Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
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-ballot 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
| Active as of 2024-12-04 |
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"div" : "<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><a name=\"pqcmc-test-category-terminology-en-US\"> </a><ul><li>Include these codes as defined in <a href=\"http://terminology.hl7.org/6.1.0/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" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology",
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],
"version" : "2.0.0-ballot",
"name" : "PqcmcTestCategoryTerminology",
"title" : "Test Category Terminology",
"status" : "active",
"experimental" : false,
"date" : "2024-12-04T20:50:29+00:00",
"publisher" : "HL7 International / Biomedical Research and Regulation",
"contact" : [
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],
"description" : "Terminology used to qualify the information pertaining to test categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.",
"jurisdiction" : [
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"coding" : [
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"compose" : {
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"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"concept" : [
{
"code" : "C60819",
"display" : "Assay"
},
{
"code" : "C204845",
"display" : "Active Ingredient Content"
},
{
"code" : "C205001",
"display" : "Adventitious Agents (Safety)"
},
{
"code" : "C81183",
"display" : "Amino Acid Content"
},
{
"code" : "C205003",
"display" : "Bioburden"
},
{
"code" : "C205007",
"display" : "Counterion Content"
},
{
"code" : "C205015",
"display" : "Excipient"
},
{
"code" : "C205018",
"display" : "Host Cell DNA"
},
{
"code" : "C205020",
"display" : "In Vitro or In Vivo Test for Viral Contaminants"
},
{
"code" : "C205028",
"display" : "Percent Conjugate"
},
{
"code" : "C62352",
"display" : "Purity"
},
{
"code" : "C171277",
"display" : "Nucleic Acid Content"
},
{
"code" : "C205038",
"display" : "Solvate Content"
},
{
"code" : "C64858",
"display" : "Total Protein"
},
{
"code" : "C205006",
"display" : "Cell and Gene Therapy Product Characterization Assay"
},
{
"code" : "C134249",
"display" : "Container Closure Integrity"
},
{
"code" : "C134250",
"display" : "Uniformity"
},
{
"code" : "C205004",
"display" : "Blend Uniformity"
},
{
"code" : "C205019",
"display" : "IPC Content Uniformity"
},
{
"code" : "C134115",
"display" : "Uniformity of Dosage Unit"
},
{
"code" : "C205050",
"display" : "Uniformity in Containers"
},
{
"code" : "C133961",
"display" : "Deliverable Volume/Fill Volume"
},
{
"code" : "C205026",
"display" : "Organoleptic"
},
{
"code" : "C138990",
"display" : "Description/Appearance"
},
{
"code" : "C139027",
"display" : "Odor"
},
{
"code" : "C134262",
"display" : "Color of Solution"
},
{
"code" : "C134261",
"display" : "Clarity of Solution"
},
{
"code" : "C138993",
"display" : "Identification"
},
{
"code" : "C134252",
"display" : "Disintegration"
},
{
"code" : "C134253",
"display" : "Dissolution"
},
{
"code" : "C205012",
"display" : "Droplet Size"
},
{
"code" : "C193381",
"display" : "Foreign and Particulate Matter"
},
{
"code" : "C205024",
"display" : "Metal Detection"
},
{
"code" : "C134255",
"display" : "Loss on Drying"
},
{
"code" : "C134256",
"display" : "Microbial Limits"
},
{
"code" : "C205027",
"display" : "Osmolality/Osmolarity"
},
{
"code" : "C134257",
"display" : "Particle Size Distribution"
},
{
"code" : "C134260",
"display" : "Bulk Density"
},
{
"code" : "C134263",
"display" : "Conductivity"
},
{
"code" : "C133974",
"display" : "Crystallinity"
},
{
"code" : "C133975",
"display" : "Friability"
},
{
"code" : "C134264",
"display" : "Hardness"
},
{
"code" : "C63394",
"display" : "Melting Point"
},
{
"code" : "C103201",
"display" : "Optical Rotation"
},
{
"code" : "C205029",
"display" : "pH"
},
{
"code" : "C60821",
"display" : "Solubility"
},
{
"code" : "C64832",
"display" : "Specific Gravity"
},
{
"code" : "C25483",
"display" : "Material Properties/Measurements"
},
{
"code" : "C205022",
"display" : "Individual Weight"
},
{
"code" : "C205017",
"display" : "Group Weight"
},
{
"code" : "C205209",
"display" : "Average Weight"
},
{
"code" : "C205053",
"display" : "Weight Variation"
},
{
"code" : "C205021",
"display" : "Individual Fill Weight"
},
{
"code" : "C205016",
"display" : "Group Fill Weight"
},
{
"code" : "C205206",
"display" : "Average Fill Weight"
},
{
"code" : "C205045",
"display" : "Target Group Weight Gain %"
},
{
"code" : "C205036",
"display" : "Shell Weight"
},
{
"code" : "C205011",
"display" : "Orifice Location"
},
{
"code" : "C205010",
"display" : "Orifice Diameter"
},
{
"code" : "C205009",
"display" : "Orifice Depth"
},
{
"code" : "C205037",
"display" : "Drilled Side (Single or Double)"
},
{
"code" : "C205025",
"display" : "Number of Orifices"
},
{
"code" : "C205034",
"display" : "Ribbon Thickness"
},
{
"code" : "C205033",
"display" : "Ribbon Density"
},
{
"code" : "C205035",
"display" : "Seam Thickness"
},
{
"code" : "C205005",
"display" : "Lock Length"
},
{
"code" : "C205044",
"display" : "Tablet/Capsule Length"
},
{
"code" : "C205043",
"display" : "Tablet/Capsule Diameter"
},
{
"code" : "C205042",
"display" : "Tablet Thickness"
},
{
"code" : "C134266",
"display" : "Tap Density"
},
{
"code" : "C205049",
"display" : "Transdermal Properties"
},
{
"code" : "C133979",
"display" : "Viscosity/Rheological Properties"
},
{
"code" : "C134267",
"display" : "Plume Geometry"
},
{
"code" : "C134269",
"display" : "Polymorphism"
},
{
"code" : "C205030",
"display" : "Porosity"
},
{
"code" : "C134270",
"display" : "Potency"
},
{
"code" : "C133983",
"display" : "Pyrogenicity/Endotoxin"
},
{
"code" : "C134272",
"display" : "Reconstitution Time"
},
{
"code" : "C133985",
"display" : "Redispersibility"
},
{
"code" : "C205032",
"display" : "Refractive Index"
},
{
"code" : "C134276",
"display" : "Residue on Ignition"
},
{
"code" : "C134277",
"display" : "Spray Pattern"
},
{
"code" : "C134278",
"display" : "Sterility"
},
{
"code" : "C134113",
"display" : "Syringe Functionality"
},
{
"code" : "C134114",
"display" : "Total Organic Carbon"
},
{
"code" : "C200004",
"display" : "Cytotoxicity"
},
{
"code" : "C205023",
"display" : "Mechanical Integrity"
},
{
"code" : "C205041",
"display" : "Surface Area"
},
{
"code" : "C18951",
"display" : "Post-translational Modifications"
},
{
"code" : "C16643",
"display" : "Glycosylation"
},
{
"code" : "C205054",
"display" : "Thrombin Peptide Map"
},
{
"code" : "C205031",
"display" : "Sialylation"
},
{
"code" : "C205002",
"display" : "Amidation"
},
{
"code" : "C205008",
"display" : "Deamidation"
},
{
"code" : "C205000",
"display" : "Functional Assays"
},
{
"code" : "C205013",
"display" : "Elemental Analysis"
},
{
"code" : "C74723",
"display" : "Turbidity"
},
{
"code" : "C204971",
"display" : "Impurity"
},
{
"code" : "C205039",
"display" : "Specified Identified Impurity"
},
{
"code" : "C205040",
"display" : "Specified Unidentified Impurity"
},
{
"code" : "C205052",
"display" : "Unspecified Impurity"
},
{
"code" : "C205047",
"display" : "Total Impurities"
},
{
"code" : "C205048",
"display" : "Total Unknown Impurities"
},
{
"code" : "C205051",
"display" : "Identified Impurity under IT, Monitored as Unspecified"
},
{
"code" : "C205014",
"display" : "Elemental Impurity"
},
{
"code" : "C204890",
"display" : "Impurity Chemical"
},
{
"code" : "C134254",
"display" : "Impurities/Degradation Products/Related Substances"
},
{
"code" : "C134002",
"display" : "Residual Solvent"
}
]
}
]
}
}
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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