Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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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 1.0.0-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: Test Method Origin Terminology

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology Version: 1.0.0-ballot
Active as of 2024-04-04 Computable Name: PqcmcTestMethodOriginTerminology
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.48.29

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

References

Logical Definition (CLD)

 

Expansion

Expansion based on codesystem PQ-CMC-FDA Temporary Codes v1.0.0-ballot (CodeSystem)

This value set contains 3 concepts.

CodeSystemDisplay
  C96164http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyCFR
  C96102http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyCompendial
  C96103http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyProprietary

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