ValueSet Comparison between http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs vs http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs

Messages

Metadata

Name	Value		Comments
compose.inactive
compose.lockedDate
copyright
date	2024-12-12T19:00:52+00:00	2025-07-08T07:43:10+00:00	Values Differ
description	Value set of all codes in Code system PQCMC Comp Section Types.
experimental	false
immutable
jurisdiction
jurisdiction[0]	urn:iso:std:iso:3166#US
name	CmcCompSectionTypesVS
publisher	HL7 International / Biomedical Research and Regulation
purpose
status	active
title	eCTD sections Terminology
url	http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs
version	2.0.0-ballot	2.0.0	Values Differ

Definition

Item	Property		Value		Comments
include	http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use	http://terminology.hl7.org/CodeSystem/ICHContextOfUse
Concept	ich_3.2.s		Drug Substance	m3.2.s drug substance
Concept	ich_3.2.s.1		General Information	m3.2.s.1 general information
Concept	ich_3.2.s.2		Manufacture	m3.2.s.2 manufacture
Concept	ich_3.2.s.2.1		Manufacturers	m3.2.s.2.1 manufacturer(s)
Concept	ich_3.2.s.2.2		Description of Manufacturing Process and Process Controls	m3.2.s.2.2 description of manufacturing process and process controls
Concept	ich_3.2.s.2.3		Control of Materials	m3.2.s.2.3 control of materials
Concept	ich_3.2.s.2.4		Controls of Critical Steps and Intermediates	m3.2.s.2.4 controls of critical steps and intermediates
Concept	ich_3.2.s.2.5		Process Validation and/or Evaluation	m3.2.s.2.5 process validation and/or evaluation
Concept	ich_3.2.s.2.6		Manufacturing Process Development	m3.2.s.2.6 manufacturing process development
Concept	ich_3.2.s.3		Characterisation	m3.2.s.3 characterisation
Concept	ich_3.2.s.3.1		Elucidation of Structure and other Characteristics	m3.2.s.3.1 elucidation of structure and other characteristics
Concept	ich_3.2.s.3.2		Impurities	m3.2.s.3.2 impurities
Concept	ich_3.2.s.4		Control of Drug Substance	m3.2.s.4 control of drug substance
Concept	ich_3.2.s.4.1		Specification	m3.2.s.4.1 specification
Concept	ich_3.2.s.4.2		Analytical Procedures	m3.2.s.4.2 analytical procedures
Concept	ich_3.2.s.4.3		Validation of Analytical Procedures	m3.2.s.4.3 validation of analytical procedures
Concept	ich_3.2.s.4.4		Batch Analyses	m3.2.s.4.4 batch analyses
Concept	ich_3.2.s.4.5		Justification of Specification	m3.2.s.4.5 justification of specification
Concept	ich_3.2.s.5		Reference Standards or Materials	m3.2.s.5 reference standards or materials
Concept	ich_3.2.s.6		Container Closure System	m3.2.s.6 container closure system
Concept	ich_3.2.s.7		Stability	m3.2.s.7 stability
Concept	ich_3.2.s.7.1		Stability Summary and Conclusions	m3.2.s.7.1 stability summary and conclusions
Concept	ich_3.2.s.7.2		Postapproval Stability Protocol and Stability Commitment	m3.2.s.7.2 post-approval stability protocol and stability commitment
Concept	ich_3.2.s.7.3		Stability Data	m3.2.s.7.3 stability data
Concept	ich_3.2.p		Drug Product	m3.2.p drug product
Concept	ich_3.2.p.1		Description and Composition of the Drug Product	m3.2.p.1 description and composition of the drug product
Concept	ich_3.2.p.2		Pharmaceutical Development	m3.2.p.2 pharmaceutical development
Concept	ich_3.2.p.2.1		Components of the Drug Product	m3.2.p.2.1 components of the drug product
Concept	ich_3.2.p.2.2		Drug Product	m3.2.p.2.2 drug product
Concept	ich_3.2.p.2.3		Manufacturing Process Development	m3.2.p.2.3 manufacturing process development
Concept	ich_3.2.p.2.4		Container Closure System	m3.2.p.2.4 container closure system
Concept	ich_3.2.p.2.5		Microbiological Attributes	m3.2.p.2.5 microbiological attributes
Concept	ich_3.2.p.2.6		Compatibility	m3.2.p.2.6 compatibility
Concept	ich_3.2.p.3		Manufacture	m3.2.p.3 manufacture
Concept	ich_3.2.p.3.1		Manufacturer(s)	m3.2.p.3.1 manufacturer(s)
Concept	ich_3.2.p.3.2		Batch Formula	m3.2.p.3.2 batch formula
Concept	ich_3.2.p.3.3		Description of Manufacturing Process and Process Controls	m3.2.p.3.3 description of manufacturing process and process controls
Concept	ich_3.2.p.3.4		Controls of Critical Steps and Intermediates	m3.2.p.3.4 controls of critical steps and intermediates
Concept	ich_3.2.p.3.5		Process Validation and/or Evaluation	m3.2.p.3.5 process validation and/or evaluation
Concept	ich_3.2.p.4		Control of Excipients	m3.2.p.4 control of excipients
Concept	ich_3.2.p.4.1		Specification	m3.2.p.4.1 specifications
Concept	ich_3.2.p.4.2		Analytical Procedures	m3.2.p.4.2 analytical procedures
Concept	ich_3.2.p.4.3		Validation of Analytical Procedures	m3.2.p.4.3 validation of analytical procedures
Concept	ich_3.2.p.4.4		Justification of Specifications	m3.2.p.4.4 justification of specifications
Concept	ich_3.2.p.4.5		Excipients of Human or Animal Origin	m3.2.p.4.5 excipients of human or animal origin
Concept	ich_3.2.p.4.6		Novel Excipients	m3.2.p.4.6 novel excipients
Concept	ich_3.2.p.5		Control of Drug Product	m3.2.p.5 control of drug product
Concept	ich_3.2.p.5.1		Specification(s)	m3.2.p.5.1 specification(s)
Concept	ich_3.2.p.5.2		Analytical Procedures	m3.2.p.5.2 analytical procedures
Concept	ich_3.2.p.5.3		Validation of Analytical Procedures	m3.2.p.5.3 validation of analytical procedures
Concept	ich_3.2.p.5.4		Batch Analyses	m3.2.p.5.4 batch analyses
Concept	ich_3.2.p.5.5		Characterisation of Impurities	m3.2.p.5.5 characterisation of impurities
Concept	ich_3.2.p.5.6		Justification of Specifications	m3.2.p.5.6 justification of specifications
Concept	ich_3.2.p.6		Reference Standards or Materials	m3.2.p.6 reference standards or materials
Concept	ich_3.2.p.7		Container Closure System	m3.2.p.7 container closure system
Concept	ich_3.2.p.8		Stability	m3.2.p.8 stability
Concept	ich_3.2.p.8.1		Stability Summary and Conclusion	m3.2.p.8.1 stability summary and conclusion
Concept	ich_3.2.p.8.2		Postapproval Stability Protocol and Stability Commitment	m3.2.p.8.2 post-approval stability protocol and stability commitment
Concept	ich_3.2.p.8.3		Stability Data	m3.2.p.8.3 stability data
Concept	ich_3.2.a		Appendices	m3.2.a appendices
Concept	ich_3.2.a.1		Facilities And Equipment	m3.2.a.1 facilities and equipment
Concept	ich_3.2.a.2		Adventitious Agents Safety Evaluation	m3.2.a.2 adventitious agents safety evaluation
Concept	ich_3.2.a.3		Excipients	m3.2.a.3 excipients
Concept	ich_3.2.r		Regional Information	m3.2 r regional information
Concept	ich_3.3		Literature References	m3.3 literature references

Expansion

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