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: Release Profile Terminology

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile Version: 2.0.0-ballot
Active as of 2024-12-04 Computable Name: PqcmcReleaseProfile
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.48.21

A category of terminology used to qualify the information pertaining to release profile in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

References

Logical Definition (CLD)

Generated Narrative: ValueSet pqcmc-release-profile

 

Expansion

Generated Narrative: ValueSet

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

This value set contains 4 concepts

CodeSystemDisplay
  C42730http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlDelayed Release Dosage Form
  C42713http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlExtended Release Dosage Form
  C42669http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlImmediate Release Dosage Form
  C48660http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlNot Applicable

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