately.	Ambient Delayed Testing		Sample is stored at ambient conditions and not tested immediately.
C185189	PQ/CMC Interval Description Code Terminology	C96155	Refrigerated Delayed Testing	Sample is refrigerated and not tested immediately.	Refrigerated Delayed Testing		Sample is refrigerated and not tested immediately.
C203345	PQ/CMC Capsule Shell Classification Terminology	C203348	Hard Gelatin Capsule Shell	A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of gelatin in which one or more drug substances and/or inert materials are enclosed.	Hard Gelatin Capsule Shell		A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of gelatin in which one or more drug substances and/or inert materials are enclosed.
C203345	PQ/CMC Capsule Shell Classification Terminology	C203349	Hard HPMC Capsule Shell	A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of hydroxypropyl methylcellulose (HPMC) in which one or more drug substances and/or inert materials are enclosed.	Hard HPMC Capsule Shell		A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of hydroxypropyl methylcellulose (HPMC) in which one or more drug substances and/or inert materials are enclosed.
C203345	PQ/CMC Capsule Shell Classification Terminology	C203350	Hard Pullulan Capsule Shell	A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of pullulan in which one or more drug substances and/or inert materials are enclosed.	Hard Pullulan Capsule Shell		A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of pullulan in which one or more drug substances and/or inert materials are enclosed.
C203345	PQ/CMC Capsule Shell Classification Terminology	C203351	Hard PVA Capsule Shell	A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of polyvinyl alcohol (PVA) copolymer in which one or more drug substances and/or inert materials are enclosed.	Hard PVA Capsule Shell		A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of polyvinyl alcohol (PVA) copolymer in which one or more drug substances and/or inert materials are enclosed.
C203345	PQ/CMC Capsule Shell Classification Terminology	C203352	Hard Starch Capsule Shell	A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of starch in which one or more drug substances and/or inert materials are enclosed.	Hard Starch Capsule Shell		A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of starch in which one or more drug substances and/or inert materials are enclosed.
C203345	PQ/CMC Capsule Shell Classification Terminology	C203353	Soft Gelatin Capsule Shell	A one-piece, hermetically sealed soft gelatin casing with liquid, suspension, or semisolid materials enclosed.	Soft Gelatin Capsule Shell		A one-piece, hermetically sealed soft gelatin casing with liquid, suspension, or semisolid materials enclosed.
C203346	PQ/CMC Release Mechanism Terminology	C203359	Matrix Drug Release	Drug release controlled by homogeneous distribution of the drug throughout a matrix. Drug molecules are released as the matrix dissolves.	Matrix		Drug release controlled by homogeneous distribution of the drug throughout a matrix. Drug molecules are released as the matrix dissolves.
C203346	PQ/CMC Release Mechanism Terminology	C203360	Osmotic Pump Drug Release	Drug release controlled by an osmotic agent that acts to imbibe water from the surrounding medium via a semipermeable membrane which is permeable to water but impermeable to drug. The delivery of the active agent from the device is controlled by water influx across the semipermeable membrane forcing the drug out of an orifice in the device.	Osmotic Pump		Drug release controlled by an osmotic agent that acts to imbibe water from the surrounding medium via a semipermeable membrane which is permeable to water but impermeable to drug. The delivery of the active agent from the device is controlled by water influx across the semipermeable membrane forcing the drug out of an orifice in the device.
C203346	PQ/CMC Release Mechanism Terminology	C203361	Reservoir Drug Release	Drug release controlled by the thickness and the dissolution rate of the encapsulating membrane surrounding the drug core.	Reservoir		Drug release controlled by the thickness and the dissolution rate of the encapsulating membrane surrounding the drug core.
C203347	PQ/CMC Substance Name Type Terminology	C142585	International Nonproprietary Name	A unique, internationally consistent and globally recognized name which identifies pharmaceutical substances or active pharmaceutical ingredients and is public property.	INN		International Nonproprietary Name (INN) is a unique name that is globally recognized and is public property.
C203347	PQ/CMC Substance Name Type Terminology	C203354	Company Identifier	An identifier assigned by a company.	Company ID/Code		An identifier or code assigned by the company.
C203347	PQ/CMC Substance Name Type Terminology	C203355	GSRS Preferred Term	The preferred term, preferred substance name and display name identified as PT within FDA Global Substance Registration System (GSRS).	GSRS Preferred Term		The default display name identified within FDA Global Substance Registration System (GSRS).
C203347	PQ/CMC Substance Name Type Terminology	C203356	IUPAC Name	A name assigned to a chemical substance according to the systematic nomenclature rules defined by the International Union of Pure and Applied Chemistry (IUPAC).	IUPAC Name		A name assigned to a chemical substance according to the systematic nomenclature rules defined by the International Union of Pure and Applied Chemistry (IUPAC).
C203347	PQ/CMC Substance Name Type Terminology	C203357	Chemical Systematic Name	A name derived directly from the chemical structure.	Systematic Name		A name derived directly from the chemical structure.
C203347	PQ/CMC Substance Name Type Terminology	C203358	USP-NF Established Name	A unique nonproprietary name assigned to drugs and biologics by the United States Pharmacopeia (USP) or excipients by the National Formulary (NF).	USP-NF Established Name		A unique nonproprietary name assigned to drugs and biologics by the United States Pharmacopeia (USP) or excipients by the National Formulary (NF).
C203347	PQ/CMC Substance Name Type Terminology	C54682	CAS Number	A unique numerical identifier assigned, by the Chemical Abstract Service (CAS), a division of the American Chemical Society, to chemical compounds, polymers, biological sequences, mixtures, and alloys.	CAS Number		A unique numerical identifier assigned by the Chemical Abstract Service (CAS), a division of the American Chemical Society, to chemical compounds, polymers, biological sequences, mixtures, and alloys.
C203347	PQ/CMC Substance Name Type Terminology	C71898	Proprietary Name	The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies.	Brand		The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies.
C203347	PQ/CMC Substance Name Type Terminology	C95517	ISBT-128 Donation Identification Number	A globally unique identifier that is assigned to each collection and each pooled product. The identifier is composed of four parts: a Facility Identification Number (FIN), a year of assignment, a serial number, and flag characters.	ISBT-128 DIN		A globally unique identifier that is assigned to each collection and each pooled product. The identifier is composed of four parts: a Facility Identification Number (FIN), a year of assignment, a serial number, and flag characters.
C203347	PQ/CMC Substance Name Type Terminology	C96973	United States Adopted Name	A unique nonproprietary name assigned to drugs and biologics by the United States Adopted Names Council (USAN).	USAN		A unique nonproprietary name assigned to drugs and biologics by the United States Adopted Names Council (USAN).
C203347	PQ/CMC Substance Name Type Terminology	C97054	Generic Name	A non-branded or registered name that meant for common use.	Generic Name	Common Name	A non-branded or registered name meant for common use.
C203777	PQ/CMC Ingredient Location Terminology	C203881	Active Core Granule	A granule core containing an active pharmaceuitcal ingredient (API) as opposed to the API being in the coating and not in the core.	Active core/granulate		The location of the ingredient of interest is within a starter core (granulate, bead or tablet) with no applied coating.
C203777	PQ/CMC Ingredient Location Terminology	C203882	Extragranular Ingredient	An ingredient that is added after granulation and located outside of the granule.	Extragranular		The location of the ingredient of interest is external to the granules (granulates)
C203777	PQ/CMC Ingredient Location Terminology	C203883	Intragranular Ingredient	An ingredient that is added before granulation and located within the granule.	Intragranular		The location of the ingredient of interest is within the granules (granulates)
C203778	PQ/CMC Release Profile Terminology	C42669	Immediate Release Dosage Form	A solid, semi-solid, solution or suspension that is designed to release its active and/or inert ingredient(s) upon administration with no enhanced, delayed or extended release effect.	Immediate Release Profile		A design in which no deliberate effort has been made to modify the API release rate. In the case of capsules and tablets, the inclusion or exclusion of a disintegrating agent is not interpreted as a modification.
C203778	PQ/CMC Release Profile Terminology	C42713	Extended Release Dosage Form	A solid, semi-solid, solution or suspension designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.	Extended-Release Profile		A design which makes the drug substance available over a prolonged period following administration, compared to that observed or anticipated for an immediate-release profile.
C203778	PQ/CMC Release Profile Terminology	C42730	Delayed Release Dosage Form	A solid, semi-solid, solution or suspension that has been coated with a substance that is designed to impede the immediate release of the active and/or inert ingredient(s) after administration.	Delayed-Release Profile		A design which impedes release of the drug substance for some period of time after initial administration
C203778	PQ/CMC Release Profile Terminology	C48660	Not Applicable	Determination of a value is not relevant in the current context.	Not Applicable	NA	Determination of a value is not relevant in the current context.
C203779	PQ/CMC Coating Purpose Terminology	C203884	Appearance Promoting Coating	A coating applied to promote a particular appearance of a medication.	Appearance/Identification		A coating applied to achieve a specified presentation.
C203779	PQ/CMC Coating Purpose Terminology	C203885	Consumption Promoting Coating	A coating applied to promote consumption of a medication.	Consumption Enhancement		A coating applied to facilitate swallowing (e.g., making the tablet smoother, etc.).
C203779	PQ/CMC Coating Purpose Terminology	C203886	Isolate Promoting Coating	A coating applied to isolate one or more components of a medication.	Content Isolation		A coating applied to one or more components of a tablet (e.g., beads or granules) to mitigate interaction with other components.
C203779	PQ/CMC Coating Purpose Terminology	C203887	Delayed Release Coating	A coating applied to delay the release of the medication.	Delayed Release		A coating applied to achieve a delayed release profile.
C203779	PQ/CMC Coating Purpose Terminology	C203888	Drug Layering Coating	A coating applied to define a layer(s) within a medication.	Drug Layering		A coating applied to deposit API(s) on a product or component surface (i.e., tablet, bead, blend, or other intermediates).
C203779	PQ/CMC Coating Purpose Terminology	C203889	Extended Release Coating	A coating applied to extend the release of the medication.	Extended Release		A coating applied to achieve an extended-release profile.
C203779	PQ/CMC Coating Purpose Terminology	C203890	Irritant Suppression Coating	A coating applied to suppress drug-induced irritation.	Irritant Suppression		A coating applied to reduce dispersion within the GI tract (e.g., prevention of drug-induced irritation at a specific site such as NSAIDs with an enteric coating).
C203779	PQ/CMC Coating Purpose Terminology	C203891	Odor Masking Coating	A coating applied to mask an odor.	Odor Masking		A coating applied to obscure or enhance olfaction.
C203779	PQ/CMC Coating Purpose Terminology	C203892	Protective Coating	A coating applied to protect components of a medication.	Protective		A coating applied to ensure the properties of the contents are not impacted prior to administration (e.g., by moisture, air, light, handling, transportation, etc.) and/or after administration (e.g., by inactivation of drug in the stomach such as acid-labile APIs)
C203779	PQ/CMC Coating Purpose Terminology	C203893	Seal Coating	A coating applied to seal the contents of a medication.	Seal		A coating applied to improve drug product appearance, handling, and/or stability of the dosage form, but having no measurable effect on biopharmaceutical properties of the dosage form.
C203779	PQ/CMC Coating Purpose Terminology	C203894	Site Delivery Coating	A coating applied to ensure intended delivery site of medication.	Site of Action		A coating applied to ensure delivery of API to the site of action (e.g., colon delivery).
C203779	PQ/CMC Coating Purpose Terminology	C203895	Taste Masking Coating	A coating applied to mask the taste of a medication.	Taste Masking		A coating applied to obscure or enhance gustation.
C203780	PQ/CMC Product Part Type Terminology	C202489	Dispersion Dosage Form	A substance intended for administration as a dispersion.	Dispersion		A constituent in which particles are uniformly distributed throughout a liquid.
C203780	PQ/CMC Product Part Type Terminology	C203896	Blended Dry Mixture	A medication composed of a dry mixture of ingredients.	Blend		A constituent composed of a dry mixture of ingredients (e.g., API and/or excipients) mixed in pharmaceutical processing equipment.
C203780	PQ/CMC Product Part Type Terminology	C203897	Capsule Shell	The outer coating of a capsule.	Capsule Shell		An outer skin in which a medicinal substance is contained.
C203780	PQ/CMC Product Part Type Terminology	C203898	Minitablet Dosage Form	A dosage form composed of compressed tablets with a typical diameter of 1 to 4 mm. Minitablets can in turn be processed into various formulations and/or can be used in a composite dosing form for multiparticulate dosing.	Minitablets		A constituent composed of small tablets that are filled into capsules.
C203780	PQ/CMC Product Part Type Terminology	C25450	Coat	A thin outer layer or film covering something.	Coating		A constituent composed of a thin layer covering the outer surface.
C203780	PQ/CMC Product Part Type Terminology	C42890	Bead Dosage Form	A solid in the shape of a small sphere.	Bead		A constituent composed of small sphere(s).
C203780	PQ/CMC Product Part Type Terminology	C42938	Granule Dosage Form	A solid composed of small particles or grains.	Granules		A constituent composed of dry aggregates of powder particles that may contain one or more APIs, with or without other ingredients.
C203780	PQ/CMC Product Part Type Terminology	C42986	Solution Dosage Form	A clear, homogeneous liquid composed of one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.	Solution		A constituent that is a clear, homogeneous liquid containing one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
C203780	PQ/CMC Product Part Type Terminology	C42998	Tablet Dosage Form	A solid composed of a mixture of that active and/or inert ingredient(s) are pressed or compacted together, usually in the form of a relatively flat and round, square or oval shape.	Tablet		A constituent prepared from powders or granules by compaction (with or without API and/or excipients). The tablet may be coated or uncoated.
C203780	PQ/CMC Product Part Type Terminology	C66831	Layer	A relatively thin sheetlike expanse or region lying over or under another.	Layer		A sheet, quantity, or thickness of material, typically one of several.
C96071	PQ/CMC Stability Study Reason Terminology	C115122	Generic Investigational New Animal Drug File	Data submitted to a generic investigational new animal drug file.	Generic Investigational New Animal Drug File		PQCMC data submitted to a generic investigational new animal drug file.
C96071	PQ/CMC Stability Study Reason Terminology	C115123	Abbreviated New Animal Drug Application	Data submitted to an abbreviated new animal drug application.	Abbreviated New Animal Drug Application		PQCMC data submitted to an abbreviated (generic) new animal drug application.
C96071	PQ/CMC Stability Study Reason Terminology	C70877	Drug Master File	Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.	Master File		Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They 1) Allow parties to reference material without disclosing DMF contents to those parties. 2) Are not required by statute or regulation. 3) Are neither approved nor disapproved. Instead, FDA reviews the technical contents of DMFs in connection with the review of applications that reference them (e.g., NDAs, ANDAs, INDs, BLAs).
C96071	PQ/CMC Stability Study Reason Terminology	C70880	Pre-market Approval Application	An application to FDA for a license to market a new device in the United States.	Premarket Approval		PQCMC data submitted for a PMA application.
C96071	PQ/CMC Stability Study Reason Terminology	C71778	Biologics License Application	A formal submission to FDA from any legal person or entity to obtain permission for manufacturing and marketing a biological product subject to licensure under section 351 of the Public Health Service Act. A biologics license application must contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product, sufficient for the FDA to determine that the establishment and the product meet applicable requirements to ensure the continued safety, purity, and potency of the product, including but not limited to GMPs.	Biologics License Application		PQCMC data submitted to a biologics license application.
C96071	PQ/CMC Stability Study Reason Terminology	C72899	New Drug Application	A regulatory document submitted to the FDA proposing the approval of a new drug to be marketed and sold in the U.S. It includes supporting data from both animal and human studies that was initially provided in the Investigational New Drug application (IND).	New Drug Application		PQCMC data submitted to a new human drug application.
C96071	PQ/CMC Stability Study Reason Terminology	C72901	New Animal Drug Application	Data submitted to a new animal drug application.	New Animal Drug Application		PQCMC data submitted to a new animal drug application.
C96071	PQ/CMC Stability Study Reason Terminology	C73113	Abbreviated New Drug Application	Data submitted to an abbreviated new drug application.	Abbreviated New Drug Application		PQCMC data submitted to an abbreviated (generic) new human drug application.
C96071	PQ/CMC Stability Study Reason Terminology	C80440	Humanitarian Device Exemption	A premarket submission to FDA for a device intended to benefit patients by treating or diagnosing a condition affecting fewer than 4,000 individuals in the United States per year. An HDE is similar in form and content to a premarket approval (PMA) but is exempt from the effectiveness requirements of a PMA.	Humanitarian Device Exemption (HDE)		PQCMC data submitted for an HDE application.
C96071	PQ/CMC Stability Study Reason Terminology	C80442	Premarket Device Notification	A premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective as a legally marketed device that is not subject to PMA (Premarket Authorization).	Premarket Notification 510(K)		PQCMC data submitted for a premarket 510(k) submission.
C96071	PQ/CMC Stability Study Reason Terminology	C82667	Investigational Device Exemption	Allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval application or a Premarket Notification submission to the Food and Drug Administration.	Investigational Device Exemption		PQCMC data submitted to an investigational device exemption.
C96071	PQ/CMC Stability Study Reason Terminology	C96089	Annual Report		Annual Report		PQCMC data submitted to an annual report or update to an approved application.
C96071	PQ/CMC Stability Study Reason Terminology	C96090	Investigational New Drug Application	Data submitted to an investigational new human drug application.	Investigational New Drug Application		PQCMC data submitted to an investigational new human drug application.
C96071	PQ/CMC Stability Study Reason Terminology	C96091	Investigational New Animal Drug File	Data submitted to an investigational new animal drug file.	Investigational New Animal Drug File		PQCMC data submitted to an investigational new animal drug file.
C96071	PQ/CMC Stability Study Reason Terminology	C96092	New Active Ingredient	Data submitted for an active ingredient.	New Active Ingredient		PQCMC data submitted for an active ingredient, could be PQCMC data for an active ingredient submitted in a drug application, or a Master File.
C96071	PQ/CMC Stability Study Reason Terminology	C96094	Approved Application Supplement		Supplement to an Approved Application		PQCMC data submitted to an approved application already filed with the FDA.