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

ValueSet: eCTD sections Terminology

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs Version: 1.1.6
Draft as of 2024-09-22 Computable Name: CmcCompSectionTypesVS
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.48.2

Value set of all codes in Code system PQCMC Comp Section Types for bindings that require a value set instead of the code system.

References

Logical Definition (CLD)

Generated Narrative: ValueSet cmc-comp-section-types-vs

 

Expansion

Generated Narrative: ValueSet

Expansion based on codesystem Code System PQCMC Comp Section Types v1.1.6 (CodeSystem)

This value set contains 68 concepts

CodeSystemDisplay
  32S10http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance General Information
  32S11http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Nomenclature
  32S12http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Structure
  32S13http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance General Properties
  32S20http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Manufacture
  32S21http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Manufacturers
  32S22http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Description of Manufacturing Process and Process Controls
  32S23http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Control of Materials
  32S231http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesRaw Material Specification
  32S24http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Controls of Critical Steps and Intermediates
  32S25http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Process Validation and/or Evaluation
  32S26http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Manufacturing Process Development
  32S3http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Characterisation
  32S31http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Elucidation of Structure and other Characteristics
  32S32http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Impurities
  32S40http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Control of Drug Substance
  32S41http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Specification
  32S42http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Analytical Procedures
  32S43http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Validation of Analytical Procedures
  32S44http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Batch Analyses
  32S45http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Justification of Specification
  32S50http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Reference Standards or Materials
  32S60http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Container Closure System
  32S70http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Stability
  32S71http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Stability Summary and Conclusions
  32S72http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Postapproval Stability Protocol and Stability Commitment
  32S73http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesSubstance Stability Data
  32P10http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Description and Composition of the Drug Product
  32P11http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Description
  32P12http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Composition
  32P13http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Container Closure Description
  32P20http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Pharmaceutical Development
  32P21http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Components of the Drug Product
  32P22http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Drug Product
  32P23http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Manufacturing Process Development
  32P24http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Container Closure System
  32P25http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Microbiological Attributes
  32P26http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Compatibility
  32P30http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Manufacture
  32P31http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Manufacturers
  32P32http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Batch Formula
  32P33http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Description of Manufacturing Process and Process Controls
  32P34http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Controls of Critical Steps and Intermediates
  32P35http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Process Validation and/or Evaluation
  32P40http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Control of Excipients
  32P41http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesExcipients Specification
  32P42http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Analytical Procedures
  32P43http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Validation of Analytical Procedures
  32P44http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Justification of Specifications
  32P45http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Excipients of Human or Animal Origin
  32P46http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Novel Excipients
  32P50http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct name dosage form
  32P51http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Specification
  32P52http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Analytical Procedures
  32P53http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Validation of Analytical Procedures
  32P54http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Batch Analyses
  32P55http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Characterisation of Impurities
  32P56http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Justification of Specifications
  32P60http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Reference Standards or Materials
  32P70http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Container Closure System
  32P80http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Stability
  32P81http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Stability Summary and Conclusion
  32P82http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Postapproval Stability Protocol and Stability Commitment
  32P83http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesProduct Stability Data
  SP4151http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesQuality Specification
  SP4454http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesBatch Analyses
  SP7383http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesStability Data
  SP7181http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-typesStability Summary and Conclusion

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