Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon 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 1.1.6 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 Section Type Terminology

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-specification-types-vs Version: 1.1.6
Draft as of 2024-09-22 Computable Name: PqcmcQualitySpecificationSectionTypes
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.48.37

Local value set of all codes in Specification Type codes

References

Logical Definition (CLD)

Generated Narrative: ValueSet cmc-specification-types-vs

 

Expansion

Generated Narrative: ValueSet

Expansion based on codesystem Code System PQCMC Comp Section Types v1.1.6 (CodeSystem)

This value set contains 3 concepts

CodeSystemDisplay
  32P51http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Specification
  32S41http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Specification
  32P40http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Control of Excipients

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