A	C213520	PQ/CMC Time Point Terminology	C25490	During	At some point in a given period of time.	During		In concurrence with a specified step or activity.
A	C213520	PQ/CMC Time Point Terminology	C25629	Prior	Earlier in time or order.	Before		Preceding a specified step or activity.
A	C213520	PQ/CMC Time Point Terminology	C38008	Post	Happening at a time subsequent to a reference time; later in time or order.	After		Following a specified step or activity.
A	C213644	PQ/CMC Manufacturing Site Utilization Terminology	C213645	Commercial Pharmaceutical Facility	A facility that is focused on manufacturing drug products, drug substances, or their intermediates only for marketing and distribution purposes.	Commercial		A facility that is focused on manufacturing drug products, drug substances, or their intermediates only for marketing and distribution purposes.
A	C213644	PQ/CMC Manufacturing Site Utilization Terminology	C213646	Non-commercial Pharmaceutical Facility	A facility that is focused on manufacturing drug products, drug substances, or their intermediates for development purposes.	Non-commercial		A facility that is focused on manufacturing drug products, drug substances, or their intermediates for development purposes.
A	C213644	PQ/CMC Manufacturing Site Utilization Terminology	C213647	Commercial and Non-commercial Pharmaceutical Facility	A facility that provides services to manufacture both marketable and development drug products, drug substances, or their intermediates.	Commercial and Non-commercial		A facility that provides services to manufacture both marketable and development drug products, drug substances, or their intermediates.
A	C213790	PQ/CMC Manufacturing Site Responsibility Category Terminology	C101509	API/FDF Analytical Testing Site	Sites that perform testing of the characteristics and attributes of active pharmaceutical ingredients or finished dosage forms.	Testing		A facility that provides analytic services related to the drug product, drug substance, or their intermediates. For example, release and stability testing, microbiological testing, etc.
A	C213790	PQ/CMC Manufacturing Site Responsibility Category Terminology	C214875	Drug Manufacturing Facility	A facility that makes a drug product, drug substance, or their intermediates.	Manufacturing		A facility that makes a drug product, drug substance, or their intermediates.
A	C213790	PQ/CMC Manufacturing Site Responsibility Category Terminology	C214876	Drug Packaging Facility	A facility that provides packaging services to protect the drug product, drug substance, or their intermediates against all adverse external influences that may affect its quality or potency as well as prevent leakage and spilling.	Packaging		A facility that provides packaging services to protect the drug product, drug substance, or their intermediates against all adverse external influences that may affect its quality or potency as well as prevent leakage and spilling.
A	C213790	PQ/CMC Manufacturing Site Responsibility Category Terminology	C214888	Other Site Function Facility	A facility that provides capabilities that cannot be classified under an existing manufacturing site category.	Other Site Function		A facility that provides capabilities that cannot be classified under an existing manufacturing site category.
A	C213791	PQ/CMC Manufacturing Site Responsibility Subcategory Terminology	C214877	Chemical/Physical Testing Facility	A facility that provides the capability to assess chemical/physical properties.	Chemical/Physical Testing		A facility that provides the capability to assess Chemical/Physical properties.
A	C213791	PQ/CMC Manufacturing Site Responsibility Subcategory Terminology	C214878	Microbiological Testing of Nonsterile Product Facility	A facility that provides the capability to assess microbiological content of nonsterile products.	Microbiological Testing of Nonsterile Product		A facility that provides the capability to assess microbiological content of nonsterile products.
A	C213791	PQ/CMC Manufacturing Site Responsibility Subcategory Terminology	C214879	Primary Packaging Facility	A facility that provides the capability to support primary packaging.	Primary Packaging		A facility that provides the capability to support primary packaging.
A	C213791	PQ/CMC Manufacturing Site Responsibility Subcategory Terminology	C214880	Secondary Packaging Facility	A facility that provides the capability to support secondary packaging.	Secondary Packaging		A facility that provides the capability to support secondary packaging.
A	C213791	PQ/CMC Manufacturing Site Responsibility Subcategory Terminology	C214881	Sterility Testing Facility	A facility that provides the capability to conduct sterility testing.	Sterility Testing		A facility that provides the capability to conduct sterility testing.
A	C213791	PQ/CMC Manufacturing Site Responsibility Subcategory Terminology	C214882	Biological Potency Testing Facility	A facility that provides the capability to conduct biological potency testing.	Biological Potency Testing		A facility that provides the capability to conduct biological potency testing.