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

## : eCTD sections Terminology - JSON Representation

Page standards status: Trial-use | Maturity Level: 2

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        "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>"
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      "version" : "2.0.0",
      "name" : "CmcCompSectionTypesVS",
      "title" : "eCTD sections Terminology",
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                "code" : "ich_3.2.s",
                "display" : "m3.2.s drug substance"
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              {
                "code" : "ich_3.2.s.1",
                "display" : "m3.2.s.1 general information"
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              {
                "code" : "ich_3.2.s.2",
                "display" : "m3.2.s.2 manufacture"
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              {
                "code" : "ich_3.2.s.2.1",
                "display" : "m3.2.s.2.1 manufacturer(s)"
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              {
                "code" : "ich_3.2.s.2.2",
                "display" : "m3.2.s.2.2 description of manufacturing process and process controls"
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              {
                "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"
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                "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"
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              {
                "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"
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              {
                "code" : "ich_3.2.s.4.5",
                "display" : "m3.2.s.4.5 justification of specification"
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                "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"
              },
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                "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"
              }
            ]
          }
        ]
      }
    }