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Resource ValueSet/FHIR Server from package hl7.fhir.us.pq-cmc-fda#current (62 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-pqcmc-test-category-terminology.html
Url http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology
Version 2.0.0-ballot
Status active
Date 2024-12-12T01:58:44+00:00
Name PqcmcTestCategoryTerminology
Title Test Category Terminology
Experimental False
Realm us
Authority hl7
Description Terminology used to qualify the information pertaining to test categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Resources that use this resource

StructureDefinition
pqcmc-quality-specification Quality Specification

Resources that this resource uses

CodeSystem
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl NCI Thesaurus


Narrative

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

Generated Narrative: ValueSet pqcmc-test-category-terminology

  • Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    CodeDisplay
    C60819Assay
    C204845Active Ingredient Content
    C205001Adventitious Agents (Safety)
    C81183Amino Acid Content
    C205003Bioburden
    C205007Counterion Content
    C205015Excipient
    C205018Host Cell DNA
    C205020In Vitro or In Vivo Test for Viral Contaminants
    C205028Percent Conjugate
    C62352Purity
    C171277Nucleic Acid Content
    C205038Solvate Content
    C64858Total Protein
    C205006Cell and Gene Therapy Product Characterization Assay
    C134249Container Closure Integrity
    C134250Uniformity
    C205004Blend Uniformity
    C205019IPC Content Uniformity
    C134115Uniformity of Dosage Unit
    C205050Uniformity in Containers
    C133961Deliverable Volume/Fill Volume
    C205026Organoleptic
    C138990Description/Appearance
    C139027Odor
    C134262Color of Solution
    C134261Clarity of Solution
    C138993Identification
    C134252Disintegration
    C134253Dissolution
    C205012Droplet Size
    C193381Foreign and Particulate Matter
    C205024Metal Detection
    C134255Loss on Drying
    C134256Microbial Limits
    C205027Osmolality/Osmolarity
    C134257Particle Size Distribution
    C134260Bulk Density
    C134263Conductivity
    C133974Crystallinity
    C133975Friability
    C134264Hardness
    C63394Melting Point
    C103201Optical Rotation
    C205029pH
    C60821Solubility
    C64832Specific Gravity
    C25483Material Properties/Measurements
    C205022Individual Weight
    C205017Group Weight
    C205209Average Weight
    C205053Weight Variation
    C205021Individual Fill Weight
    C205016Group Fill Weight
    C205206Average Fill Weight
    C205045Target Group Weight Gain %
    C205036Shell Weight
    C205011Orifice Location
    C205010Orifice Diameter
    C205009Orifice Depth
    C205037Drilled Side (Single or Double)
    C205025Number of Orifices
    C205034Ribbon Thickness
    C205033Ribbon Density
    C205035Seam Thickness
    C205005Lock Length
    C205044Tablet/Capsule Length
    C205043Tablet/Capsule Diameter
    C205042Tablet Thickness
    C134266Tap Density
    C205049Transdermal Properties
    C133979Viscosity/Rheological Properties
    C134267Plume Geometry
    C134269Polymorphism
    C205030Porosity
    C134270Potency
    C133983Pyrogenicity/Endotoxin
    C134272Reconstitution Time
    C133985Redispersibility
    C205032Refractive Index
    C134276Residue on Ignition
    C134277Spray Pattern
    C134278Sterility
    C134113Syringe Functionality
    C134114Total Organic Carbon
    C200004Cytotoxicity
    C205023Mechanical Integrity
    C205041Surface Area
    C18951Post-translational Modifications
    C16643Glycosylation
    C205054Thrombin Peptide Map
    C205031Sialylation
    C205002Amidation
    C205008Deamidation
    C205000Functional Assays
    C205013Elemental Analysis
    C74723Turbidity
    C204971Impurity
    C205039Specified Identified Impurity
    C205040Specified Unidentified Impurity
    C205052Unspecified Impurity
    C205047Total Impurities
    C205048Total Unknown Impurities
    C205051Identified Impurity under IT, Monitored as Unspecified
    C205014Elemental Impurity
    C204890Impurity Chemical
    C134254Impurities/Degradation Products/Related Substances
    C134002Residual Solvent

Source

{
  "resourceType" : "ValueSet",
  "id" : "pqcmc-test-category-terminology",
  "text" : {
    "status" : "generated",
    "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>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/valueset-supplement",
      "valueCanonical" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-hierarchy-supplement"
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode" : "brr"
    }
  ],
  "url" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology",
  "identifier" : [
    {
      "system" : "urn:ietf:rfc:3986",
      "value" : "urn:oid:2.16.840.1.113883.4.642.40.36.48.28"
    }
  ],
  "version" : "2.0.0-ballot",
  "name" : "PqcmcTestCategoryTerminology",
  "title" : "Test Category Terminology",
  "status" : "active",
  "experimental" : false,
  "date" : "2024-12-12T01:58:44+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" : "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" : "urn:iso:std:iso:3166",
          "code" : "US",
          "display" : "United States of America"
        }
      ]
    }
  ],
  "compose" : {
    "include" : [
      {
        "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"
          }
        ]
      }
    ]
  }
}

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