{
"description": "This code system contains temporary example codes for use in PQ.",
"_filename": "CodeSystem-cs-local-codes-drug-pq.json",
"package_name": "hl7.fhir.uv.pharm-quality",
"date": "2023-12-18T16:00:45+00:00",
"publisher": "HL7 International / Biomedical Research and Regulation",
"jurisdiction": [ {
"text": "World",
"coding": [ {
"code": "001",
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"display": "World"
} ]
} ],
"content": "complete",
"name": "CsLocalCodesDrugPQ",
"type": null,
"experimental": "false",
"resourceType": "CodeSystem",
"title": "CodeSystem - Example Local Codes - Drug",
"package_version": "1.0.0-ballot",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
} ],
"status": "active",
"id": "5b7f5aad-1b8f-43a8-83f6-16a9b051cbce",
"kind": null,
"url": "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"concept": [ {
"code": "ionic-strength",
"display": "Ionic Strength"
}, {
"code": "physicochemical",
"display": "Physicochemical properties"
}, {
"code": "SE-UHPLCHMW-15",
"display": "SE-UHPLC HMW - 15"
}, {
"code": "SE-UHPLCHMW-25",
"display": "SE-UHPLC HMW - 25"
}, {
"code": "SE-UHPLCMainPeak-15",
"display": "SE-UHPLC Main Peak - 15"
}, {
"code": "SE-UHPLCMainPeak-25",
"display": "SE-UHPLC Main Peak - 25"
}, {
"code": "SIZE",
"display": "Particle Size"
}, {
"code": "SOL",
"display": "Residual solvents"
}, {
"code": "SOLV",
"display": "Solvent"
}, {
"code": "SSE",
"display": "Statistically significant effects"
}, {
"code": "TEMP",
"display": "Temperature"
}, {
"code": "UCL",
"display": "Upper one-sided 95% confidence limit of Max Difference"
}, {
"code": "uniformity-dosage",
"display": "uniformity of dosage units (by weight)"
}, {
"code": "WWWH",
"display": "Water Content Homogeneity"
}, {
"code": "SAMP",
"display": "Number of Samples"
}, {
"code": "DGP",
"display": "Degradation Products"
}, {
"code": "DGP-s",
"display": "Drug Substance Related Organic impurities"
}, {
"code": "IMP",
"display": "Impurity"
}, {
"code": "Impurities",
"display": "Impurities"
}, {
"code": "WWW",
"display": "Water Content"
}, {
"code": "Microbiological Quality",
"display": "Microbiological Quality"
}, {
"code": "ASSAY",
"display": "Assay"
}, {
"code": "CEX-HPLCAcidicPeak",
"display": "CEX-HPLC Acidic Peak"
}, {
"code": "CEX-HPLCMainPeak",
"display": "CEX-HPLC Main Peak"
}, {
"code": "PART",
"display": "Particle size distribution"
}, {
"code": "ASSH",
"display": "Assay Content Homogeneity"
}, {
"code": "DESC",
"display": "Description"
}, {
"code": "Dissolution",
"display": "Dissolution"
}, {
"code": "Dissolution Quantity",
"display": "Dissolution Quantity"
}, {
"code": "ELE",
"display": "Elemental impurities"
}, {
"code": "enantiomeric-purity",
"display": "Enantiomeric purity"
}, {
"code": "IDT",
"display": "Identification"
}, {
"code": "MUT",
"display": "Mutagenic impurities"
}, {
"code": "NMR",
"display": "NMR"
}, {
"code": "NMR-C",
"display": "NMR-C"
}, {
"code": "NMR-H",
"display": "NMR-H"
}, {
"code": "CEX-HPLCAcidicPeak-15",
"display": "CEX-HPLC Acidic Peak - 15"
}, {
"code": "CEX-HPLCAcidicPeak-25",
"display": "CEX-HPLC Acidic Peak - 25"
}, {
"code": "CEX-HPLCMainPeak-15",
"display": "CEX-HPLC Main Peak - 15"
}, {
"code": "CEX-HPLCMainPeak-25",
"display": "CEX-HPLC Main Peak - 25"
}, {
"code": "Homogeneity",
"display": "Homogeneity demonstrated"
}, {
"code": "LCL",
"display": "Lower one-sided 95% confidence limit of Max Difference"
}, {
"code": "LOC",
"display": "Number of Locations"
}, {
"code": "PARTS",
"display": "Particle size"
}, {
"code": "POS",
"display": "Structure Position"
}, {
"code": "particle-size-distribution",
"display": "Particle size distribution"
}, {
"code": "Lyophilization Water Homogeneity",
"display": "Lyophilization Water Homogeneity"
}, {
"code": "Lyophilization Assay Homogeneity",
"display": "Lyophilization Assay Homogeneity"
}, {
"code": "Particle Size RSD",
"display": "Particle Size RSD"
}, {
"code": "Obscuration",
"display": "Obscuration"
}, {
"code": "Refractive index",
"display": "Refractive index"
}, {
"code": "ElementalAnalysisCarbon",
"display": "Elemental Analysis Carbon (%)"
}, {
"code": "IonAnalysisCarbonMass",
"display": "Ion Analysis Carbon - Mass"
}, {
"code": "IonAnalysisCarbonMassAccuracy",
"display": "Ion Analysis Carbon - Mass Accuracy"
}, {
"code": "IonAnalysisCarbon",
"display": "Ion Analysis Carbon (%)"
}, {
"code": "ElementalAnalysisHydrogen",
"display": "Elemental Analysis Hydrogen (%)"
}, {
"code": "IonAnalysisHydrogenMass",
"display": "Ion Analysis Hydrogen - Mass"
}, {
"code": "IonAnalysisHydrogenMassAccuracy",
"display": "Ion Analysis Hydrogen - Mass Accuracy"
}, {
"code": "IonAnalysisHydrogen",
"display": "Ion Analysis Hydrogen (%)"
}, {
"code": "ElementalAnalysisNitrogen",
"display": "Elemental Analysis Nitrogen (%)"
}, {
"code": "IonAnalysisNitrogen",
"display": "Ion Analysis Nitrogen (%)"
}, {
"code": "IonAnalysisNitrogenMass",
"display": "Ion Analysis Nitrogen - Mass"
}, {
"code": "IonAnalysisNitrogenMassAccuracy",
"display": "Ion Analysis Nitrogen - Mass Accuracy"
}, {
"code": "ElementalAnalysisFlourine",
"display": "Elemental Analysis Flourine (%)"
}, {
"code": "IonAnalysisFlourine",
"display": "Ion Analysis Flourine (%)"
}, {
"code": "IonAnalysisFlourineMass",
"display": "Ion Analysis Flourine - Mass"
}, {
"code": "IonAnalysisFlourineMassAccuracy",
"display": "Ion Analysis Flourine - Mass Accuracy"
}, {
"code": "Chemical Structure",
"display": "Chemical Structure"
}, {
"code": "Diffractogram",
"display": "Diffractogram"
}, {
"code": "MolecularStructure",
"display": "Molecular Structure"
}, {
"code": "Absorption",
"display": "Absorption"
}, {
"code": "X-Ray Powder Diffractogram",
"display": "X-Ray Powder Diffractogram"
}, {
"code": "pH (post-dilution bulk solution)",
"display": "pH (post-dilution bulk solution)"
}, {
"code": "Appearance (Product Container, visual)",
"display": "Appearance (Product Container, visual)"
}, {
"code": "Appearance (Lyophilized, Visual)",
"display": "Appearance (Lyophilized, Visual)"
}, {
"code": "Appearance (Reconstituted, Visual)",
"display": "Appearance (Reconstituted, Visual)"
}, {
"code": "Appearance",
"display": "Appearance"
}, {
"code": "pH (reconstituted)",
"display": "pH (reconstituted)"
}, {
"code": "TAMC",
"display": "TAMC"
}, {
"code": "Fill Weight Average",
"display": "Fill Weight Average"
}, {
"code": "Fill Weight Target (g)",
"display": "Fill Weight Target (g)"
}, {
"code": "Actual Avg. Weight from Target",
"display": "Actual Avg. Weight from Target"
}, {
"code": "Hold Time (filtration To filling)",
"display": "Hold Time (filtration To filling)"
}, {
"code": "Hold Time (start filling to end filling)",
"display": "Hold Time (start filling to end filling)"
}, {
"code": "Filter Integrity Test",
"display": "Filter Integrity Test"
}, {
"code": "Lyophilizer Number",
"display": "Lyophilizer Number"
}, {
"code": "pH (adjustment of pre-clarification bulk solution)",
"display": "pH (adjustment of pre-clarification bulk solution)"
}, {
"code": "Assay (pre-clarification filtration) (mg/mL)",
"display": "Assay (pre-clarification filtration) (mg/mL)"
}, {
"code": "Assay (Post dilution bulk solution) (mg/mL)",
"display": "Assay (Post dilution bulk solution) (mg/mL)"
}, {
"code": "Test Date",
"display": "Test Date"
}, {
"code": "Identification (NMR)",
"display": "Identification (NMR)"
}, {
"code": "Identification (FT-IR)",
"display": "Identification (FT-IR)"
}, {
"code": "VisualInspection",
"display": "VisualInspection"
}, {
"code": "InfraredSpectroscopy",
"display": "InfraredSpectroscopy"
}, {
"code": "SupplierCertificateofAnalysis",
"display": "SupplierCertificateofAnalysis"
}, {
"code": "Elemental",
"display": "Elemental"
}, {
"code": "Uniformity of Dosage Units, Weight Variation",
"display": "Uniformity of Dosage Units, Weight Variation"
}, {
"code": "Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)",
"display": "Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)"
}, {
"code": "Yield (%)",
"display": "Yield (%)"
}, {
"code": "ResidualWaterContent",
"display": "Residual Water Content (w/w%)"
}, {
"code": "Reaction conversion: Residual Starting Material 1 by HPLC",
"display": "Reaction conversion: Residual Starting Material 1 by HPLC"
}, {
"code": "Bacterial Endotoxins (EU/mL)",
"display": "Bacterial Endotoxins (EU/mL)"
}, {
"code": "Bioburden - Beginning",
"display": "Bioburden - Beginning"
}, {
"code": "Bioburden - End",
"display": "Bioburden - End"
}, {
"code": "Bioburden (CFU/ 100 mL)",
"display": "Bioburden (CFU/ 100 mL)"
}, {
"code": "Buffer vessel mixing speed (rpm)",
"display": "Buffer vessel mixing speed (rpm)"
}, {
"code": "Buffer vessel mixing time (min)",
"display": "Buffer vessel mixing time (min)"
}, {
"code": "CONC",
"display": "Conclusion"
}, {
"code": "Conductivity (μS/cm)",
"display": "Conductivity (μS/cm)"
}, {
"code": "Fill Weight",
"display": "Fill Weight"
}, {
"code": "Fill Weight - Maximum",
"display": "Fill Weight - Maximum"
}, {
"code": "Fill Weight - Mean",
"display": "Fill Weight - Mean"
}, {
"code": "Fill Weight - Minimum",
"display": "Fill Weight - Minimum"
}, {
"code": "FiltrationPressure (psig)",
"display": "FiltrationPressure (psig)"
}, {
"code": "Formulation vessel mixing speed (rpm)",
"display": "Formulation vessel mixing speed (rpm)"
}, {
"code": "Formulation vessel mixing time (min)",
"display": "Formulation vessel mixing time (min)"
}, {
"code": "Growth Promotion - Beginning",
"display": "Growth Promotion - Beginning"
}, {
"code": "Growth Promotion - End",
"display": "Growth Promotion - End"
}, {
"code": "GrowthPromotion",
"display": "Growth Promotion"
}, {
"code": "Hold Time",
"display": "Hold Time"
}, {
"code": "LyophilizationHomogeneneity",
"display": "Lyophilization Homogeneneity"
}, {
"code": "Media Challenge Hold Times",
"display": "Media Challenge Hold Times"
}, {
"code": "MediaChallengeRun",
"display": "Media Challenge Run"
}, {
"code": "Osmolality",
"display": "Osmolality"
}, {
"code": "OVERALLSAMP",
"display": "Number of Samples"
}, {
"code": "particle-size",
"display": "Particle Size"
}, {
"code": "pH",
"display": "pH"
}, {
"code": "Polysorbate 80 (% w/v)",
"display": "Polysorbate 80 (% w/v)"
}, {
"code": "Polysorbate 80 concentration - Beginning - Max",
"display": "Polysorbate 80 concentration - Beginning - Max"
}, {
"code": "Polysorbate 80 concentration - Beginning - Min",
"display": "Polysorbate 80 concentration - Beginning - Min"
}, {
"code": "Polysorbate 80 concentration - End - Max",
"display": "Polysorbate 80 concentration - End - Max"
}, {
"code": "Polysorbate 80 concentration - End - Min",
"display": "Polysorbate 80 concentration - End - Min"
}, {
"code": "Polysorbate 80 concentration - Middle - Max",
"display": "Polysorbate 80 concentration - Middle - Max"
}, {
"code": "Polysorbate 80 concentration - Middle - Min",
"display": "Polysorbate 80 concentration - Middle - Min"
}, {
"code": "Polysorbate 80 concentration (% w/v)",
"display": "Polysorbate 80 concentration (% w/v)"
}, {
"code": "Post-filtration Filter Integrity (psig)",
"display": "Post-filtration Filter Integrity (psig)"
}, {
"code": "Pre-filtration Bioburden (CFU/ 100 mL)",
"display": "Pre-filtration Bioburden (CFU/ 100 mL)"
}, {
"code": "Protein Concentration (mg/mL)",
"display": "Protein Concentration (mg/mL)"
}, {
"code": "Protein Concentration - Beginning - End - Higher",
"display": "Protein Concentration - Beginning - End - Higher"
}, {
"code": "Protein Concentration - Beginning - End - Lower",
"display": "Protein Concentration - Beginning - End - Lower"
}, {
"code": "Protein Concentration - Beginning - End - Mean",
"display": "Protein Concentration - Beginning - End - Mean"
}, {
"code": "Protein Concentration - Beginning - Max",
"display": "Protein Concentration - Beginning - Max"
}, {
"code": "Protein Concentration - Beginning - Middle - Higher",
"display": "Protein Concentration - Beginning - Middle - Higher"
}, {
"code": "Protein Concentration - Beginning - Middle - Lower",
"display": "Protein Concentration - Beginning - Middle - Lower"
}, {
"code": "Protein Concentration - Beginning - Middle - Mean",
"display": "Protein Concentration - Beginning - Middle - Mean"
}, {
"code": "Protein Concentration - Beginning - Min",
"display": "Protein Concentration - Beginning - Min"
}, {
"code": "Protein Concentration - Conclusion",
"display": "Protein Concentration - Conclusion"
}, {
"code": "Protein Concentration - End - Max",
"display": "Protein Concentration - End - Max"
}, {
"code": "Protein Concentration - End - Min",
"display": "Protein Concentration - End - Min"
}, {
"code": "Protein Concentration - Middle - End - Higher",
"display": "Protein Concentration - Middle - End - Higher"
}, {
"code": "Protein Concentration - Middle - End - Lower",
"display": "Protein Concentration - Middle - End - Lower"
}, {
"code": "Protein Concentration - Middle - End - Mean",
"display": "Protein Concentration - Middle - End - Mean"
}, {
"code": "Protein Concentration - Middle - Max",
"display": "Protein Concentration - Middle - Max"
}, {
"code": "Protein Concentration - Middle - Min",
"display": "Protein Concentration - Middle - Min"
}, {
"code": "Protein Concentration Statistics",
"display": "Protein Concentration Statistics"
}, {
"code": "Residual Moisture - Max",
"display": "Residual Moisture - Max"
}, {
"code": "Residual Moisture - Min",
"display": "Residual Moisture - Min"
}, {
"code": "Residual Moisture",
"display": "Residual Moisture"
}, {
"code": "SE-UHPLC Main Peak - Beginning",
"display": "SE-UHPLC Main Peak - Beginning"
}, {
"code": "SE-UHPLC HMW - Conclusion",
"display": "SE-UHPLC HMW - Conclusion"
}, {
"code": "SE-UHPLC Main Peak - Conclusion",
"display": "SE-UHPLC Main Peak - Conclusion"
}, {
"code": "SE-UHPLC Main Peak - End",
"display": "SE-UHPLC Main Peak - End"
}, {
"code": "SE-UHPLCHMW - Beginning",
"display": "SE-UHPLC HMW - Beginning"
}, {
"code": "SE-UHPLCHMW - End",
"display": "SE-UHPLC HMW - End"
}, {
"code": "SE-UHPLCHMWPeak - Conclusion",
"display": "SE-UHPLC HMW Peak - Conclusion"
}, {
"code": "SE-UHPLCHMW",
"display": "SE-UHPLC HMW"
}, {
"code": "SE-UHPLCMainPeak - Conclusion",
"display": "SE-UHPLC Main Peak - Conclusion"
}, {
"code": "SE-UHPLCMainPeak",
"display": "SE-UHPLC Main Peak"
}, {
"code": "test-success",
"display": "Test Success"
}, {
"code": "Thaw Time",
"display": "Thaw Time"
}, {
"code": "Thawing Temp",
"display": "Thawing Temp"
}, {
"code": "WaterContent",
"display": "Water content"
}, {
"code": "AssignedPurity",
"display": "Assigned Purity"
} ],
"caseSensitive": true,
"version": "1.0.0-ballot",
"contact": [ {
"name": "HL7 International - Biomedical Research and Regulation",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
} ]
} ]
}