Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
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-ballot 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
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology | Version: 2.0.0-ballot | |||
| Active as of 2024-12-04 | 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
Generated Narrative: ValueSet pqcmc-test-category-terminology
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 |
Generated Narrative: ValueSet
Expansion based on supplement PQ-CMC-FDA NCIt Hieararchy Supplement v2.0.0-ballot (CodeSystem)
This value set contains 108 concepts
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 |
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change