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: Specification Type Terminology

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-terminology Version: 2.0.0-ballot
Active as of 2024-12-04 Computable Name: PqcmcSpecificationTypeTerminology
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.48.24

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

References

Logical Definition (CLD)

Generated Narrative: ValueSet pqcmc-specification-type-terminology

 

Expansion

Generated Narrative: ValueSet

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

This value set contains 3 concepts

CodeSystemDisplay
  C134021http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlDrug Product Specification
  C134022http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlDrug Substance Specification
  C133931http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlRaw Materials/Excipients/Intermediates/Reagents Specification

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