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: eCTD sections Terminology

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

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.s | m3.2.s drug substance
  ich_3.2.s.1 | m3.2.s.1 general information
  ich_3.2.s.2 | m3.2.s.2 manufacture
  ich_3.2.s.2.1 | m3.2.s.2.1 manufacturer(s)
  ich_3.2.s.2.2 | m3.2.s.2.2 description of manufacturing process and process controls
  ich_3.2.s.2.3 | m3.2.s.2.3 control of materials
  ich_3.2.s.2.4 | m3.2.s.2.4 controls of critical steps and intermediates
  ich_3.2.s.2.5 | m3.2.s.2.5 process validation and/or evaluation
  ich_3.2.s.2.6 | m3.2.s.2.6 manufacturing process development
  ich_3.2.s.3 | m3.2.s.3 characterisation
  ich_3.2.s.3.1 | m3.2.s.3.1 elucidation of structure and other characteristics
  ich_3.2.s.3.2 | m3.2.s.3.2 impurities
  ich_3.2.s.4 | m3.2.s.4 control of drug substance
  ich_3.2.s.4.1 | m3.2.s.4.1 specification
  ich_3.2.s.4.2 | m3.2.s.4.2 analytical procedures
  ich_3.2.s.4.3 | m3.2.s.4.3 validation of analytical procedures
  ich_3.2.s.4.4 | m3.2.s.4.4 batch analyses
  ich_3.2.s.4.5 | m3.2.s.4.5 justification of specification
  ich_3.2.s.5 | m3.2.s.5 reference standards or materials
  ich_3.2.s.6 | m3.2.s.6 container closure system
  ich_3.2.s.7 | m3.2.s.7 stability
  ich_3.2.s.7.1 | m3.2.s.7.1 stability summary and conclusions
  ich_3.2.s.7.2 | m3.2.s.7.2 post-approval stability protocol and stability commitment
  ich_3.2.s.7.3 | m3.2.s.7.3 stability data
  ich_3.2.p | m3.2.p drug product
  ich_3.2.p.1 | m3.2.p.1 description and composition of the drug product
  ich_3.2.p.2 | m3.2.p.2 pharmaceutical development
  ich_3.2.p.2.1 | m3.2.p.2.1 components of the drug product
  ich_3.2.p.2.2 | m3.2.p.2.2 drug product
  ich_3.2.p.2.3 | m3.2.p.2.3 manufacturing process development
  ich_3.2.p.2.4 | m3.2.p.2.4 container closure system
  ich_3.2.p.2.5 | m3.2.p.2.5 microbiological attributes
  ich_3.2.p.2.6 | m3.2.p.2.6 compatibility
  ich_3.2.p.3 | m3.2.p.3 manufacture
  ich_3.2.p.3.1 | m3.2.p.3.1 manufacturer(s)
  ich_3.2.p.3.2 | m3.2.p.3.2 batch formula
  ich_3.2.p.3.3 | m3.2.p.3.3 description of manufacturing process and process controls
  ich_3.2.p.3.4 | m3.2.p.3.4 controls of critical steps and intermediates
  ich_3.2.p.3.5 | m3.2.p.3.5 process validation and/or evaluation
  ich_3.2.p.4 | m3.2.p.4 control of excipients
  ich_3.2.p.4.1 | m3.2.p.4.1 specifications
  ich_3.2.p.4.2 | m3.2.p.4.2 analytical procedures
  ich_3.2.p.4.3 | m3.2.p.4.3 validation of analytical procedures
  ich_3.2.p.4.4 | m3.2.p.4.4 justification of specifications
  ich_3.2.p.4.5 | m3.2.p.4.5 excipients of human or animal origin
  ich_3.2.p.4.6 | m3.2.p.4.6 novel excipients
  ich_3.2.p.5 | m3.2.p.5 control of drug product
  ich_3.2.p.5.1 | m3.2.p.5.1 specification(s)
  ich_3.2.p.5.2 | m3.2.p.5.2 analytical procedures
  ich_3.2.p.5.3 | m3.2.p.5.3 validation of analytical procedures
  ich_3.2.p.5.4 | m3.2.p.5.4 batch analyses
  ich_3.2.p.5.5 | m3.2.p.5.5 characterisation of impurities
  ich_3.2.p.5.6 | m3.2.p.5.6 justification of specifications
  ich_3.2.p.6 | m3.2.p.6 reference standards or materials
  ich_3.2.p.7 | m3.2.p.7 container closure system
  ich_3.2.p.8 | m3.2.p.8 stability
  ich_3.2.p.8.1 | m3.2.p.8.1 stability summary and conclusion
  ich_3.2.p.8.2 | m3.2.p.8.2 post-approval stability protocol and stability commitment
  ich_3.2.p.8.3 | m3.2.p.8.3 stability data
  ich_3.2.a | m3.2.a appendices
  ich_3.2.a.1 | m3.2.a.1 facilities and equipment
  ich_3.2.a.2 | m3.2.a.2 adventitious agents safety evaluation
  ich_3.2.a.3 | m3.2.a.3 excipients
  ich_3.2.r | m3.2 r regional information
  ich_3.3 | m3.3 literature references

### Expansion

This value set contains 65 concepts

Code | System | Display (en-US)
ich_3.2.s | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s drug substance
ich_3.2.s.1 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.1 general information
ich_3.2.s.2 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.2 manufacture
ich_3.2.s.2.1 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.2.1 manufacturer(s)
ich_3.2.s.2.2 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.2.2 description of manufacturing process and process controls
ich_3.2.s.2.3 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.2.3 control of materials
ich_3.2.s.2.4 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.2.4 controls of critical steps and intermediates
ich_3.2.s.2.5 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.2.5 process validation and/or evaluation
ich_3.2.s.2.6 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.2.6 manufacturing process development
ich_3.2.s.3 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.3 characterisation
ich_3.2.s.3.1 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.3.1 elucidation of structure and other characteristics
ich_3.2.s.3.2 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.3.2 impurities
ich_3.2.s.4 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.4 control of drug substance
ich_3.2.s.4.1 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.4.1 specification
ich_3.2.s.4.2 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.4.2 analytical procedures
ich_3.2.s.4.3 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.4.3 validation of analytical procedures
ich_3.2.s.4.4 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.4.4 batch analyses
ich_3.2.s.4.5 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.4.5 justification of specification
ich_3.2.s.5 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.5 reference standards or materials
ich_3.2.s.6 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.6 container closure system
ich_3.2.s.7 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.7 stability
ich_3.2.s.7.1 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.7.1 stability summary and conclusions
ich_3.2.s.7.2 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.7.2 post-approval stability protocol and stability commitment
ich_3.2.s.7.3 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.s.7.3 stability data
ich_3.2.p | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p drug product
ich_3.2.p.1 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.1 description and composition of the drug product
ich_3.2.p.2 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.2 pharmaceutical development
ich_3.2.p.2.1 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.2.1 components of the drug product
ich_3.2.p.2.2 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.2.2 drug product
ich_3.2.p.2.3 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.2.3 manufacturing process development
ich_3.2.p.2.4 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.2.4 container closure system
ich_3.2.p.2.5 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.2.5 microbiological attributes
ich_3.2.p.2.6 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.2.6 compatibility
ich_3.2.p.3 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.3 manufacture
ich_3.2.p.3.1 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.3.1 manufacturer(s)
ich_3.2.p.3.2 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.3.2 batch formula
ich_3.2.p.3.3 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.3.3 description of manufacturing process and process controls
ich_3.2.p.3.4 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.3.4 controls of critical steps and intermediates
ich_3.2.p.3.5 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.3.5 process validation and/or evaluation
ich_3.2.p.4 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.4 control of excipients
ich_3.2.p.4.1 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.4.1 specifications
ich_3.2.p.4.2 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.4.2 analytical procedures
ich_3.2.p.4.3 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.4.3 validation of analytical procedures
ich_3.2.p.4.4 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.4.4 justification of specifications
ich_3.2.p.4.5 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.4.5 excipients of human or animal origin
ich_3.2.p.4.6 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.4.6 novel excipients
ich_3.2.p.5 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.5 control of drug product
ich_3.2.p.5.1 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.5.1 specification(s)
ich_3.2.p.5.2 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.5.2 analytical procedures
ich_3.2.p.5.3 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.5.3 validation of analytical procedures
ich_3.2.p.5.4 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.5.4 batch analyses
ich_3.2.p.5.5 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.5.5 characterisation of impurities
ich_3.2.p.5.6 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.5.6 justification of specifications
ich_3.2.p.6 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.6 reference standards or materials
ich_3.2.p.7 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.7 container closure system
ich_3.2.p.8 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.8 stability
ich_3.2.p.8.1 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.8.1 stability summary and conclusion
ich_3.2.p.8.2 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.8.2 post-approval stability protocol and stability commitment
ich_3.2.p.8.3 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.p.8.3 stability data
ich_3.2.a | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.a appendices
ich_3.2.a.1 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.a.1 facilities and equipment
ich_3.2.a.2 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.a.2 adventitious agents safety evaluation
ich_3.2.a.3 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2.a.3 excipients
ich_3.2.r | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.2 r regional information
ich_3.3 | http://terminology.hl7.org/CodeSystem/ICHContextOfUse | m3.3 literature references

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