Subset Code	Subset Name	Concept Code	NCIt Preferred Term	NCIt Definition	PQCMC Preferred Term	PQCMC Synonyms(s)	PQCMC Definition	SPL Preferred Term	SPL Synonym (s)
C168639	PQ/CMC Application Type 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.		
C168639	PQ/CMC Application Type 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.		ANDA
C168639	PQ/CMC Application Type 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.		
C168639	PQ/CMC Application Type 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.		
C168639	PQ/CMC Application Type 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.	HUMANITARIAN DEVICE EXEMPTION	
C168639	PQ/CMC Application Type 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.		
C168639	PQ/CMC Application Type 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.		
C168639	PQ/CMC Application Type 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.		
C168639	PQ/CMC Application Type 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.		
C168639	PQ/CMC Application Type 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.		
C168639	PQ/CMC Application Type 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.	New Drug Application	
C168639	PQ/CMC Application Type 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.		
C168639	PQ/CMC Application Type 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.	PREMARKET NOTIFICATION	510(k)
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	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	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	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.		
C133847	PQ/CMC Chemical Structure Data File Origin Terminology	C16275	Algorithm	A defined procedure for solving a problem. Applied to a problem-solving procedure implemented in software to be executed by a computer.	Calculated		A defined procedure for solving a problem. Applied to a problem-solving procedure implemented in software to be executed by a computer.		
C133847	PQ/CMC Chemical Structure Data File Origin Terminology	C133995	Experimentally Determined Chemical Structure	Chemical structure derived from an investigative process using instrumentation.	Experimental		Chemical structure derived from an investigative process using instrumentation.		
C133847	PQ/CMC Chemical Structure Data File Origin 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.		
C133847	PQ/CMC Chemical Structure Data File Origin 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.		
C133847	PQ/CMC Chemical Structure Data File Origin Terminology	C133910	MDL 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.	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.		
C133847	PQ/CMC Chemical Structure Data File Origin 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.		
C133847	PQ/CMC Chemical Structure Data File Origin Terminology	C133996	MDL Structure-data File	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.		
C133847	PQ/CMC Chemical Structure Data File Origin 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	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	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	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	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	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	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	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	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	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	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	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	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.		
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	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	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	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	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.		
C133850	PQ/CMC Compendial Method Verification Indicator Terminology	C49487	No	The non-affirmative response to a question.	No		The non-affirmative response to a question.		
C133850	PQ/CMC Compendial Method Verification Indicator Terminology	C49488	Yes	The affirmative response to a question.	Yes		The affirmative response to a question.		
C133851	PQ/CMC Conformance to Criteria Terminology	C80262	Conformance	Correspondence in form or appearance.	Conforms		Correspondence in form or appearance.		
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.		
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	C133999	Inverted	To place upside down.	Inverted		To place upside down.		
C133852	PQ/CMC Container Orientation Terminology	C86043	Upright	In a vertical position or posture.	Upright		In a vertical position or posture.		
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	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.		
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.	AMPULE	
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.	APPLICATOR	
C133853	PQ/CMC Container Type Terminology	C43167	Bag	A sac or pouch.	BAG		A sac or pouch.	BAG	
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.	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.	BOTTLE	
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.	BOTTLE, DISPENSING	
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).	BOTTLE, DROPPER	
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.	BOTTLE, GLASS	
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.	BOTTLE, PLASTIC	
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.	BOTTLE, PUMP	
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.	BOTTLE, SPRAY	
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.	BOTTLE, UNIT-DOSE	
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.	BOTTLE, WITH APPLICATOR	
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.	BOX	
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.]	Box, Unit-Dose	
C133853	PQ/CMC Container Type Terminology	C43180	Can	A cylindrical vessel, usually made of metal.	CAN		A cylindrical vessel, usually made of metal.	CAN	
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.	CANISTER	
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	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.	CAPSULE	
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.	CARTON	
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.	CARTRIDGE	
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).	CASE	
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].	CELLO PACK	
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.	CONTAINER	
C133853	PQ/CMC Container Type Terminology	C43187	Cup	A bowl-shaped container.	CUP		A bowl-shaped container.	CUP	
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.	CUP, UNIT-DOSE	
C133853	PQ/CMC Container Type Terminology	C43189	Gas Cylinder	A container designed specifically to hold gases.	CYLINDER		A container designed specifically to hold gases.	CYLINDER	
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').	DEWAR	
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.	DIALPACK	
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	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.	DOSE PACK	
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.	DRUM	
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.		
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.	FLEXIBLE INTERMEDIATE BULK CONTAINER	
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.	INHALER	
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.	INHALER, REFILL	
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.	JAR	
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.	JUG	
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.	KIT	
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.	NOT STATED	
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.	PACKAGE	
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.	PACKAGE, COMBINATION	
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.	PACKET	
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.	PAIL	
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.	PATCH	
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	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).	POUCH	
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.	SUPERSACK	
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.	SYRINGE	
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.	SYRINGE, GLASS	
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.	SYRINGE, PLASTIC	
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.	TABMINDER	
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.	TANK	
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.	TRAY	
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.	TUBE	
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.	TUBE, WITH APPLICATOR	
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.	VIAL	
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.	VIAL, DISPENSING	
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.	VIAL, GLASS	
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.	VIAL, MULTI-DOSE	
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.	VIAL, PATENT 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.	VIAL, PHARMACY BULK PACKAGE	
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.	VIAL, PIGGYBACK	
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.	VIAL, PLASTIC	
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.	VIAL, SINGLE-DOSE	
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.	VIAL, SINGLE-USE	
C133855	PQ/CMC Drug Substance Product Indicator Terminology	C1909	Pharmacologic Substance	Any natural, endogenously-derived, synthetic or semi-synthetic compound with pharmacologic activity. A pharmacologic substance has one or more specific mechanism of action(s) through which it exerts one or more effect(s) on the human or animal body. They can be used to potentially prevent, diagnose, treat or relieve symptoms of a disease. Formulation specific agents and some combination agents are also classified as pharmacologic substances.	Product		Any natural, endogenously-derived, synthetic or semi-synthetic compound with pharmacologic activity. A pharmacologic substance has one or more specific mechanism of action(s) through which it exerts one or more effect(s) on the human or animal body. They can be used to potentially prevent, diagnose, treat or relieve symptoms of a disease. Formulation specific agents and some combination agents are also classified as pharmacologic substances.		
C133855	PQ/CMC Drug Substance Product Indicator Terminology	C45306	Substance	Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical.	SUBSTANCE		Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical.	SUBSTANCE	
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 Impurities		Any unwanted inorganic compound generated during the manufacturing process of a particular substance or product.		
C133856	PQ/CMC Impurity Classification Terminology	C134000	Organic Impurity	Any unwanted organic compound that is present in specifically defined substances or products and is generated during the manufacturing process or is created upon degradation during storage.	Organic Impurities (process- and product-related)		Any unwanted organic compound that is present in specifically defined substances or products and is generated during the manufacturing process or is created upon degradation during storage.		
C133858	PQ/CMC Interpretation Code 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 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 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 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 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.		
C133858	PQ/CMC Interpretation Code 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.		
C133859	PQ/CMC Manufacturing Site Unique 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).		
C133859	PQ/CMC Manufacturing Site Unique 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.		
C133859	PQ/CMC Manufacturing Site Unique 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.		
C133859	PQ/CMC Manufacturing Site Unique Identifier Type Terminology	C17998	Unknown	Not known, not observed, not recorded, or refused.	Unknown		Not known, not observed, not recorded, or refused.		
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	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.		
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	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	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)		
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.	Approved	
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.		
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	C134010	Tentative Approval	Provisional approval of a specification.	Tentatively Approved		Provisional approval of a specification.		
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.		
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.		
C168624	PQ/CMC Sponsor 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 Sponsor 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 Sponsor 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 Sponsor Identifier Type Terminology	C17998	Unknown	Not known, not observed, not recorded, or refused.	Unknown		Not known, not observed, not recorded, or refused.		
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	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	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	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	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.		
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.		
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.		
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.		
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.		
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	C17771	Chemical Properties	General term for compositional, structural, and reactivity- affecting qualities of chemical compounds.	Chemical Properties		A characteristic of a material that is observed during a reaction in which the chemical composition or identity of the material is changed (e.g., combustibility, solubility, acidity/basicity).		
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	C158424	Physical Property	Any of the characteristics that define the nature of matter or forces that act upon it.	Physical 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.		
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.		
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.		
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.