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Resource ValueSet/FHIR Server from package hl7.fhir.us.pq-cmc-fda#current (109 ms)

Package hl7.fhir.us.pq-cmc-fda
Type ValueSet
Id Id
FHIR Version R5
Source http://hl7.org/fhir/us/pq-cmc-fda/https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda/ValueSet-cmc-comp-section-types-vs.html
Url http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs
Version 2.0.0
Status active
Date 2025-06-19T20:23:28+00:00
Name CmcCompSectionTypesVS
Title eCTD sections Terminology
Experimental False
Realm us
Authority hl7
Description Value set of all codes in Code system PQCMC Comp Section Types.

Resources that use this resource

No resources found


Resources that this resource uses

CodeSystem
http://terminology.hl7.org/CodeSystem/ICHContextOfUse ICH Context of Use
http://terminology.hl7.org/CodeSystem/ICHContextOfUse ICH Context of Use


Narrative

Note: links and images are rebased to the (stated) source

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

  • Include these codes as defined in http://terminology.hl7.org/CodeSystem/ICHContextOfUse
    CodeDisplay
    ich_3.2.sm3.2.s drug substance
    ich_3.2.s.1m3.2.s.1 general information
    ich_3.2.s.2m3.2.s.2 manufacture
    ich_3.2.s.2.1m3.2.s.2.1 manufacturer(s)
    ich_3.2.s.2.2m3.2.s.2.2 description of manufacturing process and process controls
    ich_3.2.s.2.3m3.2.s.2.3 control of materials
    ich_3.2.s.2.4m3.2.s.2.4 controls of critical steps and intermediates
    ich_3.2.s.2.5m3.2.s.2.5 process validation and/or evaluation
    ich_3.2.s.2.6m3.2.s.2.6 manufacturing process development
    ich_3.2.s.3m3.2.s.3 characterisation
    ich_3.2.s.3.1m3.2.s.3.1 elucidation of structure and other characteristics
    ich_3.2.s.3.2m3.2.s.3.2 impurities
    ich_3.2.s.4m3.2.s.4 control of drug substance
    ich_3.2.s.4.1m3.2.s.4.1 specification
    ich_3.2.s.4.2m3.2.s.4.2 analytical procedures
    ich_3.2.s.4.3m3.2.s.4.3 validation of analytical procedures
    ich_3.2.s.4.4m3.2.s.4.4 batch analyses
    ich_3.2.s.4.5m3.2.s.4.5 justification of specification
    ich_3.2.s.5m3.2.s.5 reference standards or materials
    ich_3.2.s.6m3.2.s.6 container closure system
    ich_3.2.s.7m3.2.s.7 stability
    ich_3.2.s.7.1m3.2.s.7.1 stability summary and conclusions
    ich_3.2.s.7.2m3.2.s.7.2 post-approval stability protocol and stability commitment
    ich_3.2.s.7.3m3.2.s.7.3 stability data
    ich_3.2.pm3.2.p drug product
    ich_3.2.p.1m3.2.p.1 description and composition of the drug product
    ich_3.2.p.2m3.2.p.2 pharmaceutical development
    ich_3.2.p.2.1m3.2.p.2.1 components of the drug product
    ich_3.2.p.2.2m3.2.p.2.2 drug product
    ich_3.2.p.2.3m3.2.p.2.3 manufacturing process development
    ich_3.2.p.2.4m3.2.p.2.4 container closure system
    ich_3.2.p.2.5m3.2.p.2.5 microbiological attributes
    ich_3.2.p.2.6m3.2.p.2.6 compatibility
    ich_3.2.p.3m3.2.p.3 manufacture
    ich_3.2.p.3.1m3.2.p.3.1 manufacturer(s)
    ich_3.2.p.3.2m3.2.p.3.2 batch formula
    ich_3.2.p.3.3m3.2.p.3.3 description of manufacturing process and process controls
    ich_3.2.p.3.4m3.2.p.3.4 controls of critical steps and intermediates
    ich_3.2.p.3.5m3.2.p.3.5 process validation and/or evaluation
    ich_3.2.p.4m3.2.p.4 control of excipients
    ich_3.2.p.4.1m3.2.p.4.1 specifications
    ich_3.2.p.4.2m3.2.p.4.2 analytical procedures
    ich_3.2.p.4.3m3.2.p.4.3 validation of analytical procedures
    ich_3.2.p.4.4m3.2.p.4.4 justification of specifications
    ich_3.2.p.4.5m3.2.p.4.5 excipients of human or animal origin
    ich_3.2.p.4.6m3.2.p.4.6 novel excipients
    ich_3.2.p.5m3.2.p.5 control of drug product
    ich_3.2.p.5.1m3.2.p.5.1 specification(s)
    ich_3.2.p.5.2m3.2.p.5.2 analytical procedures
    ich_3.2.p.5.3m3.2.p.5.3 validation of analytical procedures
    ich_3.2.p.5.4m3.2.p.5.4 batch analyses
    ich_3.2.p.5.5m3.2.p.5.5 characterisation of impurities
    ich_3.2.p.5.6m3.2.p.5.6 justification of specifications
    ich_3.2.p.6m3.2.p.6 reference standards or materials
    ich_3.2.p.7m3.2.p.7 container closure system
    ich_3.2.p.8m3.2.p.8 stability
    ich_3.2.p.8.1m3.2.p.8.1 stability summary and conclusion
    ich_3.2.p.8.2m3.2.p.8.2 post-approval stability protocol and stability commitment
    ich_3.2.p.8.3m3.2.p.8.3 stability data
    ich_3.2.am3.2.a appendices
    ich_3.2.a.1m3.2.a.1 facilities and equipment
    ich_3.2.a.2m3.2.a.2 adventitious agents safety evaluation
    ich_3.2.a.3m3.2.a.3 excipients
    ich_3.2.rm3.2 r regional information
    ich_3.3m3.3 literature references

Source

{
  "resourceType" : "ValueSet",
  "id" : "cmc-comp-section-types-vs",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet cmc-comp-section-types-vs</b></p><a name=\"cmc-comp-section-types-vs\"> </a><a name=\"hccmc-comp-section-types-vs\"> </a><ul><li>Include these codes as defined in <a href=\"http://terminology.hl7.org/6.4.0/CodeSystem-ICHContextOfUse.html\"><code>http://terminology.hl7.org/CodeSystem/ICHContextOfUse</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>ich_3.2.s</td><td>m3.2.s drug substance</td></tr><tr><td>ich_3.2.s.1</td><td>m3.2.s.1 general information</td></tr><tr><td>ich_3.2.s.2</td><td>m3.2.s.2 manufacture</td></tr><tr><td>ich_3.2.s.2.1</td><td>m3.2.s.2.1 manufacturer(s)</td></tr><tr><td>ich_3.2.s.2.2</td><td>m3.2.s.2.2 description of manufacturing process and process controls</td></tr><tr><td>ich_3.2.s.2.3</td><td>m3.2.s.2.3 control of materials</td></tr><tr><td>ich_3.2.s.2.4</td><td>m3.2.s.2.4 controls of critical steps and intermediates</td></tr><tr><td>ich_3.2.s.2.5</td><td>m3.2.s.2.5 process validation and/or evaluation</td></tr><tr><td>ich_3.2.s.2.6</td><td>m3.2.s.2.6 manufacturing process development</td></tr><tr><td>ich_3.2.s.3</td><td>m3.2.s.3 characterisation</td></tr><tr><td>ich_3.2.s.3.1</td><td>m3.2.s.3.1 elucidation of structure and other characteristics</td></tr><tr><td>ich_3.2.s.3.2</td><td>m3.2.s.3.2 impurities</td></tr><tr><td>ich_3.2.s.4</td><td>m3.2.s.4 control of drug substance</td></tr><tr><td>ich_3.2.s.4.1</td><td>m3.2.s.4.1 specification</td></tr><tr><td>ich_3.2.s.4.2</td><td>m3.2.s.4.2 analytical procedures</td></tr><tr><td>ich_3.2.s.4.3</td><td>m3.2.s.4.3 validation of analytical procedures</td></tr><tr><td>ich_3.2.s.4.4</td><td>m3.2.s.4.4 batch analyses</td></tr><tr><td>ich_3.2.s.4.5</td><td>m3.2.s.4.5 justification of specification</td></tr><tr><td>ich_3.2.s.5</td><td>m3.2.s.5 reference standards or materials</td></tr><tr><td>ich_3.2.s.6</td><td>m3.2.s.6 container closure system</td></tr><tr><td>ich_3.2.s.7</td><td>m3.2.s.7 stability</td></tr><tr><td>ich_3.2.s.7.1</td><td>m3.2.s.7.1 stability summary and conclusions</td></tr><tr><td>ich_3.2.s.7.2</td><td>m3.2.s.7.2 post-approval stability protocol and stability commitment</td></tr><tr><td>ich_3.2.s.7.3</td><td>m3.2.s.7.3 stability data</td></tr><tr><td>ich_3.2.p</td><td>m3.2.p drug product</td></tr><tr><td>ich_3.2.p.1</td><td>m3.2.p.1 description and composition of the drug product</td></tr><tr><td>ich_3.2.p.2</td><td>m3.2.p.2 pharmaceutical development</td></tr><tr><td>ich_3.2.p.2.1</td><td>m3.2.p.2.1 components of the drug product</td></tr><tr><td>ich_3.2.p.2.2</td><td>m3.2.p.2.2 drug product</td></tr><tr><td>ich_3.2.p.2.3</td><td>m3.2.p.2.3 manufacturing process development</td></tr><tr><td>ich_3.2.p.2.4</td><td>m3.2.p.2.4 container closure system</td></tr><tr><td>ich_3.2.p.2.5</td><td>m3.2.p.2.5 microbiological attributes</td></tr><tr><td>ich_3.2.p.2.6</td><td>m3.2.p.2.6 compatibility</td></tr><tr><td>ich_3.2.p.3</td><td>m3.2.p.3 manufacture</td></tr><tr><td>ich_3.2.p.3.1</td><td>m3.2.p.3.1 manufacturer(s)</td></tr><tr><td>ich_3.2.p.3.2</td><td>m3.2.p.3.2 batch formula</td></tr><tr><td>ich_3.2.p.3.3</td><td>m3.2.p.3.3 description of manufacturing process and process controls</td></tr><tr><td>ich_3.2.p.3.4</td><td>m3.2.p.3.4 controls of critical steps and intermediates</td></tr><tr><td>ich_3.2.p.3.5</td><td>m3.2.p.3.5 process validation and/or evaluation</td></tr><tr><td>ich_3.2.p.4</td><td>m3.2.p.4 control of excipients</td></tr><tr><td>ich_3.2.p.4.1</td><td>m3.2.p.4.1 specifications</td></tr><tr><td>ich_3.2.p.4.2</td><td>m3.2.p.4.2 analytical procedures</td></tr><tr><td>ich_3.2.p.4.3</td><td>m3.2.p.4.3 validation of analytical procedures</td></tr><tr><td>ich_3.2.p.4.4</td><td>m3.2.p.4.4 justification of specifications</td></tr><tr><td>ich_3.2.p.4.5</td><td>m3.2.p.4.5 excipients of human or animal origin</td></tr><tr><td>ich_3.2.p.4.6</td><td>m3.2.p.4.6 novel excipients</td></tr><tr><td>ich_3.2.p.5</td><td>m3.2.p.5 control of drug product</td></tr><tr><td>ich_3.2.p.5.1</td><td>m3.2.p.5.1 specification(s)</td></tr><tr><td>ich_3.2.p.5.2</td><td>m3.2.p.5.2 analytical procedures</td></tr><tr><td>ich_3.2.p.5.3</td><td>m3.2.p.5.3 validation of analytical procedures</td></tr><tr><td>ich_3.2.p.5.4</td><td>m3.2.p.5.4 batch analyses</td></tr><tr><td>ich_3.2.p.5.5</td><td>m3.2.p.5.5 characterisation of impurities</td></tr><tr><td>ich_3.2.p.5.6</td><td>m3.2.p.5.6 justification of specifications</td></tr><tr><td>ich_3.2.p.6</td><td>m3.2.p.6 reference standards or materials</td></tr><tr><td>ich_3.2.p.7</td><td>m3.2.p.7 container closure system</td></tr><tr><td>ich_3.2.p.8</td><td>m3.2.p.8 stability</td></tr><tr><td>ich_3.2.p.8.1</td><td>m3.2.p.8.1 stability summary and conclusion</td></tr><tr><td>ich_3.2.p.8.2</td><td>m3.2.p.8.2 post-approval stability protocol and stability commitment</td></tr><tr><td>ich_3.2.p.8.3</td><td>m3.2.p.8.3 stability data</td></tr><tr><td>ich_3.2.a</td><td>m3.2.a appendices</td></tr><tr><td>ich_3.2.a.1</td><td>m3.2.a.1 facilities and equipment</td></tr><tr><td>ich_3.2.a.2</td><td>m3.2.a.2 adventitious agents safety evaluation</td></tr><tr><td>ich_3.2.a.3</td><td>m3.2.a.3 excipients</td></tr><tr><td>ich_3.2.r</td><td>m3.2 r regional information</td></tr><tr><td>ich_3.3</td><td>m3.3 literature references</td></tr></table></li></ul></div>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode" : "brr"
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger" : 2,
      "_valueInteger" : {
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical" : "http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"
          }
        ]
      }
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode" : "trial-use",
      "_valueCode" : {
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical" : "http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"
          }
        ]
      }
    }
  ],
  "url" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs",
  "identifier" : [
    {
      "system" : "urn:ietf:rfc:3986",
      "value" : "urn:oid:2.16.840.1.113883.4.642.40.36.48.2"
    }
  ],
  "version" : "2.0.0",
  "name" : "CmcCompSectionTypesVS",
  "title" : "eCTD sections Terminology",
  "status" : "active",
  "experimental" : false,
  "date" : "2025-06-19T20:23:28+00:00",
  "publisher" : "HL7 International / Biomedical Research and Regulation",
  "contact" : [
    {
      "name" : "HL7 International / Biomedical Research and Regulation",
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://www.hl7.org/Special/committees/rcrim"
        },
        {
          "system" : "email",
          "value" : "brr@lists.HL7.org"
        }
      ]
    }
  ],
  "description" : "Value set of all codes in Code system PQCMC Comp Section Types.",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "urn:iso:std:iso:3166",
          "code" : "US",
          "display" : "United States of America"
        }
      ]
    }
  ],
  "compose" : {
    "include" : [
      {
        "system" : "http://terminology.hl7.org/CodeSystem/ICHContextOfUse",
        "concept" : [
          {
            "code" : "ich_3.2.s",
            "display" : "m3.2.s drug substance"
          },
          {
            "code" : "ich_3.2.s.1",
            "display" : "m3.2.s.1 general information"
          },
          {
            "code" : "ich_3.2.s.2",
            "display" : "m3.2.s.2 manufacture"
          },
          {
            "code" : "ich_3.2.s.2.1",
            "display" : "m3.2.s.2.1 manufacturer(s)"
          },
          {
            "code" : "ich_3.2.s.2.2",
            "display" : "m3.2.s.2.2 description of manufacturing process and process controls"
          },
          {
            "code" : "ich_3.2.s.2.3",
            "display" : "m3.2.s.2.3 control of materials"
          },
          {
            "code" : "ich_3.2.s.2.4",
            "display" : "m3.2.s.2.4 controls of critical steps and intermediates"
          },
          {
            "code" : "ich_3.2.s.2.5",
            "display" : "m3.2.s.2.5 process validation and/or evaluation"
          },
          {
            "code" : "ich_3.2.s.2.6",
            "display" : "m3.2.s.2.6 manufacturing process development"
          },
          {
            "code" : "ich_3.2.s.3",
            "display" : "m3.2.s.3 characterisation"
          },
          {
            "code" : "ich_3.2.s.3.1",
            "display" : "m3.2.s.3.1 elucidation of structure and other characteristics"
          },
          {
            "code" : "ich_3.2.s.3.2",
            "display" : "m3.2.s.3.2 impurities"
          },
          {
            "code" : "ich_3.2.s.4",
            "display" : "m3.2.s.4 control of drug substance"
          },
          {
            "code" : "ich_3.2.s.4.1",
            "display" : "m3.2.s.4.1 specification"
          },
          {
            "code" : "ich_3.2.s.4.2",
            "display" : "m3.2.s.4.2 analytical procedures"
          },
          {
            "code" : "ich_3.2.s.4.3",
            "display" : "m3.2.s.4.3 validation of analytical procedures"
          },
          {
            "code" : "ich_3.2.s.4.4",
            "display" : "m3.2.s.4.4 batch analyses"
          },
          {
            "code" : "ich_3.2.s.4.5",
            "display" : "m3.2.s.4.5 justification of specification"
          },
          {
            "code" : "ich_3.2.s.5",
            "display" : "m3.2.s.5 reference standards or materials"
          },
          {
            "code" : "ich_3.2.s.6",
            "display" : "m3.2.s.6 container closure system"
          },
          {
            "code" : "ich_3.2.s.7",
            "display" : "m3.2.s.7 stability"
          },
          {
            "code" : "ich_3.2.s.7.1",
            "display" : "m3.2.s.7.1 stability summary and conclusions"
          },
          {
            "code" : "ich_3.2.s.7.2",
            "display" : "m3.2.s.7.2 post-approval stability protocol and stability commitment"
          },
          {
            "code" : "ich_3.2.s.7.3",
            "display" : "m3.2.s.7.3 stability data"
          },
          {
            "code" : "ich_3.2.p",
            "display" : "m3.2.p drug product"
          },
          {
            "code" : "ich_3.2.p.1",
            "display" : "m3.2.p.1 description and composition of the drug product"
          },
          {
            "code" : "ich_3.2.p.2",
            "display" : "m3.2.p.2 pharmaceutical development"
          },
          {
            "code" : "ich_3.2.p.2.1",
            "display" : "m3.2.p.2.1 components of the drug product"
          },
          {
            "code" : "ich_3.2.p.2.2",
            "display" : "m3.2.p.2.2 drug product"
          },
          {
            "code" : "ich_3.2.p.2.3",
            "display" : "m3.2.p.2.3 manufacturing process development"
          },
          {
            "code" : "ich_3.2.p.2.4",
            "display" : "m3.2.p.2.4 container closure system"
          },
          {
            "code" : "ich_3.2.p.2.5",
            "display" : "m3.2.p.2.5 microbiological attributes"
          },
          {
            "code" : "ich_3.2.p.2.6",
            "display" : "m3.2.p.2.6 compatibility"
          },
          {
            "code" : "ich_3.2.p.3",
            "display" : "m3.2.p.3 manufacture"
          },
          {
            "code" : "ich_3.2.p.3.1",
            "display" : "m3.2.p.3.1 manufacturer(s)"
          },
          {
            "code" : "ich_3.2.p.3.2",
            "display" : "m3.2.p.3.2 batch formula"
          },
          {
            "code" : "ich_3.2.p.3.3",
            "display" : "m3.2.p.3.3 description of manufacturing process and process controls"
          },
          {
            "code" : "ich_3.2.p.3.4",
            "display" : "m3.2.p.3.4 controls of critical steps and intermediates"
          },
          {
            "code" : "ich_3.2.p.3.5",
            "display" : "m3.2.p.3.5 process validation and/or evaluation"
          },
          {
            "code" : "ich_3.2.p.4",
            "display" : "m3.2.p.4 control of excipients"
          },
          {
            "code" : "ich_3.2.p.4.1",
            "display" : "m3.2.p.4.1 specifications"
          },
          {
            "code" : "ich_3.2.p.4.2",
            "display" : "m3.2.p.4.2 analytical procedures"
          },
          {
            "code" : "ich_3.2.p.4.3",
            "display" : "m3.2.p.4.3 validation of analytical procedures"
          },
          {
            "code" : "ich_3.2.p.4.4",
            "display" : "m3.2.p.4.4 justification of specifications"
          },
          {
            "code" : "ich_3.2.p.4.5",
            "display" : "m3.2.p.4.5 excipients of human or animal origin"
          },
          {
            "code" : "ich_3.2.p.4.6",
            "display" : "m3.2.p.4.6 novel excipients"
          },
          {
            "code" : "ich_3.2.p.5",
            "display" : "m3.2.p.5 control of drug product"
          },
          {
            "code" : "ich_3.2.p.5.1",
            "display" : "m3.2.p.5.1 specification(s)"
          },
          {
            "code" : "ich_3.2.p.5.2",
            "display" : "m3.2.p.5.2 analytical procedures"
          },
          {
            "code" : "ich_3.2.p.5.3",
            "display" : "m3.2.p.5.3 validation of analytical procedures"
          },
          {
            "code" : "ich_3.2.p.5.4",
            "display" : "m3.2.p.5.4 batch analyses"
          },
          {
            "code" : "ich_3.2.p.5.5",
            "display" : "m3.2.p.5.5 characterisation of impurities"
          },
          {
            "code" : "ich_3.2.p.5.6",
            "display" : "m3.2.p.5.6 justification of specifications"
          },
          {
            "code" : "ich_3.2.p.6",
            "display" : "m3.2.p.6 reference standards or materials"
          },
          {
            "code" : "ich_3.2.p.7",
            "display" : "m3.2.p.7 container closure system"
          },
          {
            "code" : "ich_3.2.p.8",
            "display" : "m3.2.p.8 stability"
          },
          {
            "code" : "ich_3.2.p.8.1",
            "display" : "m3.2.p.8.1 stability summary and conclusion"
          },
          {
            "code" : "ich_3.2.p.8.2",
            "display" : "m3.2.p.8.2 post-approval stability protocol and stability commitment"
          },
          {
            "code" : "ich_3.2.p.8.3",
            "display" : "m3.2.p.8.3 stability data"
          },
          {
            "code" : "ich_3.2.a",
            "display" : "m3.2.a appendices"
          },
          {
            "code" : "ich_3.2.a.1",
            "display" : "m3.2.a.1 facilities and equipment"
          },
          {
            "code" : "ich_3.2.a.2",
            "display" : "m3.2.a.2 adventitious agents safety evaluation"
          },
          {
            "code" : "ich_3.2.a.3",
            "display" : "m3.2.a.3 excipients"
          },
          {
            "code" : "ich_3.2.r",
            "display" : "m3.2 r regional information"
          },
          {
            "code" : "ich_3.3",
            "display" : "m3.3 literature references"
          }
        ]
      }
    ]
  }
}

XIG built as of ??metadata-date??. Found ??metadata-resources?? resources in ??metadata-packages?? packages.