A	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.
A	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.
A	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.
A	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.
A	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)]
A	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]
A	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)]
A	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]
A	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.
A	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".
A	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.
A	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".
A	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".
A	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.
A	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".
A	C185189	PQ/CMC Interval Description Code Terminology	C96150	Immediate Testing	Sample is tested immediately.	Immediate Testing		Sample is tested immediately.
A	C185189	PQ/CMC Interval Description Code Terminology	C96151	Delayed Testing	Sample is not tested immediately.	Delayed Testing		Sample is not tested immediately.
A	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.
A	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.
A	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.
C	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.
C	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		
C	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.
C	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.
C	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		
C	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.
C	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	
C	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).
C	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.
C	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.
C	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]
C	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.
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.
C	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.
C	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.
C	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.
C	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.
C	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.
C	C133870	PQ/CMC Validation Parameter Terminology	C134032	Analyte Specificity	The ability to assess unequivocally the analyte in the presence of other components which may be expected to be present.	Specificity		The ability to assess unequivocally the analyte in the presence of other components which may be expected to be present.
C	C133870	PQ/CMC Validation Parameter Terminology	C134033	Analytical Procedure Linearity	The ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in a sample.	Linearity		The ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in a sample.
C	C133870	PQ/CMC Validation Parameter Terminology	C134240	Analytical Procedure Range	The interval between the upper and lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity.	Range		The interval between the upper and lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity.
C	C133870	PQ/CMC Validation Parameter Terminology	C134242	Analytical Procedure Accuracy	The closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found.	Accuracy		The closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found.
C	C133870	PQ/CMC Validation Parameter Terminology	C134243	Analytical Procedure Precision	The closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions. Precision may be considered at three levels: repeatability, intermediate precision and reproducibility.	Precision		The closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions. Precision may be considered at three levels: repeatability, intermediate precision and reproducibility.
C	C133870	PQ/CMC Validation Parameter Terminology	C134244	Analytical Procedure Detection Limit	The lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value.	Detection Limit		The lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value.
C	C133870	PQ/CMC Validation Parameter Terminology	C134245	Analytical Procedure Robustness	The measure of a procedure's capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage.	Robustness		The measure of a procedure's capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage.
C	C133870	PQ/CMC Validation Parameter Terminology	C134246	System Suitability	The tests are based on the concept that the equipment, electronics, analytical operations, and samples to be analyzed constitute an integral system that can be evaluated as such. System suitability test parameters to be established for a particular procedure depend on the type of procedure being validated.	System Suitability		The tests are based on the concept that the equipment, electronics, analytical operations, and samples to be analyzed constitute an integral system that can be evaluated as such. System suitability test parameters to be established for a particular procedure depend on the type of procedure being validated.
C	C133870	PQ/CMC Validation Parameter Terminology	C134248	Analytical Procedure Quantitation Limit	The lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy.	Quantitation Limit		The lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy.
C	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)
D	C133856	PQ/CMC Impurity Classification Terminology	C84280	Contaminant	A substance that makes a material impure.	Contaminants		Contaminants in a product include all adventitiously introduced materials not intended to be part of the manufacturing process, such as chemical and biochemical materials, and/or microbial species.  Examples:  bisphenol-A diglycidyl ether (BADGE), bisphenol A (BPA,  isopropyl acetophenone,  microbial proteases, endotoxin, etc.
D	C176790	PQ/CMC Process Related Impurity Category Terminology	C134000	Organic Impurity	Any unwanted organic compound that is present in specifically defined substances or products and is generated during the manufacturing process or is created upon degradation during storage.	Organic		Materials that are degradation products or residuals and are generated during a manufacturing process or storage. [Source: Adapted form ICH Q3A(R2)]
D	C176790	PQ/CMC Process Related Impurity Category 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.
D	C176790	PQ/CMC Process Related Impurity Category 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)]
D	C176814	PQ/CMC Product Related Impurity Category 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.
D	C176814	PQ/CMC Product Related Impurity Category Terminology	C176816	Degradant	An impurity resulting from a chemical change in the drug substance.	Degradants		An impurity resulting from a chemical change in the drug substance [Source: Adapted from ICH Q3B(R2)] Example:  Aggregates, Truncated Form,  etc.