A	C203345	PQ/CMC Capsule Shell Classification Terminology	C203348	Hard Gelatin Capsule Shell	A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of gelatin in which one or more drug substances and/or inert materials are enclosed.	Hard Gelatin Capsule Shell		A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of gelatin in which one or more drug substances and/or inert materials are enclosed.
A	C203345	PQ/CMC Capsule Shell Classification Terminology	C203349	Hard HPMC Capsule Shell	A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of hydroxypropyl methylcellulose (HPMC) in which one or more drug substances and/or inert materials are enclosed.	Hard HPMC Capsule Shell		A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of hydroxypropyl methylcellulose (HPMC) in which one or more drug substances and/or inert materials are enclosed.
A	C203345	PQ/CMC Capsule Shell Classification Terminology	C203350	Hard Pullulan Capsule Shell	A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of pullulan in which one or more drug substances and/or inert materials are enclosed.	Hard Pullulan Capsule Shell		A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of pullulan in which one or more drug substances and/or inert materials are enclosed.
A	C203345	PQ/CMC Capsule Shell Classification Terminology	C203351	Hard PVA Capsule Shell	A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of polyvinyl alcohol (PVA) copolymer in which one or more drug substances and/or inert materials are enclosed.	Hard PVA Capsule Shell		A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of polyvinyl alcohol (PVA) copolymer in which one or more drug substances and/or inert materials are enclosed.
A	C203345	PQ/CMC Capsule Shell Classification Terminology	C203352	Hard Starch Capsule Shell	A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of starch in which one or more drug substances and/or inert materials are enclosed.	Hard Starch Capsule Shell		A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of starch in which one or more drug substances and/or inert materials are enclosed.
A	C203345	PQ/CMC Capsule Shell Classification Terminology	C203353	Soft Gelatin Capsule Shell	A one-piece, hermetically sealed soft gelatin casing with liquid, suspension, or semisolid materials enclosed.	Soft Gelatin Capsule Shell		A one-piece, hermetically sealed soft gelatin casing with liquid, suspension, or semisolid materials enclosed.
A	C203346	PQ/CMC Release Mechanism Terminology	C203359	Matrix Drug Release	Drug release controlled by homogeneous distribution of the drug throughout a matrix. Drug molecules are released as the matrix dissolves.	Matrix		Drug release controlled by homogeneous distribution of the drug throughout a matrix. Drug molecules are released as the matrix dissolves.
A	C203346	PQ/CMC Release Mechanism Terminology	C203360	Osmotic Pump Drug Release	Drug release controlled by an osmotic agent that acts to imbibe water from the surrounding medium via a semipermeable membrane which is permeable to water but impermeable to drug. The delivery of the active agent from the device is controlled by water influx across the semipermeable membrane forcing the drug out of an orifice in the device.	Osmotic Pump		Drug release controlled by an osmotic agent that acts to imbibe water from the surrounding medium via a semipermeable membrane which is permeable to water but impermeable to drug. The delivery of the active agent from the device is controlled by water influx across the semipermeable membrane forcing the drug out of an orifice in the device.
A	C203346	PQ/CMC Release Mechanism Terminology	C203361	Reservoir Drug Release	Drug release controlled by the thickness and the dissolution rate of the encapsulating membrane surrounding the drug core.	Reservoir		Drug release controlled by the thickness and the dissolution rate of the encapsulating membrane surrounding the drug core.
A	C203347	PQ/CMC Substance Name Type Terminology	C142585	International Nonproprietary Name	A unique, internationally consistent and globally recognized name which identifies pharmaceutical substances or active pharmaceutical ingredients and is public property.	INN		International Nonproprietary Name (INN) is a unique name that is globally recognized and is public property.
A	C203347	PQ/CMC Substance Name Type Terminology	C203354	Company Identifier	An identifier assigned by a company.	Company ID/Code		An identifier or code assigned by the company.
A	C203347	PQ/CMC Substance Name Type Terminology	C203355	GSRS Preferred Term	The preferred term, preferred substance name and display name identified as PT within FDA Global Substance Registration System (GSRS).	GSRS Preferred Term		The default display name identified within FDA Global Substance Registration System (GSRS).
A	C203347	PQ/CMC Substance Name Type Terminology	C203356	IUPAC Name	A name assigned to a chemical substance according to the systematic nomenclature rules defined by the International Union of Pure and Applied Chemistry (IUPAC).	IUPAC Name		A name assigned to a chemical substance according to the systematic nomenclature rules defined by the International Union of Pure and Applied Chemistry (IUPAC).
A	C203347	PQ/CMC Substance Name Type Terminology	C203357	Chemical Systematic Name	A name derived directly from the chemical structure.	Systematic Name		A name derived directly from the chemical structure.
A	C203347	PQ/CMC Substance Name Type Terminology	C203358	USP-NF Established Name	A unique nonproprietary name assigned to drugs and biologics by the United States Pharmacopeia (USP) or excipients by the National Formulary (NF).	USP-NF Established Name		A unique nonproprietary name assigned to drugs and biologics by the United States Pharmacopeia (USP) or excipients by the National Formulary (NF).
A	C203347	PQ/CMC Substance Name Type Terminology	C54682	CAS Number	A unique numerical identifier assigned, by the Chemical Abstract Service (CAS), a division of the American Chemical Society, to chemical compounds, polymers, biological sequences, mixtures, and alloys.	CAS Number		A unique numerical identifier assigned by the Chemical Abstract Service (CAS), a division of the American Chemical Society, to chemical compounds, polymers, biological sequences, mixtures, and alloys.
A	C203347	PQ/CMC Substance Name Type Terminology	C71898	Proprietary Name	The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies.	Brand		The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies.
A	C203347	PQ/CMC Substance Name Type Terminology	C95517	ISBT-128 Donation Identification Number	A globally unique identifier that is assigned to each collection and each pooled product. The identifier is composed of four parts: a Facility Identification Number (FIN), a year of assignment, a serial number, and flag characters.	ISBT-128 DIN		A globally unique identifier that is assigned to each collection and each pooled product. The identifier is composed of four parts: a Facility Identification Number (FIN), a year of assignment, a serial number, and flag characters.
A	C203347	PQ/CMC Substance Name Type Terminology	C96973	United States Adopted Name	A unique nonproprietary name assigned to drugs and biologics by the United States Adopted Names Council (USAN).	USAN		A unique nonproprietary name assigned to drugs and biologics by the United States Adopted Names Council (USAN).
A	C203347	PQ/CMC Substance Name Type Terminology	C97054	Generic Name	A non-branded or registered name that meant for common use.	Generic Name	Common Name	
C	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.	mL	cm3 || cubic centimeter || milliliter