A	C133807	PQ/CMC Test Category Terminology	C103201	Optical Rotation	The ability of a chiral substance to rotate the plane of polarization of a beam of transmitted plane-polarized light, either clockwise (to the right) or counterclockwise (to the left).	Optical Rotation		A property of many pharmaceutical substances to rotate an incident plane of polarized light so that the transmitted light emerges at a measurable angle to the plane of the incident light.
A	C133807	PQ/CMC Test Category Terminology	C133961	Deliverable Volume/Fill Volume Test	Tests designed to provide assurance that the liquids will, when transferred from the original container, deliver the volume of dosage form that is declared on the label of the article.	Deliverable Volume/Fill Volume		Tests designed to provide assurance that oral liquids will, when transferred from the original container, deliver the volume of dosage form that is declared on the label of the article.
A	C133807	PQ/CMC Test Category Terminology	C133974	Crystallinity Analysis	The detection and quantification of the amount of amorphous material within a highly crystalline substance.	Crystallinity		The detection and/or quantification of the amount of amorphous material within a highly crystalline substance.
A	C133807	PQ/CMC Test Category Terminology	C133975	Tablet Friability Determination	The percent loss of a tablet due to mechanical action that results in fracture or breaking during the test.	Friability		The percent loss of a tablet due to mechanical action that results in fracture or breaking during the test
A	C133807	PQ/CMC Test Category Terminology	C133979	Viscosity/Rheological Property Analysis	The determination of the thickness of a fluid and other properties related to the flow of a material.	Viscosity/Rheological Properties		Tests to measure a property of liquids that is closely related to the resistance to flow.
A	C133807	PQ/CMC Test Category Terminology	C133983	Pyrogenicity/Endotoxin Assessment	Tests to measure the ability of a substance to produce an endotoxin or febrile and/or inflammatory reaction in response to administration of a substance.	Pyrogenicity/Endotoxin		Tests designed to limit to an acceptable level the risks of febrile reaction in the patient to the administration, by injection, of the product concerned. The test involves measuring the rise in temperature of rabbits following the intravenous injection of a test solution and is designed for products that can be tolerated by the test rabbit in a dose not to exceed 10 mL/kg injected intravenously within a period of NMT 10 min.
A	C133807	PQ/CMC Test Category Terminology	C133985	Redispersibility Measurement	A measurement of the time necessary for settled components to remix uniformly.	Redispersibility		Testing of oral suspensions that settle on storage (produce sediment) to measure the time required to achieve resuspension.
A	C133807	PQ/CMC Test Category Terminology	C134113	Syringe Functionality Testing	Testing a syringe to verify it functions properly.	Syringe Functionality		Tests performed on syringes to ensure that It operates as specified.
A	C133807	PQ/CMC Test Category Terminology	C134114	Total Organic Carbon Measurement	An indirect measure of organic molecules present in pharmaceutical waters measured as carbon.	Total Organic Carbon		An indirect measure of organic molecules present in pharmaceutical waters measured as carbon.
A	C133807	PQ/CMC Test Category Terminology	C134249	Container Closure Integrity Testing	An assessment of the structural characteristics of the container closure system to ensure the required specifications for integrity are met.	Container Closure Integrity		Tests for the adequacy of pharmaceutical packaging and container closures.
A	C133807	PQ/CMC Test Category Terminology	C134250	Content Uniformity Test	An assessment of the quality of the sameness of the contents of a substance.	Uniformity		Tests to ensure the consistency of the API in the formulation. Test may be done as an IPC, release, or stability test.
A	C133807	PQ/CMC Test Category Terminology	C134252	Pharmaceutical Disintegration Test	Test to determine whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium at the experimental conditions.	Disintegration		Test to determine whether tablets capsules disintegrate within the prescribed time when placed in a liquid medium at the experimental conditions.
A	C133807	PQ/CMC Test Category Terminology	C134253	Pharmaceutical Dissolution Test	Test to determine compliance with the requirements of the material of interest dissolving into solution.	Dissolution		Test to determine compliance with the requirements of the material of interest dissolving into solution.
A	C133807	PQ/CMC Test Category Terminology	C134255	Loss on Drying Measurement	The determination of the total change in weight of a material as a result of drying. It determines the moisture content of a sample	Loss on Drying		Analytical procedures to determine the amount of volatile matter of any kind that is driven off under the conditions specified.
A	C133807	PQ/CMC Test Category Terminology	C134256	Microbial Limit Determination	An assessment of the total number of viable aerobic microorganisms present in a product and the semi-quantitative estimation of the relative number of specific types of microbes present based on an established specification for production quality.	Microbial Limits		Tests for the estimation of the number of viable aerobic microorganisms present and for the freedom from designated microbial species in the pharmaceutical articles of all kinds, from raw materials to the finished forms.
A	C133807	PQ/CMC Test Category Terminology	C134257	Particle Size Distribution Analysis	Analytical procedures that utilize mechanical sieving for deducing the particle-size distribution of a powdered solid.	Particle Size Distribution		Analytical procedures that utilize mechanical sieving for deducing the particle-size distribution of a powdered solid.
A	C133807	PQ/CMC Test Category Terminology	C134260	Powder Bulk Density Measurement	The ratio of the mass of an untapped powder sample and its volume including the contribution of the interparticulate void volume.	Bulk Density		Tests that determine the ratio of the mass of an untapped powder sample and its volume including the contribution of the interparticulate void volume.
A	C133807	PQ/CMC Test Category Terminology	C134263	Conductivity Measurement	A measure of the ion-facilitated electron current through a material.	Conductivity		Electrical conductivity is a measure of the ion-facilitated electron flow through it.
A	C133807	PQ/CMC Test Category Terminology	C134264	Hardness Measurement	The determination of the breaking point and structural integrity of a material.	Hardness		A test used to identify the ability of a material to resist mechanical deformation such as scratching or penetration by other substances.
A	C133807	PQ/CMC Test Category Terminology	C134266	Tap Density Determination	Determination of the density, compared to the bulk density, of dry particles, expressed in mass/volume, obtained by mechanically tapping a cylinder containing the powder sample until no more change in volume occurs.	Tap Density		An increased bulk density attained after mechanically tapping the container containing the powder sample. (aka - tapped density)
A	C133807	PQ/CMC Test Category Terminology	C134267	Plume Geometry Test	A test that measures the spray pattern characteristics, including shape and size of the evolving spray cloud under defined experimental and instrumental test conditions.	Plume Geometry		A test that measures the spray pattern characteristics, including shape and size of the evolving spray cloud under defined experimental and instrumental test conditions.
A	C133807	PQ/CMC Test Category Terminology	C134269	Polymorphic Form Determination	Tests to determine the crystalline form of a particular solid material.	Polymorphism		Tests to determine the different crystalline forms of a given drug substance
A	C133807	PQ/CMC Test Category Terminology	C134270	Potency Assay	The determination of the strength of a material, as measured by the ability to produce a specific response. The potency of a pharmacologic substance is measured by the amount needed to produce a certain effect.	Potency		Tests to measure the biological activity using a suitably quantitative biological assay (also called potency assay or bioassay), based on the attribute of the product which is linked to the relevant biological properties.
A	C133807	PQ/CMC Test Category Terminology	C134272	Reconstitution Time Measurement	Measurement of how long it takes to restore something dried to its original state of liquid.	Reconstitution Time		Measurement of how long it takes to restore something dried to its original state of liquid.
A	C133807	PQ/CMC Test Category Terminology	C134276	Residue on Ignition Measurement	The amount of residual substance not volatilized after a sample is ignited.	Residue on Ignition		Tests to measure the amount of residual substance not volatilized from a sample when the sample is ignited in the presence of sulfuric acid. This test is usually used for determining the content of inorganic impurities in an organic substance.
A	C133807	PQ/CMC Test Category Terminology	C134277	Spray Pattern Assessment	Tests to determine the size of the mist formed by spraying. The measurement is made for the longest axis (x axis), and the ratio of longest to shortest axes (x/y ratio).	Spray Pattern		Tests to determine the size of the mist formed by spraying. The measurement is made for the longest axis (x axis), and the ratio of longest to shortest axes (x/y ratio).
A	C133807	PQ/CMC Test Category Terminology	C134278	Sterility Test	Tests done under aseptic conditions to ensure that there are no contaminating micro-organism present in the sample.	Sterility		Tests done under aseptic conditions to ensure that there are no contaminating micro-organism present in the sample.
A	C133807	PQ/CMC Test Category Terminology	C18951	Post Translational Modification Analysis	Laboratory procedures used for the analysis of the processing events of a protein after its translation from messenger RNA in order to gain insight into biological function. These include mass spectrometric peptide sequencing and analysis technologies.	Post-translational Modifications		Test to measure if the protein undergoing post translational modification which include glycosylation etc.
A	C133807	PQ/CMC Test Category Terminology	C193381	Particulate Testing	Analysis of particulate or foreign material returned from user for evaluation.	Foreign and Particulate Matter		Tests for injections or infusions to check for insoluble particles to confirm that they are not present in excess of specified levels in the solutions.
A	C133807	PQ/CMC Test Category Terminology	C200004	Cytotoxicity Assay	A laboratory assessment to determine cytotoxicity (induction of cell death) as the result of in vivo or in vitro exposure to test article.	Cytotoxicity		Test methods designed to evaluate the acute adverse biological effects of extractables from medical device materials.
A	C133807	PQ/CMC Test Category Terminology	C204971	Impurity Test	Analytical procedures to establish material purity by determining the presence of a material or component that is not defined as the material.	Impurity		Analytical procedures to establish material purity by determining the presence of a material or component of a material that is not defined as the material.
A	C133807	PQ/CMC Test Category Terminology	C205000	Active Substance Functional Assay	Assay to quantify functioning of an active substance to a specific disease.	Functional Assays		Functional assay used to quantify functioning of an active substance rather than just its quantity. Common uses are: showing that a drug target fits the desired functionality and quality profile before moving on to the next stage of development; and comparison of biosimilars with innovator products.
A	C133807	PQ/CMC Test Category Terminology	C205012	Droplet Size Test Measurement	Tests that determine the size of the liquid drop.	Droplet Size		Tests that determine the size of the liquid drop.
A	C133807	PQ/CMC Test Category Terminology	C205013	Elemental Analysis	A qualitative and/or quantitative analytical chemistry methodology used to determine which elements are present in a test sample.	Elemental Analysis		The relative proportion of elements present in a sample.
A	C133807	PQ/CMC Test Category Terminology	C205023	Mechanical Integrity Test	Test that measures what amount of force is needed to alter the mechanical integrity of a construct.	Mechanical Integrity		Test that measures what amount of force is needed to alter the mechanical integrity of a construct.
A	C133807	PQ/CMC Test Category Terminology	C205026	Organoleptic Examination	Evaluation via the senses.	Organoleptic		Evaluation via the senses—including taste, sight, smell, and touch.
A	C133807	PQ/CMC Test Category Terminology	C205027	Osmolality/Osmolarity Measurement	Measurements of the solute concentration of a solution; expressed in terms of either the weight of the solvent or the solvent volume.	Osmolality/Osmolarity		Osmolality and osmolarity are measurements of the solute concentration of a solution. Osmolality is expressed in terms of the weight of the solvent and osmolarity is expressed in terms of solvent volume.
A	C133807	PQ/CMC Test Category Terminology	C205029	pH Measurement	The measure of acidity or alkalinity of an aqueous solution.	pH		The measure of acidity or alkalinity of an aqueous solution.
A	C133807	PQ/CMC Test Category Terminology	C205030	Porosity Measurement	The measurement of the empty spaces/voids in a material.	Porosity		Tests that measure the empty spaces/voids in the material.
A	C133807	PQ/CMC Test Category Terminology	C205032	Refractive Index Measurement	A determination of the refractive index of a sample, defined by the ratio of the speed of light in a vacuum divided by the speed of light in a test sample.	Refractive Index		Tests performed to determine the ratio of velocity of light in air to the velocity of light in the substance.
A	C133807	PQ/CMC Test Category Terminology	C205041	Surface Area Measurement	Total surface area of a 2D or 3D material.	Surface Area		Total surface area of a 2D or 3D material.
A	C133807	PQ/CMC Test Category Terminology	C205049	Transdermal Device Property Test	Tests that determine the physical properties of transdermal systems.	Transdermal Properties		Tests that determine the physical properties of transdermal systems. Example: Peel adhesion test, Tack test, Cold Flow test, etc.
A	C133807	PQ/CMC Test Category Terminology	C25483	Dimension	The magnitude of something in a particular direction, especially length or width or height.	Material Properties/Measurements		Dimensions and physical properties of the material of interest including tablets, capsule, soft gel capsule, granulate or pellet, etc.
A	C133807	PQ/CMC Test Category Terminology	C60821	Solubility	The ability of a particular substance to dissolve in a particular solvent (yielding a saturated solution).	Solubility		A chemical property referring to the ability for a given substance, the solute, to dissolve in a solvent. It is measured in terms of the maximum amount of solute dissolved in a solvent at equilibrium.
A	C133807	PQ/CMC Test Category Terminology	C63394	Melting Point Determination	Determining the temperature at which a crystalline solid changes state from solid to liquid.	Melting Point		The temperature at the which a substance changes from solid to a liquid state at atmospheric pressure.
A	C133807	PQ/CMC Test Category Terminology	C64832	Specific Gravity	The density (mass per unit volume) of any material divided by that of water at a standard temperature.	Specific Gravity		The ratio of the density of any substance to the density of some other substance taken as standard, water being the standard for liquids and solids, and hydrogen or air being the standard for gases.
A	C133807	PQ/CMC Test Category Terminology	C74723	Turbidity Measurement	The determination of the opacity of a sample.	Turbidity		Measurement of the clarity and degree of opalescence of liquids by comparison of the solutions in diffused daylight after preparation of the reference suspension.
A	C133848	PQ/CMC Chemical Structure Data File Type Terminology	C85435	Scalable Vector Graphics	A specification for describing vector graphics using extensible markup language.	SVG		A specification for describing vector graphics using extensible markup language.
A	C176677	PQ/CMC Units of Measure Terminology	C205478	Microgram per Actuation	The amount of micrograms of a substance contained in a single actuation of a device.	ug/{actuation}	micrograms per actuation	
A	C176677	PQ/CMC Units of Measure Terminology	C66832	One	The smallest natural number and quantity it denotes: a single entity, unit, or object.	1*		
A	C176677	PQ/CMC Units of Measure Terminology	C69092	Centipoise	A CGS unit of dynamic viscosity equal to 10E-3 pascal second.	cP	centipoise	
A	C176677	PQ/CMC Units of Measure Terminology	C75765	Arbitrary Unit	A single undivided thing (unit) based on or subject to individual judgment or preference, and not by necessity, reason, or principle.	[arb'U]		
A	C176677	PQ/CMC Units of Measure Terminology	C92953	Amb a 1 Unit	An arbitrary unit for the measurement of Amb a 1 (or Antigen E), a 38 kD glycoprotein that is the major allergen in short ragweed pollen allergen extracts.	[Amb'a'1'U]	Amb a 1 units	
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	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	C204862	PQ/CMC Test Subcategory Terminology	C134002	Residual Solvent Test	Tests performed to determine if organic volatile chemicals that are used or produced in manufacture of drug substance or excipients, or in the preparation of drug products are present in the pharmaceuticals.	Residual Solvent		Tests performed to determine if organic volatile chemicals that are used or produced in manufacture of drug substance or excipients, or in the preparation of drug products are present in the pharmaceuticals.
A	C204862	PQ/CMC Test Subcategory Terminology	C134115	Uniformity of Dosage Units Analysis	An evaluation of the content uniformity in terms of amount of drug substance among dosage units.	Uniformity of Dosage Unit		Tests of the variability each of the dosage unit's dispensed dose.
A	C204862	PQ/CMC Test Subcategory Terminology	C134254	Impurities/Degradation Products/Related Substances Test	Analytical procedures that determine the presence of a component of the material that is not the chemical entity defined as the material.	Impurities/Degradation Products/Related Substances		Tests that establish the characteristic and uniqueness of the substance of interest and should be able to discriminate between compounds of closely related structures which are likely to be present. Includes leachables and extractables.
A	C204862	PQ/CMC Test Subcategory Terminology	C134261	Clarity of Solution Measurement	Measurement of the turbidity of the solution.	Clarity of Solution		Measurement of the turbidity of the solution or qualitative or quantitative measurement of degree of opalescence of a solution, including instrumental measurement of the light reflected by the solution.
A	C204862	PQ/CMC Test Subcategory Terminology	C134262	Color of Solution Measurement	The color of a solution compared to that of a standard solution.	Color of Solution		The use of visual perception to indicate of purity and/or a means to identify contamination.
A	C204862	PQ/CMC Test Subcategory Terminology	C138990	Product Description/Appearance Assessment	Tests using visual inspection to assess the physical state and color of the drug substance or product.	Description/Appearance		Tests using visual inspection to assess the physical state and color of the drug substance or product.
A	C204862	PQ/CMC Test Subcategory Terminology	C139027	Odor Detection	Determining any smells associated with a material.	Odor		Testing via the sense of smell.
A	C204862	PQ/CMC Test Subcategory Terminology	C16643	Protein Glycosylation	The covalent chemical or post-translational biochemical addition of carbohydrate or glycosyl groups to peptides or proteins by glycosyl transferases.	Glycosylation		Post translation modification due to addition of sugar.
A	C204862	PQ/CMC Test Subcategory Terminology	C171277	Nucleic Acid Concentration Measurement	The measured concentration of nucleic acid in a sample.	Nucleic Acid Content		Tests designed to reveal the presence of a particular nucleic acid from a test sample.
A	C204862	PQ/CMC Test Subcategory Terminology	C204845	Active Ingredient Assay	Qualitative or quantitative measurements of an active ingredient of a pharmacologic product.	Active Ingredient Content		Tests that verify the content and potency of a pharmaceutical substance that is intended to have an effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to impact a structure or function of the body.
A	C204862	PQ/CMC Test Subcategory Terminology	C204890	Chemical Impurity Test	Analytical procedures that determine the presence of a component of the material that is not the chemical entity defined as the material.	Impurity Chemical		Analytical procedures to establish chemical purity by determining the presence of a component of the material that is not the chemical entity defined as the material.
A	C204862	PQ/CMC Test Subcategory Terminology	C205001	Adventitious Agent Assay	In vitro and in vivo assays for detection of potentially harmful unintended agents.	Adventitious Agents (Safety)		In vitro and in vivo assays for detection of unintended agents such as viral, bacterial, fungal agents which have undesirable adverse impact on patient's health.
A	C204862	PQ/CMC Test Subcategory Terminology	C205002	Amidation Assay	An assessment of the degree to which bioactive peptides have undergone amidation, the process by which a side-chain carboxyl group acquires an alpha-amide.	Amidation		Testing for and acid containing residue conversion to an amide.
A	C204862	PQ/CMC Test Subcategory Terminology	C205003	Bioburden Test	The determination of the type and number of viable microorganisms in a test sample	Bioburden		Test that screens for aerobic mesophilic bacteria and fungi.
A	C204862	PQ/CMC Test Subcategory Terminology	C205004	Blend Uniformity Test	A testing process that evaluates the consistency of a blended sample of active ingredients and excipients (or inactive ingredients) of a drug product.	Blend Uniformity		Test to ensure the adequacy of the mixing of active pharmaceutical ingredients (APIs) with other components of the drug product.
A	C204862	PQ/CMC Test Subcategory Terminology	C205005	Capsule Lock Length Measurement	The straight line measurement from the longest edge-to-edge distance through a capsule body and cap that have been coupled such that the locking rings are sealed as designed.	Lock Length		The length of a straight line measurement from the longest edge-to-edge distance through a Capsule body and cap that have been coupled such that the locking rings are sealed as designed.
A	C204862	PQ/CMC Test Subcategory Terminology	C205006	Cell and Gene Therapy Product Characterization Assay	Assay to determine or quantify the functionality of cellular and genetic therapy products.	Cell and Gene Therapy Product Characterization Assay		Tests to determine Cell and Gene therapy product properties. Examples: Viability, Cell number, Morphology, Cell surface markers, Secreted molecules, Gene expression, Genetic stability, percent recovery, gene expression, cell surface marker expression, proliferation capacity, total cell number, cell morphology, cell distribution in scaffold, total volume of scaffold, cellular pattern, vector genome concentration, vector infectious titer assay, replication competence assay, DNA homogeneity, transduction efficiency, vector genome concentration, vector infectious titer assay, Replication competence assay.
A	C204862	PQ/CMC Test Subcategory Terminology	C205007	Counterion Content Assessment	Tests to detect and quantify counterions in a substance.	Counterion Content		Tests that measure the secondary ion of a drug salt.
A	C204862	PQ/CMC Test Subcategory Terminology	C205008	Deamidation Assessment	An assessment of the degree to which bioactive peptides have undergone deamidation, the process by which a side-chain amide group of asparagine is converted into a carboxylic acid.	Deamidation		Testing for an amide residue conversion to an acid.
A	C204862	PQ/CMC Test Subcategory Terminology	C205009	Dose Orifice Depth Drilled Measurement	The depth measurement of the penetration of the hole drilled in the unit dose as measured from the outer edge to the deepest point of penetration.	Orifice Depth		The measurement of the penetration of the hole drilled in the unit dose as measured from the outer edge to the deepest point of penetration.
A	C204862	PQ/CMC Test Subcategory Terminology	C205010	Dose Orifice Diameter Drilled Measurement	The straight line length across the center of the hole drilled in the unit dose.	Orifice Diameter		The length of a straight line measurement across the center of the hole drilled in the unit dose.
A	C204862	PQ/CMC Test Subcategory Terminology	C205011	Dose Orifice Location Measurement	The position of hole drilled in the unit dose.	Orifice Location		The position of hole drilled in the unit dose.
A	C204862	PQ/CMC Test Subcategory Terminology	C205014	Elemental Impurity Analysis	An analytical chemistry methodology used to identify and quantify elemental contaminants in a test sample.	Elemental Impurity		Analytical procedures that determine the amount of single elements in drug products or drug product components.
A	C204862	PQ/CMC Test Subcategory Terminology	C205015	Excipient Measurement	Testing of the amount of material other than the active Ingredient or adjuvant in a product.	Excipient		Testing of the amount of material other than the active or adjuvant.
A	C204862	PQ/CMC Test Subcategory Terminology	C205016	Group Fill Substance Weight Measurement	The sum of fill substance weights of a collection of units.	Group Fill Weight		The sum of fill weights of material of interest across a specified collection of units
A	C204862	PQ/CMC Test Subcategory Terminology	C205017	Group Substance Weight Measurement	The sum of weights of a substance in a collection.	Group Weight		The sum of weights of material of interest across a specified collection of units
A	C204862	PQ/CMC Test Subcategory Terminology	C205018	Host Cell DNA Measurement	Measurement of DNA that comes from the host cells that were used to generate the viral particles.	Host Cell DNA		Measurement of DNA that comes from cell substrate used to make the viral particles.
A	C204862	PQ/CMC Test Subcategory Terminology	C205019	In Process Control Content Uniformity Tests	In-Process Control tests of the variability of individual dosage units during manufacture as informed by ASTM E2810.	IPC Content Uniformity		In-Process Control (IPC) tests of the variability of individual dosage units during manufacture as informed by ASTM E2810.
A	C204862	PQ/CMC Test Subcategory Terminology	C205020	In Vitro or In Vivo Test for Viral Contaminants	Test used to measure viral contamination both by in vitro and in vivo assay.	In Vitro or In Vivo Test for Viral Contaminants		Test used to measure viral contamination both by in vitro and in vivo assays
A	C204862	PQ/CMC Test Subcategory Terminology	C205021	Individual Substance Fill Weight Measurement	The substance fill weight of an individual unit.	Individual Fill Weight		The weight of material of interest within a single unit. Example: 1 gram (in each vial), 200 mg (in each capsule) note: could be a capsule, vial, or bottle.
A	C204862	PQ/CMC Test Subcategory Terminology	C205022	Individual Substance Weight Measurement 	The weight of a single unit of the substance.	Individual Weight		The weight of a single unit of the material of interest. Example: 800 mg tablet
A	C204862	PQ/CMC Test Subcategory Terminology	C205024	Metal Level Detection Test	Tests for metallic particles to confirm that they are not present in excess of specified levels.	Metal Detection		Tests for metallic particles to confirm that they are not present in excess of specified levels.
A	C204862	PQ/CMC Test Subcategory Terminology	C205025	Number of Dose Orifices Drilled Count	The total count of holes drilled in the unit dose.	Number of Orifices		The total count of holes drilled in the unit dose. [Source: SME Defined]
A	C204862	PQ/CMC Test Subcategory Terminology	C205028	Percent Conjugated Protein Measurement	A determination of the ratio of chemically conjugated proteins to the amount of total proteins, expressed as a percentage.	Percent Conjugate		Test to determine the percentage of total protein that functions in interaction with other (non-polypeptide) chemical groups attached by covalent bonding.
A	C204862	PQ/CMC Test Subcategory Terminology	C205031	Protein Sialylation	Post translational modification of proteins by sialylation.	Sialylation		Post translational modification of proteins by sialylation.
A	C204862	PQ/CMC Test Subcategory Terminology	C205033	Ribbon Density	The compactness of a continuous sheet of compressed material in preparation for subsequent processing.	Ribbon Density		The compactness of a continuous sheet of compressed material in preparation for subsequent processing.
A	C204862	PQ/CMC Test Subcategory Terminology	C205034	Ribbon Thickness	The dimension between two surfaces of a continuous sheet of compressed material in preparation for subsequent processing.	Ribbon Thickness		The dimension between two surfaces of a continuous sheet of compressed material in preparation for subsequent processing.
A	C204862	PQ/CMC Test Subcategory Terminology	C205035	Seam Thickness Measurement	The measurement of overlap common to two edges of the same material joined together.	Seam Thickness		The measurement of overlap common to two edges of the same material joined together. Example: 1 mm
A	C204862	PQ/CMC Test Subcategory Terminology	C205036	Shell Weight Measurement	The weight of outer casing of a pharmacologic product.	Shell Weight		The weight of outer casing ("shell") into which material of interest is filled. Example: 20 mg
A	C204862	PQ/CMC Test Subcategory Terminology	C205037	Single or Double Drilled Side Assessment	An observation if one or both sides of a unit dose have been drilled.	Drilled Side (Single or Double)		An observation if one or both sides of the unit dose has been drilled.
A	C204862	PQ/CMC Test Subcategory Terminology	C205038	Solvate Content Identification	An assay of water or solvent found in a crystal to identify any hydrates or solvates present.	Solvate Content		Identification of hydrates or solvates by the assay of water of crystallization or solvent found in the crystal.
A	C204862	PQ/CMC Test Subcategory Terminology	C205039	Specified Identified Impurity Test	Testing for an impurity that is individually listed and limited with a specific acceptance criterion in the new drug substance or drug product specification and for which a structured characterization has been achieved.	Specified Identified Impurity		Testing for an impurity that is individually listed and limited with a specific acceptance criterion in the new drug substance or drug product specification and for which a structured characterization has been achieved. Note: this includes degradation products for tests conducted on drug products.
A	C204862	PQ/CMC Test Subcategory Terminology	C205040	Specified Unidentified Impurity Test	Testing for an impurity that is individually listed and limited with a specific acceptance criterion in the new drug substance or drug product specification and that is defined solely by qualitative analytical properties and lacks a structured characterization.	Specified Unidentified Impurity		Testing for an impurity that is individually listed and limited with a specific acceptance criterion in the new drug substance or drug product specification and that is defined solely by qualitative analytical properties (e.g., chromatographic retention time) due to the lack of achieving a structured characterization. Note: this includes degradation products for tests conducted on drug products.
A	C204862	PQ/CMC Test Subcategory Terminology	C205042	Tablet Thickness Measurement	The length of a straight line measurement from the shortest edge-to-edge distance through a tablet.	Tablet Thickness		The length of a straight line measurement from the shortest edge-to-edge distance through a Tablet.
A	C204862	PQ/CMC Test Subcategory Terminology	C205043	Tablet/Capsule Diameter Measurement	The length of a straight line measurement across the circular center of a tablet/capsule.	Tablet/Capsule Diameter		The length of a straight line measurement across the circular center of a Tablet/Capsule.
A	C204862	PQ/CMC Test Subcategory Terminology	C205044	Tablet/Capsule Length Measurement	The length of a straight line measurement from the longest edge-to-edge distance through the tablet/capsule.	Tablet/Capsule Length		The length of a straight line measurement from the longest edge-to-edge distance through the Tablet/Capsule.
A	C204862	PQ/CMC Test Subcategory Terminology	C205045	Target Group Product Weight Gain Percentage	A predetermined percentage weight increase for a set of units resulting from an action such as coating.	Target Group Weight Gain %		A predetermined percentage weight increases for a set of units resulting from of an action such as coating. Example: 3% (weight gain after coating) note: this can be associated with a bulk material or a single unit.
A	C204862	PQ/CMC Test Subcategory Terminology	C205047	Total Product Impurity above Threshold Assay	The sum of all impurities in a product at a level greater than the reporting threshold.	Total Impurities		The sum of all impurities at a level greater than (>) the reporting threshold. Note: this includes degradation products for tests conducted on drug products.
A	C204862	PQ/CMC Test Subcategory Terminology	C205048	Total Product Unknown Impurity Assay	The sum of unknown (unidentified) impurities in a new drug substance or product specification.	Total Unknown Impurities		The sum of unknown (unidentified) impurities in a new drug substance or drug product specification. Note: Total impurities includes all impurities while Total Unknown impurities only includes all the unknown impurities.
A	C204862	PQ/CMC Test Subcategory Terminology	C205050	Content Uniformity in Container	The consistency of an active ingredient throughout the container of the product.	Uniformity in Containers		The consistency of the active ingredient throughout multi-use containers such as tubes, and jars of semi-solids.
A	C204862	PQ/CMC Test Subcategory Terminology	C205051	Unspecified Product Impurity below ICH Identification Threshold	Identified unspecified impurities which are below the ICH (International Council for Harmonisation) identification threshold in a pharmacologic product.	Identified Impurity under IT, Monitored as Unspecified		Identification (chemical name and/or UNII code) of all the identified (known) impurities that are being controlled as "unspecified impurities" rather than "Specified Identified Impurity" due to the level being consistently below the ICH identification threshold (IT) value. Note: this includes degradation products for tests conducted on drug products.
A	C204862	PQ/CMC Test Subcategory Terminology	C205052	Unspecified Product Impurity Test	Testing for a product impurity that is limited by a general acceptance criterion, but not individually listed with its own specific acceptance criterion.	Unspecified Impurity		Testing for an impurity that is limited by a general acceptance criterion, but not individually listed with its own specific acceptance criterion, in the new drug substance or drug product specification. Note: this includes degradation products for tests conducted on drug products.
A	C204862	PQ/CMC Test Subcategory Terminology	C205053	Weight/Concentration Variation Test	The difference in weights or concentration of an ingredient in a finished pharmaceutical product.	Weight Variation		The difference in weights of the material of interest. Examples: 2%, 5 mg, 2.5 % note: may be a percent, a value, or a percent relative standard deviation. [Source: SME Defined]
A	C204862	PQ/CMC Test Subcategory Terminology	C205054	Thrombin Peptide Map	A representation of the composition of a protein resulting from cleavage of a test sample by thrombin.	Thrombin Peptide Map		Map of peptides derived from digestion of protein with thrombin.
A	C204862	PQ/CMC Test Subcategory Terminology	C205206	Average Fill Substance Weight Measurement	The sum of substance fill weights of material of interest across multiple units divided by the number of units included in the sum.	Average Fill Weight		The sum of fill weights of material of interest across multiple units divided by the number of units included in the sum.
A	C204862	PQ/CMC Test Subcategory Terminology	C205209	Average Substance Weight Measurement	The sum of weights of a substance across multiple units divided by the number of units included in the sum.	Average Weight		The sum of weights of material of interest across multiple units divided by the number of units included in the sum.
A	C204862	PQ/CMC Test Subcategory Terminology	C62352	Purity Assessment	A quantitative assessment of the homogeneity or uniformity of a mixture. Alternatively, purity refers to the degree of being free of contaminants or heterogeneous components.	Purity		Testing methods to identify actives and indirectly measure impurities that may be present in a medicine. Examples of analytical procedures for this test subcategory include SDS-PAGE and HPLC.
A	C204862	PQ/CMC Test Subcategory Terminology	C64858	Total Protein Measurement	A quantitative measurement of the amount of total protein present in a sample.	Total Protein		Test to determine total protein concentration in the product.
A	C204862	PQ/CMC Test Subcategory Terminology	C81183	Amino Acid Measurement	The measurement of the amount of amino acids in a biologic specimen.	Amino Acid Content		Methodology used to determine the amino acid composition or content of proteins, peptides, and other pharmaceutical preparations.
A	C205477	PQ/CMC Substance Classification Terminology	C103206	Structurally Diverse Substance	A type of polydisperse substance isolated from a single source that is a complex mixture which cannot be described as a limited set of single substance.	Structurally Diverse Substance		
A	C205477	PQ/CMC Substance Classification Terminology	C17021	Protein	A group of complex organic macromolecules composed of one or more chains (linear polymers) of alpha-L-amino acids linked by peptide bonds and ranging in size from a few thousand to over 1 million Daltons. Proteins are fundamental genetically encoded components of living cells with specific structures and functions dictated by amino acid sequence.	Protein		A group of complex organic macromolecules composed of one or more chains (linear polymers) of alpha-L-amino acids linked by peptide bonds and ranging in size from a few thousand to over 1 million Daltons. Proteins are fundamental genetically encoded components of living cells with specific structures and functions dictated by amino acid sequence.
A	C205477	PQ/CMC Substance Classification Terminology	C45305	Mixture	A substance consisting of two or more substances mixed together (not in fixed proportions and not with chemical bonding).	Mixture		A substance consisting of two or more substances mixed together (not in fixed proportions and not with chemical bonding).
A	C205477	PQ/CMC Substance Classification Terminology	C48803	Polymer	A substance made up of variable numbers of repeating structural units linked through covalent bonds.	Polymer		A substance made up of variable numbers of repeating structural units linked through covalent bonds.
A	C205477	PQ/CMC Substance Classification Terminology	C48807	Chemical	A substance with a defined atomic or molecular structure that results from, or takes part in, reactions involving changes in its structure, composition, or properties.	Chemical		A substance with a defined atomic or molecular structure that results from, or takes part in, reactions involving changes in its structure, composition, or properties.
A	C205477	PQ/CMC Substance Classification Terminology	C706	Nucleic Acids	Type of substance that may be described as a linear sequence of nucleosides typically linked through phosphate esters.	Nucleic Acids		Type of substance that may be described as a linear sequence of nucleosides typically linked through phosphate esters.
C	C133807	PQ/CMC Test Category Terminology	C138993	Material Identification Test	Tests that establishes the characteristic and uniqueness of the substance of interest and should be able to discriminate between compounds of closely related structures which are likely to be present.	Identification		Tests that establish the characteristic and uniqueness of the substance of interest and should be able to discriminate between compounds of closely related structures which are likely to be present.
C	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.
C	C176676	PQ/CMC Excipient Function Terminology	C176637	Absorption Modifying Excipient	A substance within a formulation that is used to enhance the bioavailability of the agent by modifying its absorption properties.	Absorption modifier		An excipient included in formulations to improve the absorption of a pharmacologically active drug (e.g. permeation enhancer; transmucosal absorption enhancer; intestinal permeation enhancer; delivery agent; penetration enhancer; transdermal delivery agent).
C	C176676	PQ/CMC Excipient Function Terminology	C275	Antioxidant	A group of organic or inorganic substances capable of preventing the genotoxic and carcinogenic effects of free-radical compounds. Antioxidants bind to and neutralize ('scavenge') free radicals, thereby transforming them into non-toxic compounds and blocking their genotoxic and carcinogenic effects. This class of agents includes the vitamins C and E, the carotenoids, and selenium. Organic antioxidants are found in high concentrations in fruits, seeds and vegetables.	Antioxidant		Agent used to stabilize a system against oxidative degradation. (Adapted from Medicinescomplete)
C	C203777	PQ/CMC Ingredient Location Terminology	C203881	Active Core Granule	A granule core containing an active pharmaceutical ingredient (API) as opposed to the API being in the coating and not in the core.	Active core/granulate		The location of the ingredient of interest is within a starter core (granulate, bead or tablet) with no applied coating.
D	C133807	PQ/CMC Test Category Terminology	C138990	Product Description/Appearance	Tests using visual inspection to assess the physical state and color of the drug substance or product.	Description		An assessment of the physical state (e.g., color, shape, size) of the drug substance or product. [Source: Adapted from ICH Q6A]
D	C133807	PQ/CMC Test Category Terminology	C158423	Chemical Impurity	Any unwanted organic, inorganic, and residual solvents in drug substances and final products.	Impurities		Analytical procedures that determine the presence of a component of the material that is not the chemical entity defined as the material.
D	C133807	PQ/CMC Test Category Terminology	C158425	Biological Property	Characteristics of biological systems.	Biological Properties		Any effect a given material has on a living organism (e.g., microbial limits, endotoxin).
D	C133807	PQ/CMC Test Category Terminology	C176810	Microbiological Property	The characteristics of, or the effects of a material on a microorganism or microbiome.	Microbiological Properties		The characteristics of, or the effects of a material on a microorganism or microbiome.
D	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.