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
2.0.0 - STU2
This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v2.0.0: STU2) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions
| Page standards status: Trial-use | Maturity Level: 2 |
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<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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<concept>
<code value="ich_3.2.s.1"/>
<display value="m3.2.s.1 general information"/>
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<concept>
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<concept>
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<display value="m3.2.s.2.6 manufacturing process development"/>
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<concept>
<code value="ich_3.2.s.3"/>
<display value="m3.2.s.3 characterisation"/>
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<concept>
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<display value="m3.2.s.3.2 impurities"/>
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<concept>
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<display value="m3.2.s.4 control of drug substance"/>
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<display value="m3.2.s.4.1 specification"/>
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<concept>
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<display value="m3.2.s.4.2 analytical procedures"/>
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<display value="m3.2.s.4.4 batch analyses"/>
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<display value="m3.2.s.4.5 justification of specification"/>
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<concept>
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<display value="m3.2.s.5 reference standards or materials"/>
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<concept>
<code value="ich_3.2.s.6"/>
<display value="m3.2.s.6 container closure system"/>
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<concept>
<code value="ich_3.2.s.7"/>
<display value="m3.2.s.7 stability"/>
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<concept>
<code value="ich_3.2.s.7.1"/>
<display value="m3.2.s.7.1 stability summary and conclusions"/>
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<concept>
<code value="ich_3.2.s.7.2"/>
<display
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<concept>
<code value="ich_3.2.s.7.3"/>
<display value="m3.2.s.7.3 stability data"/>
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<concept>
<code value="ich_3.2.p"/>
<display value="m3.2.p drug product"/>
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<concept>
<code value="ich_3.2.p.1"/>
<display
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<concept>
<code value="ich_3.2.p.2"/>
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<concept>
<code value="ich_3.2.p.2.5"/>
<display value="m3.2.p.2.5 microbiological attributes"/>
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<concept>
<code value="ich_3.2.p.2.6"/>
<display value="m3.2.p.2.6 compatibility"/>
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<display value="m3.2.p.3 manufacture"/>
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<display value="m3.2.p.3.2 batch formula"/>
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<display value="m3.2.p.3.5 process validation and/or evaluation"/>
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<concept>
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<display value="m3.2.p.4 control of excipients"/>
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<concept>
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<display value="m3.2.p.4.1 specifications"/>
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<concept>
<code value="ich_3.2.p.4.2"/>
<display value="m3.2.p.4.2 analytical procedures"/>
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<concept>
<code value="ich_3.2.p.4.3"/>
<display value="m3.2.p.4.3 validation of analytical procedures"/>
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<concept>
<code value="ich_3.2.p.4.4"/>
<display value="m3.2.p.4.4 justification of specifications"/>
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<concept>
<code value="ich_3.2.p.4.5"/>
<display value="m3.2.p.4.5 excipients of human or animal origin"/>
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<concept>
<code value="ich_3.2.p.4.6"/>
<display value="m3.2.p.4.6 novel excipients"/>
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<concept>
<code value="ich_3.2.p.5"/>
<display value="m3.2.p.5 control of drug product"/>
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<concept>
<code value="ich_3.2.p.5.1"/>
<display value="m3.2.p.5.1 specification(s)"/>
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<concept>
<code value="ich_3.2.p.5.2"/>
<display value="m3.2.p.5.2 analytical procedures"/>
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<concept>
<code value="ich_3.2.p.5.3"/>
<display value="m3.2.p.5.3 validation of analytical procedures"/>
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<display value="m3.2.p.5.4 batch analyses"/>
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<display value="m3.2.p.5.5 characterisation of impurities"/>
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<display value="m3.2.p.5.6 justification of specifications"/>
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<concept>
<code value="ich_3.2.p.6"/>
<display value="m3.2.p.6 reference standards or materials"/>
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<concept>
<code value="ich_3.2.p.7"/>
<display value="m3.2.p.7 container closure system"/>
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<concept>
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<display value="m3.2.p.8 stability"/>
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<concept>
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<display value="m3.2.p.8.1 stability summary and conclusion"/>
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<concept>
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<display
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<concept>
<code value="ich_3.2.p.8.3"/>
<display value="m3.2.p.8.3 stability data"/>
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<concept>
<code value="ich_3.2.a"/>
<display value="m3.2.a appendices"/>
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<concept>
<code value="ich_3.2.a.1"/>
<display value="m3.2.a.1 facilities and equipment"/>
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<concept>
<code value="ich_3.2.a.2"/>
<display value="m3.2.a.2 adventitious agents safety evaluation"/>
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<concept>
<code value="ich_3.2.a.3"/>
<display value="m3.2.a.3 excipients"/>
</concept>
<concept>
<code value="ich_3.2.r"/>
<display value="m3.2 r regional information"/>
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<concept>
<code value="ich_3.3"/>
<display value="m3.3 literature references"/>
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IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0 based on FHIR 5.0.0. Generated 2025-07-08
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