Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan United States of America flag

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

ValueSet: Impurity Classification Terminology

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-impurity-classification-terminology Version: 2.0.0-ballot
Active as of 2024-12-04 Computable Name: PqcmcImpurityClassificationTerminology
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.48.36

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

References

Logical Definition (CLD)

Generated Narrative: ValueSet pqcmc-impurity-classification-terminology

  • Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    CodeDisplay
    C176816Degradation Product
    C185190Elemental Impurities
    C176815Residual Solvent
    C134001Inorganic
    C176812Process Related/Process
    C185192Leachables
    C176813Product Related
    C92081Microbiological

 

Expansion

Generated Narrative: ValueSet

Expansion based on supplement PQ-CMC-FDA NCIt Hieararchy Supplement v2.0.0-ballot (CodeSystem)

This value set contains 8 concepts

CodeSystemDisplay
  C176816http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlDegradant
  C185190http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlElemental Impurity
  C176815http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlResidual Solvent
  C134001http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlInorganic Impurity
  C176812http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlProcess Related Impurity
  C185192http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlLeachable Material
  C176813http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlProduct Related Impurity
  C92081http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlMicrobial Contamination

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