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 Section Type Terminology

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-specification-types-vs | Version: 2.0.0
Standards status: Trial-use | Maturity Level: 2 | 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

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)

- Include these codes as defined in `http://terminology.hl7.org/CodeSystem/ICHContextOfUse`

  Code | Display
  ich_3.2.p.5.1 | m3.2.p.5.1 specification(s)
  ich_3.2.s.4.1 | m3.2.s.4.1 specification
  ich_3.2.p.4 | m3.2.p.4 control of excipients

### Expansion

This value set contains 3 concepts

Code | System | Display (en-US)
ich_3.2.p.5.1 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.5.1 specification(s)
ich_3.2.s.4.1 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.4.1 specification
ich_3.2.p.4 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.4 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