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 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 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 Capsule shell 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. 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 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 C17998 Unknown Not known, observed, recorded; or reported as unknown by the data contributor. Unknown Not known, not observed, not recorded, or refused. 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. C133869 PQ/CMC Testing 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. C133869 PQ/CMC Testing 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. C133869 PQ/CMC Testing 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). C133869 PQ/CMC Testing Site Unique 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. 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 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 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 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). C176676 PQ/CMC Excipient Function 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 Capsule shell 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. 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. cm3 || mL cubic centimeter || mililiter || 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 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 C64559 Atomic Mass Unit A small unit of mass used to express atomic and molecular masses. u atomic mass unit 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. C185183 PQ/CMC Retest 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". C185183 PQ/CMC Retest 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. C185183 PQ/CMC Retest 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". C185183 PQ/CMC Retest 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. 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.