## 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

Error | ValueSet.version | Values for version differ: '2.0.0-ballot' vs '2.0.0'
Information | ValueSet.date | Values for date differ: '2024-12-12T19:00:52+00:00' vs '2025-07-03T13:07:08+00:00'
Warning | ValueSet.compose.include[0].concept[0] | Code ich_3.2.s display changed from 'Drug Substance' to 'm3.2.s drug substance'
Warning | ValueSet.compose.include[0].concept[1] | Code ich_3.2.s.1 display changed from 'General Information' to 'm3.2.s.1 general information'
Warning | ValueSet.compose.include[0].concept[2] | Code ich_3.2.s.2 display changed from 'Manufacture' to 'm3.2.s.2 manufacture'
Warning | ValueSet.compose.include[0].concept[3] | Code ich_3.2.s.2.1 display changed from 'Manufacturers' to 'm3.2.s.2.1 manufacturer(s)'
Warning | ValueSet.compose.include[0].concept[4] | Code ich_3.2.s.2.2 display changed from 'Description of Manufacturing Process and Process Controls' to 'm3.2.s.2.2 description of manufacturing process and process controls'
Warning | ValueSet.compose.include[0].concept[5] | Code ich_3.2.s.2.3 display changed from 'Control of Materials' to 'm3.2.s.2.3 control of materials'
Warning | ValueSet.compose.include[0].concept[6] | Code ich_3.2.s.2.4 display changed from 'Controls of Critical Steps and Intermediates' to 'm3.2.s.2.4 controls of critical steps and intermediates'
Warning | ValueSet.compose.include[0].concept[7] | Code ich_3.2.s.2.5 display changed from 'Process Validation and/or Evaluation' to 'm3.2.s.2.5 process validation and/or evaluation'
Warning | ValueSet.compose.include[0].concept[8] | Code ich_3.2.s.2.6 display changed from 'Manufacturing Process Development' to 'm3.2.s.2.6 manufacturing process development'
Warning | ValueSet.compose.include[0].concept[9] | Code ich_3.2.s.3 display changed from 'Characterisation' to 'm3.2.s.3 characterisation'
Warning | ValueSet.compose.include[0].concept[10] | Code ich_3.2.s.3.1 display changed from 'Elucidation of Structure and other Characteristics' to 'm3.2.s.3.1 elucidation of structure and other characteristics'
Warning | ValueSet.compose.include[0].concept[11] | Code ich_3.2.s.3.2 display changed from 'Impurities' to 'm3.2.s.3.2 impurities'
Warning | ValueSet.compose.include[0].concept[12] | Code ich_3.2.s.4 display changed from 'Control of Drug Substance' to 'm3.2.s.4 control of drug substance'
Warning | ValueSet.compose.include[0].concept[13] | Code ich_3.2.s.4.1 display changed from 'Specification' to 'm3.2.s.4.1 specification'
Warning | ValueSet.compose.include[0].concept[14] | Code ich_3.2.s.4.2 display changed from 'Analytical Procedures' to 'm3.2.s.4.2 analytical procedures'
Warning | ValueSet.compose.include[0].concept[15] | Code ich_3.2.s.4.3 display changed from 'Validation of Analytical Procedures' to 'm3.2.s.4.3 validation of analytical procedures'
Warning | ValueSet.compose.include[0].concept[16] | Code ich_3.2.s.4.4 display changed from 'Batch Analyses' to 'm3.2.s.4.4 batch analyses'
Warning | ValueSet.compose.include[0].concept[17] | Code ich_3.2.s.4.5 display changed from 'Justification of Specification' to 'm3.2.s.4.5 justification of specification'
Warning | ValueSet.compose.include[0].concept[18] | Code ich_3.2.s.5 display changed from 'Reference Standards or Materials' to 'm3.2.s.5 reference standards or materials'
Warning | ValueSet.compose.include[0].concept[19] | Code ich_3.2.s.6 display changed from 'Container Closure System' to 'm3.2.s.6 container closure system'
Warning | ValueSet.compose.include[0].concept[20] | Code ich_3.2.s.7 display changed from 'Stability' to 'm3.2.s.7 stability'
Warning | ValueSet.compose.include[0].concept[21] | Code ich_3.2.s.7.1 display changed from 'Stability Summary and Conclusions' to 'm3.2.s.7.1 stability summary and conclusions'
Warning | ValueSet.compose.include[0].concept[22] | Code ich_3.2.s.7.2 display changed from 'Postapproval Stability Protocol and Stability Commitment' to 'm3.2.s.7.2 post-approval stability protocol and stability commitment'
Warning | ValueSet.compose.include[0].concept[23] | Code ich_3.2.s.7.3 display changed from 'Stability Data' to 'm3.2.s.7.3 stability data'
Warning | ValueSet.compose.include[0].concept[24] | Code ich_3.2.p display changed from 'Drug Product' to 'm3.2.p drug product'
Warning | ValueSet.compose.include[0].concept[25] | Code ich_3.2.p.1 display changed from 'Description and Composition of the Drug Product' to 'm3.2.p.1 description and composition of the drug product'
Warning | ValueSet.compose.include[0].concept[26] | Code ich_3.2.p.2 display changed from 'Pharmaceutical Development' to 'm3.2.p.2 pharmaceutical development'
Warning | ValueSet.compose.include[0].concept[27] | Code ich_3.2.p.2.1 display changed from 'Components of the Drug Product' to 'm3.2.p.2.1 components of the drug product'
Warning | ValueSet.compose.include[0].concept[28] | Code ich_3.2.p.2.2 display changed from 'Drug Product' to 'm3.2.p.2.2 drug product'
Warning | ValueSet.compose.include[0].concept[29] | Code ich_3.2.p.2.3 display changed from 'Manufacturing Process Development' to 'm3.2.p.2.3 manufacturing process development'
Warning | ValueSet.compose.include[0].concept[30] | Code ich_3.2.p.2.4 display changed from 'Container Closure System' to 'm3.2.p.2.4 container closure system'
Warning | ValueSet.compose.include[0].concept[31] | Code ich_3.2.p.2.5 display changed from 'Microbiological Attributes' to 'm3.2.p.2.5 microbiological attributes'
Warning | ValueSet.compose.include[0].concept[32] | Code ich_3.2.p.2.6 display changed from 'Compatibility' to 'm3.2.p.2.6 compatibility'
Warning | ValueSet.compose.include[0].concept[33] | Code ich_3.2.p.3 display changed from 'Manufacture' to 'm3.2.p.3 manufacture'
Warning | ValueSet.compose.include[0].concept[34] | Code ich_3.2.p.3.1 display changed from 'Manufacturer(s)' to 'm3.2.p.3.1 manufacturer(s)'
Warning | ValueSet.compose.include[0].concept[35] | Code ich_3.2.p.3.2 display changed from 'Batch Formula' to 'm3.2.p.3.2 batch formula'
Warning | ValueSet.compose.include[0].concept[36] | Code ich_3.2.p.3.3 display changed from 'Description of Manufacturing Process and Process Controls' to 'm3.2.p.3.3 description of manufacturing process and process controls'
Warning | ValueSet.compose.include[0].concept[37] | Code ich_3.2.p.3.4 display changed from 'Controls of Critical Steps and Intermediates' to 'm3.2.p.3.4 controls of critical steps and intermediates'
Warning | ValueSet.compose.include[0].concept[38] | Code ich_3.2.p.3.5 display changed from 'Process Validation and/or Evaluation' to 'm3.2.p.3.5 process validation and/or evaluation'
Warning | ValueSet.compose.include[0].concept[39] | Code ich_3.2.p.4 display changed from 'Control of Excipients' to 'm3.2.p.4 control of excipients'
Warning | ValueSet.compose.include[0].concept[40] | Code ich_3.2.p.4.1 display changed from 'Specification' to 'm3.2.p.4.1 specifications'
Warning | ValueSet.compose.include[0].concept[41] | Code ich_3.2.p.4.2 display changed from 'Analytical Procedures' to 'm3.2.p.4.2 analytical procedures'
Warning | ValueSet.compose.include[0].concept[42] | Code ich_3.2.p.4.3 display changed from 'Validation of Analytical Procedures' to 'm3.2.p.4.3 validation of analytical procedures'
Warning | ValueSet.compose.include[0].concept[43] | Code ich_3.2.p.4.4 display changed from 'Justification of Specifications' to 'm3.2.p.4.4 justification of specifications'
Warning | ValueSet.compose.include[0].concept[44] | Code ich_3.2.p.4.5 display changed from 'Excipients of Human or Animal Origin' to 'm3.2.p.4.5 excipients of human or animal origin'
Warning | ValueSet.compose.include[0].concept[45] | Code ich_3.2.p.4.6 display changed from 'Novel Excipients' to 'm3.2.p.4.6 novel excipients'
Warning | ValueSet.compose.include[0].concept[46] | Code ich_3.2.p.5 display changed from 'Control of Drug Product' to 'm3.2.p.5 control of drug product'
Warning | ValueSet.compose.include[0].concept[47] | Code ich_3.2.p.5.1 display changed from 'Specification(s)' to 'm3.2.p.5.1 specification(s)'
Warning | ValueSet.compose.include[0].concept[48] | Code ich_3.2.p.5.2 display changed from 'Analytical Procedures' to 'm3.2.p.5.2 analytical procedures'
Warning | ValueSet.compose.include[0].concept[49] | Code ich_3.2.p.5.3 display changed from 'Validation of Analytical Procedures' to 'm3.2.p.5.3 validation of analytical procedures'
Warning | ValueSet.compose.include[0].concept[50] | Code ich_3.2.p.5.4 display changed from 'Batch Analyses' to 'm3.2.p.5.4 batch analyses'
Warning | ValueSet.compose.include[0].concept[51] | Code ich_3.2.p.5.5 display changed from 'Characterisation of Impurities' to 'm3.2.p.5.5 characterisation of impurities'
Warning | ValueSet.compose.include[0].concept[52] | Code ich_3.2.p.5.6 display changed from 'Justification of Specifications' to 'm3.2.p.5.6 justification of specifications'
Warning | ValueSet.compose.include[0].concept[53] | Code ich_3.2.p.6 display changed from 'Reference Standards or Materials' to 'm3.2.p.6 reference standards or materials'
Warning | ValueSet.compose.include[0].concept[54] | Code ich_3.2.p.7 display changed from 'Container Closure System' to 'm3.2.p.7 container closure system'
Warning | ValueSet.compose.include[0].concept[55] | Code ich_3.2.p.8 display changed from 'Stability' to 'm3.2.p.8 stability'
Warning | ValueSet.compose.include[0].concept[56] | Code ich_3.2.p.8.1 display changed from 'Stability Summary and Conclusion' to 'm3.2.p.8.1 stability summary and conclusion'
Warning | ValueSet.compose.include[0].concept[57] | Code ich_3.2.p.8.2 display changed from 'Postapproval Stability Protocol and Stability Commitment' to 'm3.2.p.8.2 post-approval stability protocol and stability commitment'
Warning | ValueSet.compose.include[0].concept[58] | Code ich_3.2.p.8.3 display changed from 'Stability Data' to 'm3.2.p.8.3 stability data'
Warning | ValueSet.compose.include[0].concept[59] | Code ich_3.2.a display changed from 'Appendices' to 'm3.2.a appendices'
Warning | ValueSet.compose.include[0].concept[60] | Code ich_3.2.a.1 display changed from 'Facilities And Equipment' to 'm3.2.a.1 facilities and equipment'
Warning | ValueSet.compose.include[0].concept[61] | Code ich_3.2.a.2 display changed from 'Adventitious Agents Safety Evaluation' to 'm3.2.a.2 adventitious agents safety evaluation'
Warning | ValueSet.compose.include[0].concept[62] | Code ich_3.2.a.3 display changed from 'Excipients' to 'm3.2.a.3 excipients'
Warning | ValueSet.compose.include[0].concept[63] | Code ich_3.2.r display changed from 'Regional Information' to 'm3.2 r regional information'
Warning | ValueSet.compose.include[0].concept[64] | Code ich_3.3 display changed from 'Literature References' to 'm3.3 literature references'

### Metadata

Name | Value | Comments
--- | --- | ---
compose.inactive |  |
compose.lockedDate |  |
copyright |  |
date | 2024-12-12T19:00:52+00:00 | 2025-07-03T13:07:08+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

Unable to generate expansion - see errors