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

## : Test Category Terminology - XML Representation

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 pqcmc-test-category-terminology</b></p><a name="pqcmc-test-category-terminology"> </a><a name="hcpqcmc-test-category-terminology"> </a><p>This ValueSet requires the Code system Supplement <a href="CodeSystem-cmc-hierarchy-supplement.html">PQ-CMC-FDA NCIt Hierarchy Supplement</a>.</p><ul><li>Include these codes as defined in <a href="http://terminology.hl7.org/6.4.0/CodeSystem-v3-nciThesaurus.html"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C60819</td><td>Assay</td></tr><tr><td>C204845</td><td>Active Ingredient Content</td></tr><tr><td>C205001</td><td>Adventitious Agents (Safety)</td></tr><tr><td>C81183</td><td>Amino Acid Content</td></tr><tr><td>C205003</td><td>Bioburden</td></tr><tr><td>C205007</td><td>Counterion Content</td></tr><tr><td>C205015</td><td>Excipient</td></tr><tr><td>C205018</td><td>Host Cell DNA</td></tr><tr><td>C205020</td><td>In Vitro or In Vivo Test for Viral Contaminants</td></tr><tr><td>C205028</td><td>Percent Conjugate</td></tr><tr><td>C62352</td><td>Purity</td></tr><tr><td>C171277</td><td>Nucleic Acid Content</td></tr><tr><td>C205038</td><td>Solvate Content</td></tr><tr><td>C64858</td><td>Total Protein</td></tr><tr><td>C205006</td><td>Cell and Gene Therapy Product Characterization Assay</td></tr><tr><td>C134249</td><td>Container Closure Integrity</td></tr><tr><td>C134250</td><td>Uniformity</td></tr><tr><td>C205004</td><td>Blend Uniformity</td></tr><tr><td>C205019</td><td>IPC Content Uniformity</td></tr><tr><td>C134115</td><td>Uniformity of Dosage Unit</td></tr><tr><td>C205050</td><td>Uniformity in Containers</td></tr><tr><td>C133961</td><td>Deliverable Volume/Fill Volume</td></tr><tr><td>C205026</td><td>Organoleptic</td></tr><tr><td>C138990</td><td>Description/Appearance</td></tr><tr><td>C139027</td><td>Odor</td></tr><tr><td>C134262</td><td>Color of Solution</td></tr><tr><td>C134261</td><td>Clarity of Solution</td></tr><tr><td>C138993</td><td>Identification</td></tr><tr><td>C134252</td><td>Disintegration</td></tr><tr><td>C134253</td><td>Dissolution</td></tr><tr><td>C205012</td><td>Droplet Size</td></tr><tr><td>C193381</td><td>Foreign and Particulate Matter</td></tr><tr><td>C205024</td><td>Metal Detection</td></tr><tr><td>C134255</td><td>Loss on Drying</td></tr><tr><td>C134256</td><td>Microbial Limits</td></tr><tr><td>C205027</td><td>Osmolality/Osmolarity</td></tr><tr><td>C134257</td><td>Particle Size Distribution</td></tr><tr><td>C134260</td><td>Bulk Density</td></tr><tr><td>C134263</td><td>Conductivity</td></tr><tr><td>C133974</td><td>Crystallinity</td></tr><tr><td>C133975</td><td>Friability</td></tr><tr><td>C134264</td><td>Hardness</td></tr><tr><td>C63394</td><td>Melting Point</td></tr><tr><td>C103201</td><td>Optical Rotation</td></tr><tr><td>C205029</td><td>pH</td></tr><tr><td>C60821</td><td>Solubility</td></tr><tr><td>C64832</td><td>Specific Gravity</td></tr><tr><td>C25483</td><td>Material Properties/Measurements</td></tr><tr><td>C205022</td><td>Individual Weight</td></tr><tr><td>C205017</td><td>Group Weight</td></tr><tr><td>C205209</td><td>Average Weight</td></tr><tr><td>C205053</td><td>Weight Variation</td></tr><tr><td>C205021</td><td>Individual Fill Weight</td></tr><tr><td>C205016</td><td>Group Fill Weight</td></tr><tr><td>C205206</td><td>Average Fill Weight</td></tr><tr><td>C205045</td><td>Target Group Weight Gain %</td></tr><tr><td>C205036</td><td>Shell Weight</td></tr><tr><td>C205011</td><td>Orifice Location</td></tr><tr><td>C205010</td><td>Orifice Diameter</td></tr><tr><td>C205009</td><td>Orifice Depth</td></tr><tr><td>C205037</td><td>Drilled Side (Single or Double)</td></tr><tr><td>C205025</td><td>Number of Orifices</td></tr><tr><td>C205034</td><td>Ribbon Thickness</td></tr><tr><td>C205033</td><td>Ribbon Density</td></tr><tr><td>C205035</td><td>Seam Thickness</td></tr><tr><td>C205005</td><td>Lock Length</td></tr><tr><td>C205044</td><td>Tablet/Capsule Length</td></tr><tr><td>C205043</td><td>Tablet/Capsule Diameter</td></tr><tr><td>C205042</td><td>Tablet Thickness</td></tr><tr><td>C134266</td><td>Tap Density</td></tr><tr><td>C205049</td><td>Transdermal Properties</td></tr><tr><td>C133979</td><td>Viscosity/Rheological Properties</td></tr><tr><td>C134267</td><td>Plume Geometry</td></tr><tr><td>C134269</td><td>Polymorphism</td></tr><tr><td>C205030</td><td>Porosity</td></tr><tr><td>C134270</td><td>Potency</td></tr><tr><td>C133983</td><td>Pyrogenicity/Endotoxin</td></tr><tr><td>C134272</td><td>Reconstitution Time</td></tr><tr><td>C133985</td><td>Redispersibility</td></tr><tr><td>C205032</td><td>Refractive Index</td></tr><tr><td>C134276</td><td>Residue on Ignition</td></tr><tr><td>C134277</td><td>Spray Pattern</td></tr><tr><td>C134278</td><td>Sterility</td></tr><tr><td>C134113</td><td>Syringe Functionality</td></tr><tr><td>C134114</td><td>Total Organic Carbon</td></tr><tr><td>C200004</td><td>Cytotoxicity</td></tr><tr><td>C205023</td><td>Mechanical Integrity</td></tr><tr><td>C205041</td><td>Surface Area</td></tr><tr><td>C18951</td><td>Post-translational Modifications</td></tr><tr><td>C16643</td><td>Glycosylation</td></tr><tr><td>C205054</td><td>Thrombin Peptide Map</td></tr><tr><td>C205031</td><td>Sialylation</td></tr><tr><td>C205002</td><td>Amidation</td></tr><tr><td>C205008</td><td>Deamidation</td></tr><tr><td>C205000</td><td>Functional Assays</td></tr><tr><td>C205013</td><td>Elemental Analysis</td></tr><tr><td>C74723</td><td>Turbidity</td></tr><tr><td>C204971</td><td>Impurity</td></tr><tr><td>C205039</td><td>Specified Identified Impurity</td></tr><tr><td>C205040</td><td>Specified Unidentified Impurity</td></tr><tr><td>C205052</td><td>Unspecified Impurity</td></tr><tr><td>C205047</td><td>Total Impurities</td></tr><tr><td>C205048</td><td>Total Unknown Impurities</td></tr><tr><td>C205051</td><td>Identified Impurity under IT, Monitored as Unspecified</td></tr><tr><td>C205014</td><td>Elemental Impurity</td></tr><tr><td>C204890</td><td>Impurity Chemical</td></tr><tr><td>C134254</td><td>Impurities/Degradation Products/Related Substances</td></tr><tr><td>C134002</td><td>Residual Solvent</td></tr></table></li></ul></div>
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      <url
           value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology"/>
      <identifier>
        <system value="urn:ietf:rfc:3986"/>
        <value value="urn:oid:2.16.840.1.113883.4.642.40.36.48.28"/>
      </identifier>
      <version value="2.0.0"/>
      <name value="PqcmcTestCategoryTerminology"/>
      <title value="Test Category Terminology"/>
      <status value="active"/>
      <experimental value="false"/>
      <date value="2025-07-03T13:07:08+00:00"/>
      <publisher value="HL7 International / Biomedical Research and Regulation"/>
      <contact>
        <name value="HL7 International / Biomedical Research and Regulation"/>
        <telecom>
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      <description
                   value="Terminology used to qualify the information pertaining to test categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."/>
      <jurisdiction>
        <coding>
          <system value="urn:iso:std:iso:3166"/>
          <code value="US"/>
          <display value="United States of America"/>
        </coding>
      </jurisdiction>
      <compose>
        <include>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <concept>
            <code value="C60819"/>
            <display value="Assay"/>
          </concept>
          <concept>
            <code value="C204845"/>
            <display value="Active Ingredient Content"/>
          </concept>
          <concept>
            <code value="C205001"/>
            <display value="Adventitious Agents (Safety)"/>
          </concept>
          <concept>
            <code value="C81183"/>
            <display value="Amino Acid Content"/>
          </concept>
          <concept>
            <code value="C205003"/>
            <display value="Bioburden"/>
          </concept>
          <concept>
            <code value="C205007"/>
            <display value="Counterion Content"/>
          </concept>
          <concept>
            <code value="C205015"/>
            <display value="Excipient"/>
          </concept>
          <concept>
            <code value="C205018"/>
            <display value="Host Cell DNA"/>
          </concept>
          <concept>
            <code value="C205020"/>
            <display value="In Vitro or In Vivo Test for Viral Contaminants"/>
          </concept>
          <concept>
            <code value="C205028"/>
            <display value="Percent Conjugate"/>
          </concept>
          <concept>
            <code value="C62352"/>
            <display value="Purity"/>
          </concept>
          <concept>
            <code value="C171277"/>
            <display value="Nucleic Acid Content"/>
          </concept>
          <concept>
            <code value="C205038"/>
            <display value="Solvate Content"/>
          </concept>
          <concept>
            <code value="C64858"/>
            <display value="Total Protein"/>
          </concept>
          <concept>
            <code value="C205006"/>
            <display
                     value="Cell and Gene Therapy Product Characterization Assay"/>
          </concept>
          <concept>
            <code value="C134249"/>
            <display value="Container Closure Integrity"/>
          </concept>
          <concept>
            <code value="C134250"/>
            <display value="Uniformity"/>
          </concept>
          <concept>
            <code value="C205004"/>
            <display value="Blend Uniformity"/>
          </concept>
          <concept>
            <code value="C205019"/>
            <display value="IPC Content Uniformity"/>
          </concept>
          <concept>
            <code value="C134115"/>
            <display value="Uniformity of Dosage Unit"/>
          </concept>
          <concept>
            <code value="C205050"/>
            <display value="Uniformity in Containers"/>
          </concept>
          <concept>
            <code value="C133961"/>
            <display value="Deliverable Volume/Fill Volume"/>
          </concept>
          <concept>
            <code value="C205026"/>
            <display value="Organoleptic"/>
          </concept>
          <concept>
            <code value="C138990"/>
            <display value="Description/Appearance"/>
          </concept>
          <concept>
            <code value="C139027"/>
            <display value="Odor"/>
          </concept>
          <concept>
            <code value="C134262"/>
            <display value="Color of Solution"/>
          </concept>
          <concept>
            <code value="C134261"/>
            <display value="Clarity of Solution"/>
          </concept>
          <concept>
            <code value="C138993"/>
            <display value="Identification"/>
          </concept>
          <concept>
            <code value="C134252"/>
            <display value="Disintegration"/>
          </concept>
          <concept>
            <code value="C134253"/>
            <display value="Dissolution"/>
          </concept>
          <concept>
            <code value="C205012"/>
            <display value="Droplet Size"/>
          </concept>
          <concept>
            <code value="C193381"/>
            <display value="Foreign and Particulate Matter"/>
          </concept>
          <concept>
            <code value="C205024"/>
            <display value="Metal Detection"/>
          </concept>
          <concept>
            <code value="C134255"/>
            <display value="Loss on Drying"/>
          </concept>
          <concept>
            <code value="C134256"/>
            <display value="Microbial Limits"/>
          </concept>
          <concept>
            <code value="C205027"/>
            <display value="Osmolality/Osmolarity"/>
          </concept>
          <concept>
            <code value="C134257"/>
            <display value="Particle Size Distribution"/>
          </concept>
          <concept>
            <code value="C134260"/>
            <display value="Bulk Density"/>
          </concept>
          <concept>
            <code value="C134263"/>
            <display value="Conductivity"/>
          </concept>
          <concept>
            <code value="C133974"/>
            <display value="Crystallinity"/>
          </concept>
          <concept>
            <code value="C133975"/>
            <display value="Friability"/>
          </concept>
          <concept>
            <code value="C134264"/>
            <display value="Hardness"/>
          </concept>
          <concept>
            <code value="C63394"/>
            <display value="Melting Point"/>
          </concept>
          <concept>
            <code value="C103201"/>
            <display value="Optical Rotation"/>
          </concept>
          <concept>
            <code value="C205029"/>
            <display value="pH"/>
          </concept>
          <concept>
            <code value="C60821"/>
            <display value="Solubility"/>
          </concept>
          <concept>
            <code value="C64832"/>
            <display value="Specific Gravity"/>
          </concept>
          <concept>
            <code value="C25483"/>
            <display value="Material Properties/Measurements"/>
          </concept>
          <concept>
            <code value="C205022"/>
            <display value="Individual Weight"/>
          </concept>
          <concept>
            <code value="C205017"/>
            <display value="Group Weight"/>
          </concept>
          <concept>
            <code value="C205209"/>
            <display value="Average Weight"/>
          </concept>
          <concept>
            <code value="C205053"/>
            <display value="Weight Variation"/>
          </concept>
          <concept>
            <code value="C205021"/>
            <display value="Individual Fill Weight"/>
          </concept>
          <concept>
            <code value="C205016"/>
            <display value="Group Fill Weight"/>
          </concept>
          <concept>
            <code value="C205206"/>
            <display value="Average Fill Weight"/>
          </concept>
          <concept>
            <code value="C205045"/>
            <display value="Target Group Weight Gain %"/>
          </concept>
          <concept>
            <code value="C205036"/>
            <display value="Shell Weight"/>
          </concept>
          <concept>
            <code value="C205011"/>
            <display value="Orifice Location"/>
          </concept>
          <concept>
            <code value="C205010"/>
            <display value="Orifice Diameter"/>
          </concept>
          <concept>
            <code value="C205009"/>
            <display value="Orifice Depth"/>
          </concept>
          <concept>
            <code value="C205037"/>
            <display value="Drilled Side (Single or Double)"/>
          </concept>
          <concept>
            <code value="C205025"/>
            <display value="Number of Orifices"/>
          </concept>
          <concept>
            <code value="C205034"/>
            <display value="Ribbon Thickness"/>
          </concept>
          <concept>
            <code value="C205033"/>
            <display value="Ribbon Density"/>
          </concept>
          <concept>
            <code value="C205035"/>
            <display value="Seam Thickness"/>
          </concept>
          <concept>
            <code value="C205005"/>
            <display value="Lock Length"/>
          </concept>
          <concept>
            <code value="C205044"/>
            <display value="Tablet/Capsule Length"/>
          </concept>
          <concept>
            <code value="C205043"/>
            <display value="Tablet/Capsule Diameter"/>
          </concept>
          <concept>
            <code value="C205042"/>
            <display value="Tablet Thickness"/>
          </concept>
          <concept>
            <code value="C134266"/>
            <display value="Tap Density"/>
          </concept>
          <concept>
            <code value="C205049"/>
            <display value="Transdermal Properties"/>
          </concept>
          <concept>
            <code value="C133979"/>
            <display value="Viscosity/Rheological Properties"/>
          </concept>
          <concept>
            <code value="C134267"/>
            <display value="Plume Geometry"/>
          </concept>
          <concept>
            <code value="C134269"/>
            <display value="Polymorphism"/>
          </concept>
          <concept>
            <code value="C205030"/>
            <display value="Porosity"/>
          </concept>
          <concept>
            <code value="C134270"/>
            <display value="Potency"/>
          </concept>
          <concept>
            <code value="C133983"/>
            <display value="Pyrogenicity/Endotoxin"/>
          </concept>
          <concept>
            <code value="C134272"/>
            <display value="Reconstitution Time"/>
          </concept>
          <concept>
            <code value="C133985"/>
            <display value="Redispersibility"/>
          </concept>
          <concept>
            <code value="C205032"/>
            <display value="Refractive Index"/>
          </concept>
          <concept>
            <code value="C134276"/>
            <display value="Residue on Ignition"/>
          </concept>
          <concept>
            <code value="C134277"/>
            <display value="Spray Pattern"/>
          </concept>
          <concept>
            <code value="C134278"/>
            <display value="Sterility"/>
          </concept>
          <concept>
            <code value="C134113"/>
            <display value="Syringe Functionality"/>
          </concept>
          <concept>
            <code value="C134114"/>
            <display value="Total Organic Carbon"/>
          </concept>
          <concept>
            <code value="C200004"/>
            <display value="Cytotoxicity"/>
          </concept>
          <concept>
            <code value="C205023"/>
            <display value="Mechanical Integrity"/>
          </concept>
          <concept>
            <code value="C205041"/>
            <display value="Surface Area"/>
          </concept>
          <concept>
            <code value="C18951"/>
            <display value="Post-translational Modifications"/>
          </concept>
          <concept>
            <code value="C16643"/>
            <display value="Glycosylation"/>
          </concept>
          <concept>
            <code value="C205054"/>
            <display value="Thrombin Peptide Map"/>
          </concept>
          <concept>
            <code value="C205031"/>
            <display value="Sialylation"/>
          </concept>
          <concept>
            <code value="C205002"/>
            <display value="Amidation"/>
          </concept>
          <concept>
            <code value="C205008"/>
            <display value="Deamidation"/>
          </concept>
          <concept>
            <code value="C205000"/>
            <display value="Functional Assays"/>
          </concept>
          <concept>
            <code value="C205013"/>
            <display value="Elemental Analysis"/>
          </concept>
          <concept>
            <code value="C74723"/>
            <display value="Turbidity"/>
          </concept>
          <concept>
            <code value="C204971"/>
            <display value="Impurity"/>
          </concept>
          <concept>
            <code value="C205039"/>
            <display value="Specified Identified Impurity"/>
          </concept>
          <concept>
            <code value="C205040"/>
            <display value="Specified Unidentified Impurity"/>
          </concept>
          <concept>
            <code value="C205052"/>
            <display value="Unspecified Impurity"/>
          </concept>
          <concept>
            <code value="C205047"/>
            <display value="Total Impurities"/>
          </concept>
          <concept>
            <code value="C205048"/>
            <display value="Total Unknown Impurities"/>
          </concept>
          <concept>
            <code value="C205051"/>
            <display
                     value="Identified Impurity under IT, Monitored as Unspecified"/>
          </concept>
          <concept>
            <code value="C205014"/>
            <display value="Elemental Impurity"/>
          </concept>
          <concept>
            <code value="C204890"/>
            <display value="Impurity Chemical"/>
          </concept>
          <concept>
            <code value="C134254"/>
            <display value="Impurities/Degradation Products/Related Substances"/>
          </concept>
          <concept>
            <code value="C134002"/>
            <display value="Residual Solvent"/>
          </concept>
        </include>
      </compose>
    </ValueSet>