Generated Narrative: ValueSet pqcmc-test-category-terminology

• Include these codes as defined in http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy

  Code	Display	Definition
  C60819	Assay	A qualitative or quantitative analysis performed to determine the amount of a particular constituent in a sample or the biological or pharmacological properties of a drug.
  C204845	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.
  C205001	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.
  C81183	Amino Acid Content	Methodology used to determine the amino acid composition or content of proteins, peptides, and other pharmaceutical preparations.
  C205003	Bioburden	Test that screens for aerobic mesophilic bacteria and fungi.
  C205007	Counterion Content	Tests that measure the secondary ion of a drug salt.
  C205015	Excipient	Testing of the amount of material other than the active or adjuvant.
  C205018	Host Cell DNA	Measurement of DNA that comes from cell substrate used to make the viral particles.
  C205020	In Vitro or In Vivo Test for Viral Contaminants	Test used to measure viral contamination both by in vitro and in vivo assays
  C205028	Percent Conjugate	Test to determine the percentage of total protein that functions in interaction with other (non-polypeptide) chemical groups attached by covalent bonding.
  C62352	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.
  C171277	Nucleic Acid Content	Tests designed to reveal the presence of a particular nucleic acid from a test sample.
  C205038	Solvate Content	Identification of hydrates or solvates by the assay of water of crystallization or solvent found in the crystal.
  C64858	Total Protein	Test to determine total protein concentration in the product.
  C205006	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.
  C134249	Container Closure Integrity	Tests for the adequacy of pharmaceutical packaging and container closures.
  C134250	Uniformity	Tests to ensure the consistency of the API in the formulation. Test may be done as an IPC, release, or stability test.
  C205004	Blend Uniformity	Test to ensure the adequacy of the mixing of active pharmaceutical ingredients (APIs) with other components of the drug product.
  C205019	IPC Content Uniformity	In-Process Control (IPC) tests of the variability of individual dosage units during manufacture as informed by ASTM E2810.
  C134115	Uniformity of Dosage Unit	Tests of the variability each of the dosage unit's dispensed dose.
  C205050	Uniformity in Containers	Content Uniformity based for multi-use containers, tubes, and jars. The consistency of the active ingredient throughout multi-use containers such as tubes, and jars of semi-solids.
  C133961	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.
  C205026	Organoleptic	Evaluation via the senses—including taste, sight, smell, and touch.
  C138990	Description/Appearance	Tests using visual inspection to assess the physical state and color of the drug substance or product.
  C139027	Odor	Testing via the sense of smell.
  C134262	Color of Solution	The use of visual perception to indicate of purity and/or a means to identify contamination.
  C134261	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.
  C138993	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.
  C134252	Disintegration	Test to determine whether tablets capsules disintegrate within the prescribed time when placed in a liquid medium at the experimental conditions.
  C134253	Dissolution	Test to determine compliance with the requirements of the material of interest dissolving into solution.
  C205012	Droplet Size	Tests that determine the size of the liquid drop.
  C193381	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.
  C205024	Metal Detection	Tests for metallic particles to confirm that they are not present in excess of specified levels.
  C134255	Loss on Drying	Analytical procedures to determine the amount of volatile matter of any kind that is driven off under the conditions specified.
  C134256	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.
  C205027	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.
  C134257	Particle Size Distribution	Analytical procedures that utilize mechanical sieving for deducing the particle-size distribution of a powdered solid.
  C134260	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.
  C134263	Conductivity	Electrical conductivity is a measure of the ion-facilitated electron flow through it.
  C133974	Crystallinity	The detection and/or quantification of the amount of amorphous material within a highly crystalline substance.
  C133975	Friability	The percent loss of a tablet due to mechanical action that results in fracture or breaking during the test
  C134264	Hardness	A test used to identify the ability of a material to resist mechanical deformation such as scratching or penetration by other substances.
  C63394	Melting Point	The temperature at the which a substance changes from solid to a liquid state at atmospheric pressure.
  C103201	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.
  C205029	pH	The measure of acidity or alkalinity of an aqueous solution.
  C60821	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.
  C64832	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.
  C25483	Material Properties/Measurements	Dimensions and physical properties of the material of interest including tablets, capsule, soft gel capsule, granulate or pellet, etc.
  C205022	Individual Weight	The weight of a single unit of the material of interest. Example: 800 mg tablet
  C205017	Group Weight	The sum of weights of material of interest across a specified collection of units
  C205209	Average Weight	The sum of weights of material of interest across multiple units divided by the number of units included in the sum.
  C205053	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]
  C205021	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.
  C205016	Group Fill Weight	The sum of fill weights of material of interest across a specified collection of units
  C205206	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.
  C205045	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.
  C205036	Shell Weight	The weight of outer casing ("shell") into which material of interest is filled. Example: 20 mg
  C205011	Orifice Location	The position of hole drilled in the unit dose.
  C205010	Orifice Diameter	The length of a straight line measurement across the center of the hole drilled in the unit dose.
  C205009	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.
  C205037	Drilled Side (Single or Double)	An observation if one or both sides of the unit dose has been drilled.
  C205025	Number of Orifices	The total count of holes drilled in the unit dose. [Source: SME Defined]
  C205034	Ribbon Thickness	The dimension between two surfaces of a continuous sheet of compressed material in preparation for subsequent processing.
  C205033	Ribbon Density	The compactness of a continuous sheet of compressed material in preparation for subsequent processing.
  C205035	Seam Thickness	The measurement of overlap common to two edges of the same material joined together. Example: 1 mm
  C205005	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.
  C205044	Tablet/Capsule Length	The length of a straight line measurement from the longest edge-to-edge distance through the Tablet/Capsule.
  C205043	Tablet/Capsule Diameter	The length of a straight line measurement across the circular center of a Tablet/Capsule.
  C205042	Tablet Thickness	The length of a straight line measurement from the shortest edge-to-edge distance through a Tablet.
  C134266	Tap Density	An increased bulk density attained after mechanically tapping the container containing the powder sample. (aka - tapped density)
  C205049	Transdermal Properties	Tests that determine the physical properties of transdermal systems. Example: Peel adhesion test, Tack test, Cold Flow test, etc.
  C133979	Viscosity/Rheological Properties	Tests to measure a property of liquids that is closely related to the resistance to flow.
  C134267	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.
  C134269	Polymorphism	Tests to determine the different crystalline forms of a given drug substance
  C205030	Porosity	Tests that measure the empty spaces/voids in the material.
  C134270	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.
  C133983	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.
  C134272	Reconstitution Time	Measurement of how long it takes to restore something dried to its original state of liquid.
  C133985	Redispersibility	Testing of oral suspensions that settle on storage (produce sediment) to measure the time required to achieve resuspension.
  C205032	Refractive Index	Tests performed to determine the ratio of velocity of light in air to the velocity of light in the substance.
  C134276	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.
  C134277	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).
  C134278	Sterility	Tests done under aseptic conditions to ensure that there are no contaminating micro-organism present in the sample.
  C134113	Syringe Functionality	Tests performed on syringes to ensure that It operates as specified.
  C134114	Total Organic Carbon	An indirect measure of organic molecules present in pharmaceutical waters measured as carbon.
  C200004	Cytotoxicity	Test methods designed to evaluate the acute adverse biological effects of extractables from medical device materials.
  C205023	Mechanical Integrity	Test that measures what amount of force is needed to alter the mechanical integrity of a construct.
  C205041	Surface Area	Total surface area of a 2D or 3D material.
  C18951	Post-translational Modifications	Test to measure if the protein undergoing post translational modification which include glycosylation etc.
  C16643	Glycosylation	Post translation modification due to addition of sugar.
  C205054	Thrombin Peptide Map	Map of peptides derived from digestion of protein with thrombin.
  C205031	Sialylation	Post translational modification of proteins by sialylation.
  C205002	Amidation	Testing for and acid containing residue conversion to an amide.
  C205008	Deamidation	Testing for an amide residue conversion to an acid.
  C205000	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.
  C205013	Elemental Analysis	The relative proportion of elements present in a sample.
  C74723	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.
  C204971	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.
  C205039	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.
  C205040	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.
  C205052	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.
  C205047	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.
  C205048	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.
  C205051	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.
  C205014	Elemental Impurity	Analytical procedures that determine the amount of single elements in drug products or drug product components.
  C204890	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.
  C134254	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.
  C134002	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.

Generated Narrative: ValueSet

Expansion based on codesystem PQ-CMC-FDA Temporary Codes v1.1.6 (CodeSystem)

This value set contains 108 concepts