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

• Narrative Content
• XML
• JSON

CodeSystem: Code System PQCMC Comp Section Types

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types				Version: 1.1.6
Draft as of 2024-09-22				Computable Name: PqcmcCompSectionTypes
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.16.4

Classification of a section of a PQ/CMC composition/document generally based on eCTD Module 3 section numbering for product and substance. A composition can have many section codes. Codes temporarily defined as part of the PQ-CMC-FDA implementation guide. These will eventually migrate into an officially maintained terminology (likely either NCIt or HL7's UTG code systems).

This Code system is referenced in the content logical definition of the following value sets:

• CmcCompSectionTypesVS
• PqcmcQualitySpecificationSectionTypes