PQ/CMC Terminology Files

The NCIt-Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) terminology files provided here support the cooperative efforts of the Food and Drug Administration (FDA) and the National Cancer Institute's Thesaurus (NCIt) to develop terminology that facilitates the processing and review of Pharmaceutical Quality/CMC Terminology Files data. The efforts are described more fully on the Pharmaceutical Quality/CMC github web page. PQ/CMC terminology files are available for download from this NCI EVS ftp site (http://evs.nci.nih.gov/ftp1/FDA/PQCMC/) in three formats:

PQCMC_NCIt_Subsets.xls
PQCMC_NCIt_Subsets.txt
PQCMC_NCIt_Subsets.xml

Additionally, PQ/CMC has added two previously created subsets to their project:
SPL Pharmaceutical Dosage Form Terminology
NCIt-GENC_Terminology.xlsx

For more information about SPL, visit About SPL
For more information about GENC, visit About GENC

The PQCMC spreadsheet has two tabs of data; on the first tab are the following column headers:

Spreadsheet Column	Content Description
Subset Code	The NCIt concept code attached to the subset concept. NCIt Codes are unique strings that begin with a C and are followed by a series of digits.
Subset Name	The name of the subset.
Concept Code	The NCIt concept code attached to the PT concept.
NCIt Preferred Term	The preferred term chosen by NCI EVS for the concept.
NCIt Definition	The NCI EVS definition for the term.
PQCMC Preferred Term	The preferred term chosen by the PQ/CMC group attached to the concept.
PQCMC Synonym(s)	Terms chosen by the PQ/CMC group that are synonomous to the Preferred Term.
PQCMC Definition	A text definition of the term created by the PQ/CMC group.

PQ/CMC terminology is bundled into subsets, identified by code and name in the first and second columns of each row. These are the names and definitions of the subsets.

Subset Name Subset Description

PQ/CMC Application Submission Type Terminology Terminology used to qualify the information pertaining to application submission types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Application Type Terminology Terminology used to qualify the information pertaining to application types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Batch Utilization Terminology Terminology used to qualify the information pertaining to batch utilization in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Chemical Structure Data File Origin Terminology Terminology used to qualify the information pertaining to chemical structure data file origins in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Chemical Structure Data File Type Terminology Terminology used to qualify the information pertaining to chemical structure data file types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Closure Type Terminology Terminology used to qualify the information pertaining to closure types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Co-Packaged Indicator Terminology Terminology used to qualify the information pertaining to co-packaged indicators in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Compendial Method Verification Indicators Terminology Terminology used to qualify the information pertaining to compendial method verification indicators in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Conformance to Criteria Terminology Terminology used to qualify the information pertaining to conformance to criteria in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Container Orientation Terminology Terminology used to qualify the information pertaining to container orientation in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Container Type Terminology Terminology used to qualify the information pertaining to container types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Drug Product Component Function Category Terminology Terminology used to qualify the information pertaining to drug product component function categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Drug Substance Product Indicator Terminology Terminology used to qualify the information pertaining to drug substance product indicators in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Excipient Function Terminology Terminology used to qualify the information pertaining to excipient functions in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Impurity Classification Terminology Terminology used to qualify the information pertaining to impurity classifications in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Interpretation Code (numeric) Terminology Terminology used to qualify the information pertaining to numeric interpretation codes in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Interpretation Code (text) Terminology Terminology used to qualify the information pertaining to textual interpretation codes in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Manufacturing Site Unique Identifier Terminology Terminology used to qualify the information pertaining to manufacturing site unique identifiers in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Process Related Impurity Category Terminology Terminology used to qualify the information pertaining to process related impurity categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Product Related Impurity Category Terminology Terminology used to qualify the information pertaining to product related impurity categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Quality Benchmark Terminology Terminology used to qualify the information pertaining to quality benchmarks in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Source Type Terminology Terminology used to qualify the information pertaining to source types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Specification Status Terminology Terminology used to qualify the information pertaining to specification statuses in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Specification Type Terminology Terminology used to qualify the information pertaining to specification types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Sponsor Identifier Type Terminology Terminology used to qualify the information pertaining to sponsor identifier types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Storage Conditions Terminology Terminology used to qualify the information pertaining to storage conditions in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Strength Operator Terminology Terminology used to qualify the information pertaining to strength operators in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Strength Type Terminology Terminology used to qualify the information pertaining to strength types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Test Category Terminology Terminology used to qualify the information pertaining to test categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Test Method Origin Terminology Terminology used to qualify the information pertaining to test method origins in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Test Usage Terminology Terminology used to qualify the information pertaining to test usage in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Testing Site Unique Identifier Type Terminology Terminology used to qualify the information pertaining to testing site unique identifier types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Units of Measure Terminology Terminology used to qualify the information pertaining to units of measure in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

PQ/CMC Validation Parameter Terminology Terminology used to qualify the information pertaining to validation parameters in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

SPL Pharmaceutical Dosage Form Terminology Terminology used for representation of the information on pharmaceutical product dosage form in the framework of the SPL documents.

Subset Name	Subset Description
PQ/CMC Application Submission Type Terminology	Terminology used to qualify the information pertaining to application submission types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Application Type Terminology	Terminology used to qualify the information pertaining to application types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Batch Utilization Terminology	Terminology used to qualify the information pertaining to batch utilization in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Chemical Structure Data File Origin Terminology	Terminology used to qualify the information pertaining to chemical structure data file origins in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Chemical Structure Data File Type Terminology	Terminology used to qualify the information pertaining to chemical structure data file types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Closure Type Terminology	Terminology used to qualify the information pertaining to closure types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Co-Packaged Indicator Terminology	Terminology used to qualify the information pertaining to co-packaged indicators in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Compendial Method Verification Indicators Terminology	Terminology used to qualify the information pertaining to compendial method verification indicators in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Conformance to Criteria Terminology	Terminology used to qualify the information pertaining to conformance to criteria in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Container Orientation Terminology	Terminology used to qualify the information pertaining to container orientation in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Container Type Terminology	Terminology used to qualify the information pertaining to container types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Drug Product Component Function Category Terminology	Terminology used to qualify the information pertaining to drug product component function categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Drug Substance Product Indicator Terminology	Terminology used to qualify the information pertaining to drug substance product indicators in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Excipient Function Terminology	Terminology used to qualify the information pertaining to excipient functions in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Impurity Classification Terminology	Terminology used to qualify the information pertaining to impurity classifications in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Interpretation Code (numeric) Terminology	Terminology used to qualify the information pertaining to numeric interpretation codes in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Interpretation Code (text) Terminology	Terminology used to qualify the information pertaining to textual interpretation codes in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Manufacturing Site Unique Identifier Terminology	Terminology used to qualify the information pertaining to manufacturing site unique identifiers in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Process Related Impurity Category Terminology	Terminology used to qualify the information pertaining to process related impurity categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Product Related Impurity Category Terminology	Terminology used to qualify the information pertaining to product related impurity categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Quality Benchmark Terminology	Terminology used to qualify the information pertaining to quality benchmarks in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Source Type Terminology	Terminology used to qualify the information pertaining to source types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Specification Status Terminology	Terminology used to qualify the information pertaining to specification statuses in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Specification Type Terminology	Terminology used to qualify the information pertaining to specification types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Sponsor Identifier Type Terminology	Terminology used to qualify the information pertaining to sponsor identifier types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Storage Conditions Terminology	Terminology used to qualify the information pertaining to storage conditions in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Strength Operator Terminology	Terminology used to qualify the information pertaining to strength operators in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Strength Type Terminology	Terminology used to qualify the information pertaining to strength types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Test Category Terminology	Terminology used to qualify the information pertaining to test categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Test Method Origin Terminology	Terminology used to qualify the information pertaining to test method origins in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Test Usage Terminology	Terminology used to qualify the information pertaining to test usage in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Testing Site Unique Identifier Type Terminology	Terminology used to qualify the information pertaining to testing site unique identifier types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Units of Measure Terminology	Terminology used to qualify the information pertaining to units of measure in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
PQ/CMC Validation Parameter Terminology	Terminology used to qualify the information pertaining to validation parameters in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
SPL Pharmaceutical Dosage Form Terminology	Terminology used for representation of the information on pharmaceutical product dosage form in the framework of the SPL documents.

Also included on the NCI EVS ftp site (http://evs.nci.nih.gov/ftp1/FDA/PQCMC/) are the following additional files:

About (This file)
Changes.txt (A text file of changes between the most recent and the current version of the PQCMC terminology. For each change record, the Changes.txt contains a complete row of tab delimited data with the same data elements as described above. An "A" will precede any new concept additions, a "C" will precede any modification to existing concepts, and a "D" will precede any concepts that have been deleted.)
Version.txt (A text file that contains the version of NCI Thesaurus that corresponds to the current spreadsheet data. The database is reconciled the last Monday of every month. The files will be posted during the following two weeks. The version appears as YR.MOweek. An example is 20.02d which corresponds to the year 2020, the month of February, and the "d" refers to the fourth Monday of the month.)

Archived files are available at:

Archive/ Directory of dated release versions.
Help requests on these files should go to NCIThesaurus@mail.nih.gov