Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 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
Standards status: Trial-use | Maturity Level: 2 | 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

- Quality Specification

### Logical Definition (CLD)

- Include these codes as defined in `http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl`

  Code | Display
  C134021 | Drug Product
  C134022 | Drug Substance
  C133931 | Raw Materials/Excipients/Intermediates/Reagents

### Expansion

Expansion from tx.fhir.org based on supplement PQ-CMC-FDA NCIt Hierarchy Supplement v2.0.0 (CodeSystem)

This value set contains 3 concepts

Code | System | Display (en-US)
C134021 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Drug Product Specification
C134022 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Drug Substance Specification
C133931 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Raw 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