Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI United States of America flag

Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 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/ and changes regularly. See the Directory of published versions

CodeSystem: Code System PQCMC Comp Section Types

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types Version: 0.1.20
Draft as of 2024-03-04 Computable Name: PqcmcCompSectionTypes

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.

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

This case-sensitive code system http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types defines the following codes:

CodeDisplay
32S10 Substance General Information
32S11 Substance Nomenclature
32S12 Substance Structure
32S13 Substance General Properties
32S20 Substance Manufacture
32S21 Substance Manufacturers
32S22 Substance Description of Manufacturing Process and Process Controls
32S23 Substance Control of Materials
32S231 Raw Material Specification
32S24 Substance Controls of Critical Steps and Intermediates
32S25 Substance Process Validation and/or Evaluation
32S26 Substance Manufacturing Process Development
32S30 Substance Characterization
32S31 Substance Elucidation of Structure and other Characteristics
32S32 Substance Impurities
32S40 Substance Control of Drug Substance
32S41 Substance Specification
32S42 Substance Analytical Procedures
32S43 Substance Validation of Analytical Procedures
32S44 Substance Batch Analyses
32S45 Substance Justification of Specification
32S50 Substance Reference Standards or Materials
32S60 Substance Container Closure System
32S70 Substance Stability
32S71 Substance Stability Summary and Conclusions
32S72 Substance Postapproval Stability Protocol and Stability Commitment
32S73 Substance Stability Data
32P10 Product Description and Composition of the Drug Product
32P11 Product Description
32P12 Product Composition
32P13 Product Container Closure Description
32P20 Product Pharmaceutical Development
32P21 Product Components of the Drug Product
32P22 Product Drug Product
32P23 Product Manufacturing Process Development
32P24 Product Container Closure System
32P25 Product Microbiological Attributes
32P26 Product Compatibility
32P30 Product Manufacture
32P31 Product Manufacturers
32P32 Product Batch Formula
32P33 Product Description of Manufacturing Process and Process Controls
32P34 Product Controls of Critical Steps and Intermediates
32P35 Product Process Validation and/or Evaluation
32P40 Product Control of Excipients
32P41 Excipients Specification
32P42 Product Analytical Procedures
32P43 Product Validation of Analytical Procedures
32P44 Product Justification of Specifications
32P45 Product Excipients of Human or Animal Origin
32P46 Product Novel Excipients
32P50 Product name dosage form
32P51 Product Specification
32P52 Product Analytical Procedures
32P53 Product Validation of Analytical Procedures
32P54 Product Batch Analyses
32P55 Product Characterization of Impurities
32P56 Product Justification of Specifications
32P60 Product Reference Standards or Materials
32P70 Product Container Closure System
32P80 Product Stability
32P81 Product Stability Summary and Conclusion
32P82 Product Postapproval Stability Protocol and Stability Commitment
32P83 Product Stability Data
SP4151 Quality Specification
SP4454 Batch Analyses
SP7383 Stability Data
SP7181 Stability Summary and Conclusion