D	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.
D	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.
D	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.
D	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.
D	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.
D	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.
D	C133855	PQ/CMC Drug Substance Product Indicator Terminology	C1909	Pharmacologic Substance	Any natural, endogenously-derived, synthetic or semi-synthetic compound with pharmacologic activity. A pharmacologic substance has one or more specific mechanism of action(s) through which it exerts one or more effect(s) on the human or animal body. They can be used to potentially prevent, diagnose, treat or relieve symptoms of a disease. Formulation specific agents and some combination agents are also classified as pharmacologic substances.	Product		Any natural, endogenously-derived, synthetic or semi-synthetic compound with pharmacologic activity. A pharmacologic substance has one or more specific mechanism of action(s) through which it exerts one or more effect(s) on the human or animal body. They can be used to potentially prevent, diagnose, treat or relieve symptoms of a disease. Formulation specific agents and some combination agents are also classified as pharmacologic substances.
D	C133855	PQ/CMC Drug Substance Product Indicator Terminology	C45306	Substance	Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical.	SUBSTANCE		Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical.
D	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.
D	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.
D	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.
D	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.
D	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.
D	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.
D	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.
D	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.
D	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.
D	C176788	PQ/CMC Application Submission Type Terminology	C176796	Amendment to Original Submission	Amendment submission to the original submission as submitted by the sponsor to a regulatory agency.	Amendment to Original		Amendment submission to the original submission as submitted by the sponsor.
D	C176788	PQ/CMC Application Submission Type Terminology	C176797	Supplement to Original Submission	Supplement submission to the original as submitted by the sponsor to the regulatory agency.	Supplement to Original		Supplement submission to the original as submitted by the sponsor.
D	C176788	PQ/CMC Application Submission Type Terminology	C176798	Amendment to Supplement Submission	Amendment submission to the supplement of the original submission as submitted by the sponsor to the regulatory agency.	Amendment to Supplement		Amendment submission to the supplement of the original submission as submitted by the sponsor.
D	C176788	PQ/CMC Application Submission Type Terminology	C176802	Amendment to Investigational New Drug	An amendment to the Investigational New Drug submission as submitted by the sponsor.	Amendment to INDs		Amendment to the INDs as submitted by the sponsor.
D	C176788	PQ/CMC Application Submission Type Terminology	C176803	Amendment to Master Drug File	Amendment submission to the Master Drug File submission as submitted by the sponsor.	Amendment to Master Files		Amendment submission to the Master Files submission as submitted by the sponsor.
D	C176788	PQ/CMC Application Submission Type Terminology	C70860	Original Regulatory Submission	Original submission type as submitted by the sponsor to a regulatory agency.	Original		Original submission type as submitted by the sponsor.
D	C133850	PQ/CMC Compendial Method Verification Indicator Terminology	C49487	No	The non-affirmative response to a question.	No		The non-affirmative response to a question.
D	C133850	PQ/CMC Compendial Method Verification Indicator Terminology	C49488	Yes	The affirmative response to a question.	Yes		The affirmative response to a question.
D	C133857	PQ/CMC Interpretation Code (text) 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.
D	C168639	PQ/CMC Application Type Terminology	C115122	Generic Investigational New Animal Drug File	Data submitted to a generic investigational new animal drug file.	Generic Investigational New Animal Drug File		PQCMC data submitted to a generic investigational new animal drug file.
D	C168639	PQ/CMC Application Type Terminology	C115123	Abbreviated New Animal Drug Application	Data submitted to an abbreviated new animal drug application.	Abbreviated New Animal Drug Application		PQCMC data submitted to an abbreviated (generic) new animal drug application.
D	C168639	PQ/CMC Application Type 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).
D	C168639	PQ/CMC Application Type Terminology	C70880	Pre-market Approval Application	An application to FDA for a license to market a new device in the United States.	Premarket Approval		PQCMC data submitted for a PMA application.
D	C168639	PQ/CMC Application Type Terminology	C71778	Biologics License Application	A formal submission to FDA from any legal person or entity to obtain permission for manufacturing and marketing a biological product subject to licensure under section 351 of the Public Health Service Act. A biologics license application must contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product, sufficient for the FDA to determine that the establishment and the product meet applicable requirements to ensure the continued safety, purity, and potency of the product, including but not limited to GMPs.	Biologics License Application		PQCMC data submitted to a biologics license application.
D	C168639	PQ/CMC Application Type Terminology	C72899	New Drug Application	A regulatory document submitted to the FDA proposing the approval of a new drug to be marketed and sold in the U.S. It includes supporting data from both animal and human studies that was initially provided in the Investigational New Drug application (IND).	New Drug Application		PQCMC data submitted to a new human drug application.
D	C168639	PQ/CMC Application Type Terminology	C72901	New Animal Drug Application	Data submitted to a new animal drug application.	New Animal Drug Application		PQCMC data submitted to a new animal drug application.
D	C168639	PQ/CMC Application Type Terminology	C73113	Abbreviated New Drug Application	Data submitted to an abbreviated new drug application.	Abbreviated New Drug Application		PQCMC data submitted to an abbreviated (generic) new human drug application.
D	C168639	PQ/CMC Application Type Terminology	C80440	Humanitarian Device Exemption	A premarket submission to FDA for a device intended to benefit patients by treating or diagnosing a condition affecting fewer than 4,000 individuals in the United States per year. An HDE is similar in form and content to a premarket approval (PMA) but is exempt from the effectiveness requirements of a PMA.	Humanitarian Device Exemption (HDE)		PQCMC data submitted for an HDE application.
D	C168639	PQ/CMC Application Type Terminology	C80442	Premarket Device Notification	A premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective as a legally marketed device that is not subject to PMA (Premarket Authorization).	Premarket Notification 510(K)		PQCMC data submitted for a premarket 510(k) submission.
D	C168639	PQ/CMC Application Type Terminology	C82667	Investigational Device Exemption	Allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval application or a Premarket Notification submission to the Food and Drug Administration.	Investigational Device Exemption		PQCMC data submitted to an investigational device exemption.
D	C168639	PQ/CMC Application Type Terminology	C96090	Investigational New Drug Application	Data submitted to an investigational new human drug application.	Investigational New Drug Application		PQCMC data submitted to an investigational new human drug application.
D	C168639	PQ/CMC Application Type Terminology	C96091	Investigational New Animal Drug File	Data submitted to an investigational new animal drug file.	Investigational New Animal Drug File		PQCMC data submitted to an investigational new animal drug file.
D	C168639	PQ/CMC Application Type Terminology	C96092	New Active Ingredient	Data submitted for an active ingredient.	New Active Ingredient		PQCMC data submitted for an active ingredient, could be PQCMC data for an active ingredient submitted in a drug application, or a Master File.
D	C176788	PQ/CMC Application Submission Type Terminology	C176796	Amendment to Original Submission	Amendment submission to the original submission as submitted by the sponsor to a regulatory agency.	Amendment to Original		Amendment submission to the original submission as submitted by the sponsor.
D	C176788	PQ/CMC Application Submission Type Terminology	C176797	Supplement to Original Submission	Supplement submission to the original as submitted by the sponsor to the regulatory agency.	Supplement to Original		Supplement submission to the original as submitted by the sponsor.
D	C176788	PQ/CMC Application Submission Type Terminology	C176798	Amendment to Supplement Submission	Amendment submission to the supplement of the original submission as submitted by the sponsor to the regulatory agency.	Amendment to Supplement		Amendment submission to the supplement of the original submission as submitted by the sponsor.
D	C176788	PQ/CMC Application Submission Type Terminology	C176802	Amendment to Investigational New Drug	An amendment to the Investigational New Drug submission as submitted by the sponsor.	Amendment to INDs		Amendment to the INDs as submitted by the sponsor.
D	C176788	PQ/CMC Application Submission Type Terminology	C176803	Amendment to Master Drug File	Amendment submission to the Master Drug File submission as submitted by the sponsor.	Amendment to Master Files		Amendment submission to the Master Files submission as submitted by the sponsor.
D	C176788	PQ/CMC Application Submission Type Terminology	C70860	Original Regulatory Submission	Original submission type as submitted by the sponsor to a regulatory agency.	Original		Original submission type as submitted by the sponsor.
A	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.
A	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.
A	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).
A	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.
A	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.
A	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.
A	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.
A	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.
A	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.
A	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.
A	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.
A	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.
A	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.
A	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.
A	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.
A	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.