Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
| Active as of 2023-12-18 |
{
"resourceType" : "CodeSystem",
"id" : "cs-local-codes-drug-pq",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This case-sensitive code system <code>http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq</code> defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td style=\"white-space:nowrap\">ionic-strength<a name=\"cs-local-codes-drug-pq-ionic-strength\"> </a></td><td>Ionic Strength</td></tr><tr><td style=\"white-space:nowrap\">physicochemical<a name=\"cs-local-codes-drug-pq-physicochemical\"> </a></td><td>Physicochemical properties</td></tr><tr><td style=\"white-space:nowrap\">SE-UHPLCHMW-15<a name=\"cs-local-codes-drug-pq-SE-UHPLCHMW-15\"> </a></td><td>SE-UHPLC HMW - 15</td></tr><tr><td style=\"white-space:nowrap\">SE-UHPLCHMW-25<a name=\"cs-local-codes-drug-pq-SE-UHPLCHMW-25\"> </a></td><td>SE-UHPLC HMW - 25</td></tr><tr><td style=\"white-space:nowrap\">SE-UHPLCMainPeak-15<a name=\"cs-local-codes-drug-pq-SE-UHPLCMainPeak-15\"> </a></td><td>SE-UHPLC Main Peak - 15</td></tr><tr><td style=\"white-space:nowrap\">SE-UHPLCMainPeak-25<a name=\"cs-local-codes-drug-pq-SE-UHPLCMainPeak-25\"> </a></td><td>SE-UHPLC Main Peak - 25</td></tr><tr><td style=\"white-space:nowrap\">SIZE<a name=\"cs-local-codes-drug-pq-SIZE\"> </a></td><td>Particle Size</td></tr><tr><td style=\"white-space:nowrap\">SOL<a name=\"cs-local-codes-drug-pq-SOL\"> </a></td><td>Residual solvents</td></tr><tr><td style=\"white-space:nowrap\">SOLV<a name=\"cs-local-codes-drug-pq-SOLV\"> </a></td><td>Solvent</td></tr><tr><td style=\"white-space:nowrap\">SSE<a name=\"cs-local-codes-drug-pq-SSE\"> </a></td><td>Statistically significant effects</td></tr><tr><td style=\"white-space:nowrap\">TEMP<a name=\"cs-local-codes-drug-pq-TEMP\"> </a></td><td>Temperature</td></tr><tr><td style=\"white-space:nowrap\">UCL<a name=\"cs-local-codes-drug-pq-UCL\"> </a></td><td>Upper one-sided 95% confidence limit of Max Difference</td></tr><tr><td style=\"white-space:nowrap\">uniformity-dosage<a name=\"cs-local-codes-drug-pq-uniformity-dosage\"> </a></td><td>uniformity of dosage units (by weight)</td></tr><tr><td style=\"white-space:nowrap\">WWWH<a name=\"cs-local-codes-drug-pq-WWWH\"> </a></td><td>Water Content Homogeneity</td></tr><tr><td style=\"white-space:nowrap\">SAMP<a name=\"cs-local-codes-drug-pq-SAMP\"> </a></td><td>Number of Samples</td></tr><tr><td style=\"white-space:nowrap\">DGP<a name=\"cs-local-codes-drug-pq-DGP\"> </a></td><td>Degradation Products</td></tr><tr><td style=\"white-space:nowrap\">DGP-s<a name=\"cs-local-codes-drug-pq-DGP-s\"> </a></td><td>Drug Substance Related Organic impurities</td></tr><tr><td style=\"white-space:nowrap\">IMP<a name=\"cs-local-codes-drug-pq-IMP\"> </a></td><td>Impurity</td></tr><tr><td style=\"white-space:nowrap\">Impurities<a name=\"cs-local-codes-drug-pq-Impurities\"> </a></td><td>Impurities</td></tr><tr><td style=\"white-space:nowrap\">WWW<a name=\"cs-local-codes-drug-pq-WWW\"> </a></td><td>Water Content</td></tr><tr><td style=\"white-space:nowrap\">Microbiological Quality<a name=\"cs-local-codes-drug-pq-MicrobiologicalQuality\"> </a></td><td>Microbiological Quality</td></tr><tr><td style=\"white-space:nowrap\">ASSAY<a name=\"cs-local-codes-drug-pq-ASSAY\"> </a></td><td>Assay</td></tr><tr><td style=\"white-space:nowrap\">CEX-HPLCAcidicPeak<a name=\"cs-local-codes-drug-pq-CEX-HPLCAcidicPeak\"> </a></td><td>CEX-HPLC Acidic Peak</td></tr><tr><td style=\"white-space:nowrap\">CEX-HPLCMainPeak<a name=\"cs-local-codes-drug-pq-CEX-HPLCMainPeak\"> </a></td><td>CEX-HPLC Main Peak</td></tr><tr><td style=\"white-space:nowrap\">PART<a name=\"cs-local-codes-drug-pq-PART\"> </a></td><td>Particle size distribution</td></tr><tr><td style=\"white-space:nowrap\">ASSH<a name=\"cs-local-codes-drug-pq-ASSH\"> </a></td><td>Assay Content Homogeneity</td></tr><tr><td style=\"white-space:nowrap\">DESC<a name=\"cs-local-codes-drug-pq-DESC\"> </a></td><td>Description</td></tr><tr><td style=\"white-space:nowrap\">Dissolution<a name=\"cs-local-codes-drug-pq-Dissolution\"> </a></td><td>Dissolution</td></tr><tr><td style=\"white-space:nowrap\">Dissolution Quantity<a name=\"cs-local-codes-drug-pq-DissolutionQuantity\"> </a></td><td>Dissolution Quantity</td></tr><tr><td style=\"white-space:nowrap\">ELE<a name=\"cs-local-codes-drug-pq-ELE\"> </a></td><td>Elemental impurities</td></tr><tr><td style=\"white-space:nowrap\">enantiomeric-purity<a name=\"cs-local-codes-drug-pq-enantiomeric-purity\"> </a></td><td>Enantiomeric purity</td></tr><tr><td style=\"white-space:nowrap\">IDT<a name=\"cs-local-codes-drug-pq-IDT\"> </a></td><td>Identification</td></tr><tr><td style=\"white-space:nowrap\">MUT<a name=\"cs-local-codes-drug-pq-MUT\"> </a></td><td>Mutagenic impurities</td></tr><tr><td style=\"white-space:nowrap\">NMR<a name=\"cs-local-codes-drug-pq-NMR\"> </a></td><td>NMR</td></tr><tr><td style=\"white-space:nowrap\">NMR-C<a name=\"cs-local-codes-drug-pq-NMR-C\"> </a></td><td>NMR-C</td></tr><tr><td style=\"white-space:nowrap\">NMR-H<a name=\"cs-local-codes-drug-pq-NMR-H\"> </a></td><td>NMR-H</td></tr><tr><td style=\"white-space:nowrap\">CEX-HPLCAcidicPeak-15<a name=\"cs-local-codes-drug-pq-CEX-HPLCAcidicPeak-15\"> </a></td><td>CEX-HPLC Acidic Peak - 15</td></tr><tr><td style=\"white-space:nowrap\">CEX-HPLCAcidicPeak-25<a name=\"cs-local-codes-drug-pq-CEX-HPLCAcidicPeak-25\"> </a></td><td>CEX-HPLC Acidic Peak - 25</td></tr><tr><td style=\"white-space:nowrap\">CEX-HPLCMainPeak-15<a name=\"cs-local-codes-drug-pq-CEX-HPLCMainPeak-15\"> </a></td><td>CEX-HPLC Main Peak - 15</td></tr><tr><td style=\"white-space:nowrap\">CEX-HPLCMainPeak-25<a name=\"cs-local-codes-drug-pq-CEX-HPLCMainPeak-25\"> </a></td><td>CEX-HPLC Main Peak - 25</td></tr><tr><td style=\"white-space:nowrap\">Homogeneity<a name=\"cs-local-codes-drug-pq-Homogeneity\"> </a></td><td>Homogeneity demonstrated</td></tr><tr><td style=\"white-space:nowrap\">LCL<a name=\"cs-local-codes-drug-pq-LCL\"> </a></td><td>Lower one-sided 95% confidence limit of Max Difference</td></tr><tr><td style=\"white-space:nowrap\">LOC<a name=\"cs-local-codes-drug-pq-LOC\"> </a></td><td>Number of Locations</td></tr><tr><td style=\"white-space:nowrap\">PARTS<a name=\"cs-local-codes-drug-pq-PARTS\"> </a></td><td>Particle size</td></tr><tr><td style=\"white-space:nowrap\">POS<a name=\"cs-local-codes-drug-pq-POS\"> </a></td><td>Structure Position</td></tr><tr><td style=\"white-space:nowrap\">particle-size-distribution<a name=\"cs-local-codes-drug-pq-particle-size-distribution\"> </a></td><td>Particle size distribution</td></tr><tr><td style=\"white-space:nowrap\">Lyophilization Water Homogeneity<a name=\"cs-local-codes-drug-pq-LyophilizationWaterHomogeneity\"> </a></td><td>Lyophilization Water Homogeneity</td></tr><tr><td style=\"white-space:nowrap\">Lyophilization Assay Homogeneity<a name=\"cs-local-codes-drug-pq-LyophilizationAssayHomogeneity\"> </a></td><td>Lyophilization Assay Homogeneity</td></tr><tr><td style=\"white-space:nowrap\">Particle Size RSD<a name=\"cs-local-codes-drug-pq-ParticleSizeRSD\"> </a></td><td>Particle Size RSD</td></tr><tr><td style=\"white-space:nowrap\">Obscuration<a name=\"cs-local-codes-drug-pq-Obscuration\"> </a></td><td>Obscuration</td></tr><tr><td style=\"white-space:nowrap\">Refractive index<a name=\"cs-local-codes-drug-pq-Refractiveindex\"> </a></td><td>Refractive index</td></tr><tr><td style=\"white-space:nowrap\">ElementalAnalysisCarbon<a name=\"cs-local-codes-drug-pq-ElementalAnalysisCarbon\"> </a></td><td>Elemental Analysis Carbon (%)</td></tr><tr><td style=\"white-space:nowrap\">IonAnalysisCarbonMass<a name=\"cs-local-codes-drug-pq-IonAnalysisCarbonMass\"> </a></td><td>Ion Analysis Carbon - Mass</td></tr><tr><td style=\"white-space:nowrap\">IonAnalysisCarbonMassAccuracy<a name=\"cs-local-codes-drug-pq-IonAnalysisCarbonMassAccuracy\"> </a></td><td>Ion Analysis Carbon - Mass Accuracy</td></tr><tr><td style=\"white-space:nowrap\">IonAnalysisCarbon<a name=\"cs-local-codes-drug-pq-IonAnalysisCarbon\"> </a></td><td>Ion Analysis Carbon (%)</td></tr><tr><td style=\"white-space:nowrap\">ElementalAnalysisHydrogen<a name=\"cs-local-codes-drug-pq-ElementalAnalysisHydrogen\"> </a></td><td>Elemental Analysis Hydrogen (%)</td></tr><tr><td style=\"white-space:nowrap\">IonAnalysisHydrogenMass<a name=\"cs-local-codes-drug-pq-IonAnalysisHydrogenMass\"> </a></td><td>Ion Analysis Hydrogen - Mass</td></tr><tr><td style=\"white-space:nowrap\">IonAnalysisHydrogenMassAccuracy<a name=\"cs-local-codes-drug-pq-IonAnalysisHydrogenMassAccuracy\"> </a></td><td>Ion Analysis Hydrogen - Mass Accuracy</td></tr><tr><td style=\"white-space:nowrap\">IonAnalysisHydrogen<a name=\"cs-local-codes-drug-pq-IonAnalysisHydrogen\"> </a></td><td>Ion Analysis Hydrogen (%)</td></tr><tr><td style=\"white-space:nowrap\">ElementalAnalysisNitrogen<a name=\"cs-local-codes-drug-pq-ElementalAnalysisNitrogen\"> </a></td><td>Elemental Analysis Nitrogen (%)</td></tr><tr><td style=\"white-space:nowrap\">IonAnalysisNitrogen<a name=\"cs-local-codes-drug-pq-IonAnalysisNitrogen\"> </a></td><td>Ion Analysis Nitrogen (%)</td></tr><tr><td style=\"white-space:nowrap\">IonAnalysisNitrogenMass<a name=\"cs-local-codes-drug-pq-IonAnalysisNitrogenMass\"> </a></td><td>Ion Analysis Nitrogen - Mass</td></tr><tr><td style=\"white-space:nowrap\">IonAnalysisNitrogenMassAccuracy<a name=\"cs-local-codes-drug-pq-IonAnalysisNitrogenMassAccuracy\"> </a></td><td>Ion Analysis Nitrogen - Mass Accuracy</td></tr><tr><td style=\"white-space:nowrap\">ElementalAnalysisFlourine<a name=\"cs-local-codes-drug-pq-ElementalAnalysisFlourine\"> </a></td><td>Elemental Analysis Flourine (%)</td></tr><tr><td style=\"white-space:nowrap\">IonAnalysisFlourine<a name=\"cs-local-codes-drug-pq-IonAnalysisFlourine\"> </a></td><td>Ion Analysis Flourine (%)</td></tr><tr><td style=\"white-space:nowrap\">IonAnalysisFlourineMass<a name=\"cs-local-codes-drug-pq-IonAnalysisFlourineMass\"> </a></td><td>Ion Analysis Flourine - Mass</td></tr><tr><td style=\"white-space:nowrap\">IonAnalysisFlourineMassAccuracy<a name=\"cs-local-codes-drug-pq-IonAnalysisFlourineMassAccuracy\"> </a></td><td>Ion Analysis Flourine - Mass Accuracy</td></tr><tr><td style=\"white-space:nowrap\">Chemical Structure<a name=\"cs-local-codes-drug-pq-ChemicalStructure\"> </a></td><td>Chemical Structure</td></tr><tr><td style=\"white-space:nowrap\">Diffractogram<a name=\"cs-local-codes-drug-pq-Diffractogram\"> </a></td><td>Diffractogram</td></tr><tr><td style=\"white-space:nowrap\">MolecularStructure<a name=\"cs-local-codes-drug-pq-MolecularStructure\"> </a></td><td>Molecular Structure</td></tr><tr><td style=\"white-space:nowrap\">Absorption<a name=\"cs-local-codes-drug-pq-Absorption\"> </a></td><td>Absorption</td></tr><tr><td style=\"white-space:nowrap\">X-Ray Powder Diffractogram<a name=\"cs-local-codes-drug-pq-X-RayPowderDiffractogram\"> </a></td><td>X-Ray Powder Diffractogram</td></tr><tr><td style=\"white-space:nowrap\">pH (post-dilution bulk solution)<a name=\"cs-local-codes-drug-pq-pH.40post-dilutionbulksolution.41\"> </a></td><td>pH (post-dilution bulk solution)</td></tr><tr><td style=\"white-space:nowrap\">Appearance (Product Container, visual)<a name=\"cs-local-codes-drug-pq-Appearance.40ProductContainer.44visual.41\"> </a></td><td>Appearance (Product Container, visual)</td></tr><tr><td style=\"white-space:nowrap\">Appearance (Lyophilized, Visual)<a name=\"cs-local-codes-drug-pq-Appearance.40Lyophilized.44Visual.41\"> </a></td><td>Appearance (Lyophilized, Visual)</td></tr><tr><td style=\"white-space:nowrap\">Appearance (Reconstituted, Visual)<a name=\"cs-local-codes-drug-pq-Appearance.40Reconstituted.44Visual.41\"> </a></td><td>Appearance (Reconstituted, Visual)</td></tr><tr><td style=\"white-space:nowrap\">Appearance<a name=\"cs-local-codes-drug-pq-Appearance\"> </a></td><td>Appearance</td></tr><tr><td style=\"white-space:nowrap\">pH (reconstituted)<a name=\"cs-local-codes-drug-pq-pH.40reconstituted.41\"> </a></td><td>pH (reconstituted)</td></tr><tr><td style=\"white-space:nowrap\">TAMC<a name=\"cs-local-codes-drug-pq-TAMC\"> </a></td><td>TAMC</td></tr><tr><td style=\"white-space:nowrap\">Fill Weight Average<a name=\"cs-local-codes-drug-pq-FillWeightAverage\"> </a></td><td>Fill Weight Average</td></tr><tr><td style=\"white-space:nowrap\">Fill Weight Target (g)<a name=\"cs-local-codes-drug-pq-FillWeightTarget.40g.41\"> </a></td><td>Fill Weight Target (g)</td></tr><tr><td style=\"white-space:nowrap\">Actual Avg. Weight from Target<a name=\"cs-local-codes-drug-pq-ActualAvg.46WeightfromTarget\"> </a></td><td>Actual Avg. Weight from Target</td></tr><tr><td style=\"white-space:nowrap\">Hold Time (filtration To filling)<a name=\"cs-local-codes-drug-pq-HoldTime.40filtrationTofilling.41\"> </a></td><td>Hold Time (filtration To filling)</td></tr><tr><td style=\"white-space:nowrap\">Hold Time (start filling to end filling)<a name=\"cs-local-codes-drug-pq-HoldTime.40startfillingtoendfilling.41\"> </a></td><td>Hold Time (start filling to end filling)</td></tr><tr><td style=\"white-space:nowrap\">Filter Integrity Test<a name=\"cs-local-codes-drug-pq-FilterIntegrityTest\"> </a></td><td>Filter Integrity Test</td></tr><tr><td style=\"white-space:nowrap\">Lyophilizer Number<a name=\"cs-local-codes-drug-pq-LyophilizerNumber\"> </a></td><td>Lyophilizer Number</td></tr><tr><td style=\"white-space:nowrap\">pH (adjustment of pre-clarification bulk solution)<a name=\"cs-local-codes-drug-pq-pH.40adjustmentofpre-clarificationbulksolution.41\"> </a></td><td>pH (adjustment of pre-clarification bulk solution)</td></tr><tr><td style=\"white-space:nowrap\">Assay (pre-clarification filtration) (mg/mL)<a name=\"cs-local-codes-drug-pq-Assay.40pre-clarificationfiltration.41.40mg.47mL.41\"> </a></td><td>Assay (pre-clarification filtration) (mg/mL)</td></tr><tr><td style=\"white-space:nowrap\">Assay (Post dilution bulk solution) (mg/mL)<a name=\"cs-local-codes-drug-pq-Assay.40Postdilutionbulksolution.41.40mg.47mL.41\"> </a></td><td>Assay (Post dilution bulk solution) (mg/mL)</td></tr><tr><td style=\"white-space:nowrap\">Test Date<a name=\"cs-local-codes-drug-pq-TestDate\"> </a></td><td>Test Date</td></tr><tr><td style=\"white-space:nowrap\">Identification (NMR)<a name=\"cs-local-codes-drug-pq-Identification.40NMR.41\"> </a></td><td>Identification (NMR)</td></tr><tr><td style=\"white-space:nowrap\">Identification (FT-IR)<a name=\"cs-local-codes-drug-pq-Identification.40FT-IR.41\"> </a></td><td>Identification (FT-IR)</td></tr><tr><td style=\"white-space:nowrap\">VisualInspection<a name=\"cs-local-codes-drug-pq-VisualInspection\"> </a></td><td>VisualInspection</td></tr><tr><td style=\"white-space:nowrap\">InfraredSpectroscopy<a name=\"cs-local-codes-drug-pq-InfraredSpectroscopy\"> </a></td><td>InfraredSpectroscopy</td></tr><tr><td style=\"white-space:nowrap\">SupplierCertificateofAnalysis<a name=\"cs-local-codes-drug-pq-SupplierCertificateofAnalysis\"> </a></td><td>SupplierCertificateofAnalysis</td></tr><tr><td style=\"white-space:nowrap\">Elemental<a name=\"cs-local-codes-drug-pq-Elemental\"> </a></td><td>Elemental</td></tr><tr><td style=\"white-space:nowrap\">Uniformity of Dosage Units, Weight Variation<a name=\"cs-local-codes-drug-pq-UniformityofDosageUnits.44WeightVariation\"> </a></td><td>Uniformity of Dosage Units, Weight Variation</td></tr><tr><td style=\"white-space:nowrap\">Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)<a name=\"cs-local-codes-drug-pq-UniformityofDosageUnits.44WeightVariation-AcceptanceValue.40AV.41\"> </a></td><td>Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)</td></tr><tr><td style=\"white-space:nowrap\">Yield (%)<a name=\"cs-local-codes-drug-pq-Yield.40.37.41\"> </a></td><td>Yield (%)</td></tr><tr><td style=\"white-space:nowrap\">ResidualWaterContent<a name=\"cs-local-codes-drug-pq-ResidualWaterContent\"> </a></td><td>Residual Water Content (w/w%)</td></tr><tr><td style=\"white-space:nowrap\">Reaction conversion: Residual Starting Material 1 by HPLC<a name=\"cs-local-codes-drug-pq-Reactionconversion.58ResidualStartingMaterial1byHPLC\"> </a></td><td>Reaction conversion: Residual Starting Material 1 by HPLC</td></tr><tr><td style=\"white-space:nowrap\">Bacterial Endotoxins (EU/mL)<a name=\"cs-local-codes-drug-pq-BacterialEndotoxins.40EU.47mL.41\"> </a></td><td>Bacterial Endotoxins (EU/mL)</td></tr><tr><td style=\"white-space:nowrap\">Bioburden - Beginning<a name=\"cs-local-codes-drug-pq-Bioburden-Beginning\"> </a></td><td>Bioburden - Beginning</td></tr><tr><td style=\"white-space:nowrap\">Bioburden - End<a name=\"cs-local-codes-drug-pq-Bioburden-End\"> </a></td><td>Bioburden - End</td></tr><tr><td style=\"white-space:nowrap\">Bioburden (CFU/ 100 mL)<a name=\"cs-local-codes-drug-pq-Bioburden.40CFU.47100mL.41\"> </a></td><td>Bioburden (CFU/ 100 mL)</td></tr><tr><td style=\"white-space:nowrap\">Buffer vessel mixing speed (rpm)<a name=\"cs-local-codes-drug-pq-Buffervesselmixingspeed.40rpm.41\"> </a></td><td>Buffer vessel mixing speed (rpm)</td></tr><tr><td style=\"white-space:nowrap\">Buffer vessel mixing time (min)<a name=\"cs-local-codes-drug-pq-Buffervesselmixingtime.40min.41\"> </a></td><td>Buffer vessel mixing time (min)</td></tr><tr><td style=\"white-space:nowrap\">CONC<a name=\"cs-local-codes-drug-pq-CONC\"> </a></td><td>Conclusion</td></tr><tr><td style=\"white-space:nowrap\">Conductivity (μS/cm)<a name=\"cs-local-codes-drug-pq-Conductivity.40.956S.47cm.41\"> </a></td><td>Conductivity (μS/cm)</td></tr><tr><td style=\"white-space:nowrap\">Fill Weight<a name=\"cs-local-codes-drug-pq-FillWeight\"> </a></td><td>Fill Weight</td></tr><tr><td style=\"white-space:nowrap\">Fill Weight - Maximum<a name=\"cs-local-codes-drug-pq-FillWeight-Maximum\"> </a></td><td>Fill Weight - Maximum</td></tr><tr><td style=\"white-space:nowrap\">Fill Weight - Mean<a name=\"cs-local-codes-drug-pq-FillWeight-Mean\"> </a></td><td>Fill Weight - Mean</td></tr><tr><td style=\"white-space:nowrap\">Fill Weight - Minimum<a name=\"cs-local-codes-drug-pq-FillWeight-Minimum\"> </a></td><td>Fill Weight - Minimum</td></tr><tr><td style=\"white-space:nowrap\">FiltrationPressure (psig)<a name=\"cs-local-codes-drug-pq-FiltrationPressure.40psig.41\"> </a></td><td>FiltrationPressure (psig)</td></tr><tr><td style=\"white-space:nowrap\">Formulation vessel mixing speed (rpm)<a name=\"cs-local-codes-drug-pq-Formulationvesselmixingspeed.40rpm.41\"> </a></td><td>Formulation vessel mixing speed (rpm)</td></tr><tr><td style=\"white-space:nowrap\">Formulation vessel mixing time (min)<a name=\"cs-local-codes-drug-pq-Formulationvesselmixingtime.40min.41\"> </a></td><td>Formulation vessel mixing time (min)</td></tr><tr><td style=\"white-space:nowrap\">Growth Promotion - Beginning<a name=\"cs-local-codes-drug-pq-GrowthPromotion-Beginning\"> </a></td><td>Growth Promotion - Beginning</td></tr><tr><td style=\"white-space:nowrap\">Growth Promotion - End<a name=\"cs-local-codes-drug-pq-GrowthPromotion-End\"> </a></td><td>Growth Promotion - End</td></tr><tr><td style=\"white-space:nowrap\">GrowthPromotion<a name=\"cs-local-codes-drug-pq-GrowthPromotion\"> </a></td><td>Growth Promotion</td></tr><tr><td style=\"white-space:nowrap\">Hold Time<a name=\"cs-local-codes-drug-pq-HoldTime\"> </a></td><td>Hold Time</td></tr><tr><td style=\"white-space:nowrap\">LyophilizationHomogeneneity<a name=\"cs-local-codes-drug-pq-LyophilizationHomogeneneity\"> </a></td><td>Lyophilization Homogeneneity</td></tr><tr><td style=\"white-space:nowrap\">Media Challenge Hold Times<a name=\"cs-local-codes-drug-pq-MediaChallengeHoldTimes\"> </a></td><td>Media Challenge Hold Times</td></tr><tr><td style=\"white-space:nowrap\">MediaChallengeRun<a name=\"cs-local-codes-drug-pq-MediaChallengeRun\"> </a></td><td>Media Challenge Run</td></tr><tr><td style=\"white-space:nowrap\">Osmolality<a name=\"cs-local-codes-drug-pq-Osmolality\"> </a></td><td>Osmolality</td></tr><tr><td style=\"white-space:nowrap\">OVERALLSAMP<a name=\"cs-local-codes-drug-pq-OVERALLSAMP\"> </a></td><td>Number of Samples</td></tr><tr><td style=\"white-space:nowrap\">particle-size<a name=\"cs-local-codes-drug-pq-particle-size\"> </a></td><td>Particle Size</td></tr><tr><td style=\"white-space:nowrap\">pH<a name=\"cs-local-codes-drug-pq-pH\"> </a></td><td>pH</td></tr><tr><td style=\"white-space:nowrap\">Polysorbate 80 (% w/v)<a name=\"cs-local-codes-drug-pq-Polysorbate80.40.37w.47v.41\"> </a></td><td>Polysorbate 80 (% w/v)</td></tr><tr><td style=\"white-space:nowrap\">Polysorbate 80 concentration - Beginning - Max<a name=\"cs-local-codes-drug-pq-Polysorbate80concentration-Beginning-Max\"> </a></td><td>Polysorbate 80 concentration - Beginning - Max</td></tr><tr><td style=\"white-space:nowrap\">Polysorbate 80 concentration - Beginning - Min<a name=\"cs-local-codes-drug-pq-Polysorbate80concentration-Beginning-Min\"> </a></td><td>Polysorbate 80 concentration - Beginning - Min</td></tr><tr><td style=\"white-space:nowrap\">Polysorbate 80 concentration - End - Max<a name=\"cs-local-codes-drug-pq-Polysorbate80concentration-End-Max\"> </a></td><td>Polysorbate 80 concentration - End - Max</td></tr><tr><td style=\"white-space:nowrap\">Polysorbate 80 concentration - End - Min<a name=\"cs-local-codes-drug-pq-Polysorbate80concentration-End-Min\"> </a></td><td>Polysorbate 80 concentration - End - Min</td></tr><tr><td style=\"white-space:nowrap\">Polysorbate 80 concentration - Middle - Max<a name=\"cs-local-codes-drug-pq-Polysorbate80concentration-Middle-Max\"> </a></td><td>Polysorbate 80 concentration - Middle - Max</td></tr><tr><td style=\"white-space:nowrap\">Polysorbate 80 concentration - Middle - Min<a name=\"cs-local-codes-drug-pq-Polysorbate80concentration-Middle-Min\"> </a></td><td>Polysorbate 80 concentration - Middle - Min</td></tr><tr><td style=\"white-space:nowrap\">Polysorbate 80 concentration (% w/v)<a name=\"cs-local-codes-drug-pq-Polysorbate80concentration.40.37w.47v.41\"> </a></td><td>Polysorbate 80 concentration (% w/v)</td></tr><tr><td style=\"white-space:nowrap\">Post-filtration Filter Integrity (psig)<a name=\"cs-local-codes-drug-pq-Post-filtrationFilterIntegrity.40psig.41\"> </a></td><td>Post-filtration Filter Integrity (psig)</td></tr><tr><td style=\"white-space:nowrap\">Pre-filtration Bioburden (CFU/ 100 mL)<a name=\"cs-local-codes-drug-pq-Pre-filtrationBioburden.40CFU.47100mL.41\"> </a></td><td>Pre-filtration Bioburden (CFU/ 100 mL)</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration (mg/mL)<a name=\"cs-local-codes-drug-pq-ProteinConcentration.40mg.47mL.41\"> </a></td><td>Protein Concentration (mg/mL)</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration - Beginning - End - Higher<a name=\"cs-local-codes-drug-pq-ProteinConcentration-Beginning-End-Higher\"> </a></td><td>Protein Concentration - Beginning - End - Higher</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration - Beginning - End - Lower<a name=\"cs-local-codes-drug-pq-ProteinConcentration-Beginning-End-Lower\"> </a></td><td>Protein Concentration - Beginning - End - Lower</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration - Beginning - End - Mean<a name=\"cs-local-codes-drug-pq-ProteinConcentration-Beginning-End-Mean\"> </a></td><td>Protein Concentration - Beginning - End - Mean</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration - Beginning - Max<a name=\"cs-local-codes-drug-pq-ProteinConcentration-Beginning-Max\"> </a></td><td>Protein Concentration - Beginning - Max</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration - Beginning - Middle - Higher<a name=\"cs-local-codes-drug-pq-ProteinConcentration-Beginning-Middle-Higher\"> </a></td><td>Protein Concentration - Beginning - Middle - Higher</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration - Beginning - Middle - Lower<a name=\"cs-local-codes-drug-pq-ProteinConcentration-Beginning-Middle-Lower\"> </a></td><td>Protein Concentration - Beginning - Middle - Lower</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration - Beginning - Middle - Mean<a name=\"cs-local-codes-drug-pq-ProteinConcentration-Beginning-Middle-Mean\"> </a></td><td>Protein Concentration - Beginning - Middle - Mean</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration - Beginning - Min<a name=\"cs-local-codes-drug-pq-ProteinConcentration-Beginning-Min\"> </a></td><td>Protein Concentration - Beginning - Min</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration - Conclusion<a name=\"cs-local-codes-drug-pq-ProteinConcentration-Conclusion\"> </a></td><td>Protein Concentration - Conclusion</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration - End - Max<a name=\"cs-local-codes-drug-pq-ProteinConcentration-End-Max\"> </a></td><td>Protein Concentration - End - Max</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration - End - Min<a name=\"cs-local-codes-drug-pq-ProteinConcentration-End-Min\"> </a></td><td>Protein Concentration - End - Min</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration - Middle - End - Higher<a name=\"cs-local-codes-drug-pq-ProteinConcentration-Middle-End-Higher\"> </a></td><td>Protein Concentration - Middle - End - Higher</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration - Middle - End - Lower<a name=\"cs-local-codes-drug-pq-ProteinConcentration-Middle-End-Lower\"> </a></td><td>Protein Concentration - Middle - End - Lower</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration - Middle - End - Mean<a name=\"cs-local-codes-drug-pq-ProteinConcentration-Middle-End-Mean\"> </a></td><td>Protein Concentration - Middle - End - Mean</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration - Middle - Max<a name=\"cs-local-codes-drug-pq-ProteinConcentration-Middle-Max\"> </a></td><td>Protein Concentration - Middle - Max</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration - Middle - Min<a name=\"cs-local-codes-drug-pq-ProteinConcentration-Middle-Min\"> </a></td><td>Protein Concentration - Middle - Min</td></tr><tr><td style=\"white-space:nowrap\">Protein Concentration Statistics<a name=\"cs-local-codes-drug-pq-ProteinConcentrationStatistics\"> </a></td><td>Protein Concentration Statistics</td></tr><tr><td style=\"white-space:nowrap\">Residual Moisture - Max<a name=\"cs-local-codes-drug-pq-ResidualMoisture-Max\"> </a></td><td>Residual Moisture - Max</td></tr><tr><td style=\"white-space:nowrap\">Residual Moisture - Min<a name=\"cs-local-codes-drug-pq-ResidualMoisture-Min\"> </a></td><td>Residual Moisture - Min</td></tr><tr><td style=\"white-space:nowrap\">Residual Moisture<a name=\"cs-local-codes-drug-pq-ResidualMoisture\"> </a></td><td>Residual Moisture</td></tr><tr><td style=\"white-space:nowrap\">SE-UHPLC Main Peak - Beginning<a name=\"cs-local-codes-drug-pq-SE-UHPLCMainPeak-Beginning\"> </a></td><td>SE-UHPLC Main Peak - Beginning</td></tr><tr><td style=\"white-space:nowrap\">SE-UHPLC HMW - Conclusion<a name=\"cs-local-codes-drug-pq-SE-UHPLCHMW-Conclusion\"> </a></td><td>SE-UHPLC HMW - Conclusion</td></tr><tr><td style=\"white-space:nowrap\">SE-UHPLC Main Peak - Conclusion<a name=\"cs-local-codes-drug-pq-SE-UHPLCMainPeak-Conclusion\"> </a></td><td>SE-UHPLC Main Peak - Conclusion</td></tr><tr><td style=\"white-space:nowrap\">SE-UHPLC Main Peak - End<a name=\"cs-local-codes-drug-pq-SE-UHPLCMainPeak-End\"> </a></td><td>SE-UHPLC Main Peak - End</td></tr><tr><td style=\"white-space:nowrap\">SE-UHPLCHMW - Beginning<a name=\"cs-local-codes-drug-pq-SE-UHPLCHMW-Beginning\"> </a></td><td>SE-UHPLC HMW - Beginning</td></tr><tr><td style=\"white-space:nowrap\">SE-UHPLCHMW - End<a name=\"cs-local-codes-drug-pq-SE-UHPLCHMW-End\"> </a></td><td>SE-UHPLC HMW - End</td></tr><tr><td style=\"white-space:nowrap\">SE-UHPLCHMWPeak - Conclusion<a name=\"cs-local-codes-drug-pq-SE-UHPLCHMWPeak-Conclusion\"> </a></td><td>SE-UHPLC HMW Peak - Conclusion</td></tr><tr><td style=\"white-space:nowrap\">SE-UHPLCHMW<a name=\"cs-local-codes-drug-pq-SE-UHPLCHMW\"> </a></td><td>SE-UHPLC HMW</td></tr><tr><td style=\"white-space:nowrap\">SE-UHPLCMainPeak - Conclusion<a name=\"cs-local-codes-drug-pq-SE-UHPLCMainPeak-Conclusion\"> </a></td><td>SE-UHPLC Main Peak - Conclusion</td></tr><tr><td style=\"white-space:nowrap\">SE-UHPLCMainPeak<a name=\"cs-local-codes-drug-pq-SE-UHPLCMainPeak\"> </a></td><td>SE-UHPLC Main Peak</td></tr><tr><td style=\"white-space:nowrap\">test-success<a name=\"cs-local-codes-drug-pq-test-success\"> </a></td><td>Test Success</td></tr><tr><td style=\"white-space:nowrap\">Thaw Time<a name=\"cs-local-codes-drug-pq-ThawTime\"> </a></td><td>Thaw Time</td></tr><tr><td style=\"white-space:nowrap\">Thawing Temp<a name=\"cs-local-codes-drug-pq-ThawingTemp\"> </a></td><td>Thawing Temp</td></tr><tr><td style=\"white-space:nowrap\">WaterContent<a name=\"cs-local-codes-drug-pq-WaterContent\"> </a></td><td>Water content</td></tr><tr><td style=\"white-space:nowrap\">AssignedPurity<a name=\"cs-local-codes-drug-pq-AssignedPurity\"> </a></td><td>Assigned Purity</td></tr></table></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
}
],
"url" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"version" : "1.0.0-ballot",
"name" : "CsLocalCodesDrugPQ",
"title" : "CodeSystem - Example Local Codes - Drug",
"status" : "active",
"experimental" : false,
"date" : "2023-12-18T16:00:45+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"
}
]
}
],
"description" : "This code system contains temporary example codes for use in PQ.",
"jurisdiction" : [
{
"coding" : [
{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}
],
"text" : "World"
}
],
"caseSensitive" : true,
"content" : "complete",
"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"
}
]
}
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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QA Report
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