Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

## ValueSet: Test Category Terminology

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology | Version: 2.0.0
Standards status: Trial-use | Maturity Level: 2 | Computable Name: PqcmcTestCategoryTerminology
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.48.28

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

References

- Quality Specification

### Logical Definition (CLD)

This ValueSet requires the Code system Supplement PQ-CMC-FDA NCIt Hierarchy Supplement.

- Include these codes as defined in `http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl`

  Code | Display
  C60819 | Assay
  C204845 | Active Ingredient Content
  C205001 | Adventitious Agents (Safety)
  C81183 | Amino Acid Content
  C205003 | Bioburden
  C205007 | Counterion Content
  C205015 | Excipient
  C205018 | Host Cell DNA
  C205020 | In Vitro or In Vivo Test for Viral Contaminants
  C205028 | Percent Conjugate
  C62352 | Purity
  C171277 | Nucleic Acid Content
  C205038 | Solvate Content
  C64858 | Total Protein
  C205006 | Cell and Gene Therapy Product Characterization Assay
  C134249 | Container Closure Integrity
  C134250 | Uniformity
  C205004 | Blend Uniformity
  C205019 | IPC Content Uniformity
  C134115 | Uniformity of Dosage Unit
  C205050 | Uniformity in Containers
  C133961 | Deliverable Volume/Fill Volume
  C205026 | Organoleptic
  C138990 | Description/Appearance
  C139027 | Odor
  C134262 | Color of Solution
  C134261 | Clarity of Solution
  C138993 | Identification
  C134252 | Disintegration
  C134253 | Dissolution
  C205012 | Droplet Size
  C193381 | Foreign and Particulate Matter
  C205024 | Metal Detection
  C134255 | Loss on Drying
  C134256 | Microbial Limits
  C205027 | Osmolality/Osmolarity
  C134257 | Particle Size Distribution
  C134260 | Bulk Density
  C134263 | Conductivity
  C133974 | Crystallinity
  C133975 | Friability
  C134264 | Hardness
  C63394 | Melting Point
  C103201 | Optical Rotation
  C205029 | pH
  C60821 | Solubility
  C64832 | Specific Gravity
  C25483 | Material Properties/Measurements
  C205022 | Individual Weight
  C205017 | Group Weight
  C205209 | Average Weight
  C205053 | Weight Variation
  C205021 | Individual Fill Weight
  C205016 | Group Fill Weight
  C205206 | Average Fill Weight
  C205045 | Target Group Weight Gain %
  C205036 | Shell Weight
  C205011 | Orifice Location
  C205010 | Orifice Diameter
  C205009 | Orifice Depth
  C205037 | Drilled Side (Single or Double)
  C205025 | Number of Orifices
  C205034 | Ribbon Thickness
  C205033 | Ribbon Density
  C205035 | Seam Thickness
  C205005 | Lock Length
  C205044 | Tablet/Capsule Length
  C205043 | Tablet/Capsule Diameter
  C205042 | Tablet Thickness
  C134266 | Tap Density
  C205049 | Transdermal Properties
  C133979 | Viscosity/Rheological Properties
  C134267 | Plume Geometry
  C134269 | Polymorphism
  C205030 | Porosity
  C134270 | Potency
  C133983 | Pyrogenicity/Endotoxin
  C134272 | Reconstitution Time
  C133985 | Redispersibility
  C205032 | Refractive Index
  C134276 | Residue on Ignition
  C134277 | Spray Pattern
  C134278 | Sterility
  C134113 | Syringe Functionality
  C134114 | Total Organic Carbon
  C200004 | Cytotoxicity
  C205023 | Mechanical Integrity
  C205041 | Surface Area
  C18951 | Post-translational Modifications
  C16643 | Glycosylation
  C205054 | Thrombin Peptide Map
  C205031 | Sialylation
  C205002 | Amidation
  C205008 | Deamidation
  C205000 | Functional Assays
  C205013 | Elemental Analysis
  C74723 | Turbidity
  C204971 | Impurity
  C205039 | Specified Identified Impurity
  C205040 | Specified Unidentified Impurity
  C205052 | Unspecified Impurity
  C205047 | Total Impurities
  C205048 | Total Unknown Impurities
  C205051 | Identified Impurity under IT, Monitored as Unspecified
  C205014 | Elemental Impurity
  C204890 | Impurity Chemical
  C134254 | Impurities/Degradation Products/Related Substances
  C134002 | Residual Solvent

### Expansion

Expansion from tx.fhir.org based on supplement PQ-CMC-FDA NCIt Hierarchy Supplement v2.0.0 (CodeSystem)

This value set contains 108 concepts

Code | System | Display (en-US)
C60819 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Assay
C204845 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Active Ingredient Assay
C205001 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Adventitious Agent Assay
C81183 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Amino Acid Measurement
C205003 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Bioburden Test
C205007 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Counterion Content Assessment
C205015 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Excipient Measurement
C205018 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Host Cell DNA Measurement
C205020 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | In Vitro or In Vivo Test for Viral Contaminants
C205028 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Percent Conjugated Protein Measurement
C62352 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Purity Assessment
C171277 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Nucleic Acid Concentration Measurement
C205038 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Solvate Content Identification
C64858 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Total Protein Measurement
C205006 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Cell and Gene Therapy Product Characterization Assay
C134249 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Container Closure Integrity Testing
C134250 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Content Uniformity Test
C205004 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Blend Uniformity Test
C205019 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | In Process Control Content Uniformity Tests
C134115 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Uniformity of Dosage Units Analysis
C205050 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Content Uniformity in Container
C133961 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Deliverable Volume/Fill Volume Test
C205026 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Organoleptic Examination
C138990 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Product Description/Appearance Assessment
C139027 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Odor Detection
C134262 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Color of Solution Measurement
C134261 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Clarity of Solution Measurement
C138993 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Material Identification Test
C134252 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Pharmaceutical Disintegration Test
C134253 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Pharmaceutical Dissolution Test
C205012 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Droplet Size Test Measurement
C193381 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Particulate Testing
C205024 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Metal Level Detection Test
C134255 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Loss on Drying Measurement
C134256 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Microbial Limit Determination
C205027 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Osmolality/Osmolarity Measurement
C134257 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Particle Size Distribution Analysis
C134260 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Powder Bulk Density Measurement
C134263 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Conductivity Measurement
C133974 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Crystallinity Analysis
C133975 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Tablet Friability Determination
C134264 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Hardness Measurement
C63394 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Melting Point Determination
C103201 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | OPTICAL ACTIVITY
C205029 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | pH Measurement
C60821 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Solubility
C64832 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Specific Gravity
C25483 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Dimension
C205022 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Individual Substance Weight Measurement
C205017 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Group Substance Weight Measurement
C205209 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Average Substance Weight Measurement
C205053 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Weight/Concentration Variation Test
C205021 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Individual Substance Fill Weight Measurement
C205016 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Group Fill Substance Weight Measurement
C205206 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Average Fill Substance Weight Measurement
C205045 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Target Group Product Weight Gain Percentage
C205036 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Shell Weight Measurement
C205011 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Dose Orifice Location Measurement
C205010 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Dose Orifice Diameter Drilled Measurement
C205009 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Dose Orifice Depth Drilled Measurement
C205037 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Single or Double Drilled Side Assessment
C205025 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Number of Dose Orifices Drilled Count
C205034 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Ribbon Thickness
C205033 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Ribbon Density
C205035 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Seam Thickness Measurement
C205005 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Capsule Lock Length Measurement
C205044 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Tablet/Capsule Length Measurement
C205043 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Tablet/Capsule Diameter Measurement
C205042 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Tablet Thickness Measurement
C134266 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Tap Density Determination
C205049 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Transdermal Device Property Test
C133979 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Viscosity/Rheological Property Analysis
C134267 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Plume Geometry Test
C134269 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Polymorphic Form Determination
C205030 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Porosity Measurement
C134270 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Potency Assay
C133983 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Pyrogenicity/Endotoxin Assessment
C134272 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Reconstitution Time Measurement
C133985 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Redispersibility Measurement
C205032 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Refractive Index Measurement
C134276 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Residue on Ignition Measurement
C134277 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Spray Pattern Assessment
C134278 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Sterility Test
C134113 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Syringe Functionality Testing
C134114 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Total Organic Carbon Measurement
C200004 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Cytotoxicity Assay
C205023 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Mechanical Integrity Test
C205041 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Surface Area Measurement
C18951 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Post Translational Modification Analysis
C16643 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Protein Glycosylation
C205054 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Thrombin Peptide Map
C205031 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Protein Sialylation
C205002 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Amidation Assay
C205008 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Deamidation Assessment
C205000 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Active Substance Functional Assay
C205013 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Elemental Analysis
C74723 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Turbidity Measurement
C204971 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Impurity Test
C205039 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Specified Identified Impurity Test
C205040 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Specified Unidentified Impurity Test
C205052 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Unspecified Product Impurity Test
C205047 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Total Product Impurity above Threshold Assay
C205048 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Total Product Unknown Impurity Assay
C205051 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Unspecified Product Impurity below ICH Identification Threshold
C205014 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Elemental Impurity Analysis
C204890 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Chemical Impurity Test
C134254 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Impurities/Degradation Products/Related Substances Test
C134002 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Residual Solvent Test

Explanation of the columns that may appear on this page:

Level | A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies
System | The source of the definition of the code (when the value set draws in codes defined elsewhere)
Code | The code (used as the code in the resource instance)
Display | The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
Definition | An explanation of the meaning of the concept
Comments | Additional notes about how to use the code