Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

ValueSet: Batch utilization Terminology

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology Version: 1.0.0
Active as of 2024-12-11 Computable Name: PqcmcBatchUtilizationTerminology
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.48.35

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

References

This value set is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)

Logical Definition (CLD)

Generated Narrative: ValueSet pqcmc-batch-utilization-terminology

 

Expansion

Generated Narrative: ValueSet

Expansion based on supplement PQ-CMC-FDA NCIt Hieararchy Supplement v1.0.0 (CodeSystem)

This value set contains 6 concepts

CodeSystemDisplay
  C133994http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlBioequivalence Batch
  C133992http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlClinical Batch
  C133990http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlCommercial Batch
  C133991http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlDevelopment Batch
  C133993http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlValidation Batch
  C185328http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlStability Study Batch

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