Generated Narrative: PlanDefinition Resource PlanDefinition "plandefinition-drug-pq-ex1-validation-protocol" url: http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f title: DP PROCESS VALIDATION type: Workflow Definition (PlanDefinitionType#workflow-definition; Pharmaceutical Plan Type Codes#process-validation "Process Validation") status: active subject: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5 description: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies... action title: Formulation Buffer Preparation Process Parameter Step code: Formulation Buffer Preparation Process Parameter Step (Manufacturing Step Codes#FormulationBufferPreparationProcessParameterStep) action title: Formulation Buffer Preparation Process Parameter Step code: FormulationBufferPreparationProcessParameterStep () action action action action title: Formulation Buffer Preparation Performance Indicator Results code: Formulation Buffer Preparation Performance Indicator Results (Manufacturing Step Codes#FormulationBufferPreparationPerformanceIndicatorStep) action title: ??? code: ??? () action action action action action action title: Thawing and Formulation Process Parameter Results code: Thawing and Formulation Process Parameter Resultss (Manufacturing Step Codes#ThawingandFormulationProcessParameterResultsStep) action title: ??? code: ??? () action action action action action title: Thawing and Formulation Performance Indicator Results code: Thawing and Formulation Performance Indicator Results (Manufacturing Step Codes#ThawingandFormulationPerformanceIndicatorResultsStep) action title: ??? code: ??? () action action action action action action title: Bioburden Reduction Filtration Process Parameter Results code: Bioburden Reduction Filtration Process Parameter Results (Manufacturing Step Codes#BioburdenReductionFiltrationProcessParameterResultsStep) Actions - Code Definition[x] * Test () http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434 action title: Bioburden Reduction Filtration Performance Indicator Results code: Bioburden Reduction Filtration Performance Indicator Results (Manufacturing Step Codes#BioburdenReductionFiltrationPerformanceIndicatorResultsStep) Actions - Code Definition[x] * Test () http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434 * Test () http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434 action title: Media Challenge Hold Times code: Media Challenge Hold Times (Manufacturing Step Codes#MediaChallengeHoldTimesStep) Actions - Code Definition[x] * Test () http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434 action title: Media Challenge Results code: Media Challenge Results (Manufacturing Step Codes#MediaChallengeResultsStep) Actions - Code Definition[x] * Test () http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524 * Test () http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524 action title: Filtered Formulated Drug Product Performance Indicator Results code: Filtered Formulated Drug Product Performance Indicator Results (Manufacturing Step Codes#FilteredFormulatedDrugProductPerformanceIndicatorResultsStep) Actions - Code Definition[x] * Test () http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424 * Test () http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424 * Test () http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424 action title: Fill Weight Summary code: Fill Weight Summary (Manufacturing Step Codes#FillWeightSummaryStep) Actions - Code Definition[x] * Test () http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524 action title: Filling Homogeneity Quality Attributes code: Filling Homogeneity Quality Attributes (Manufacturing Step Codes#FillingHomogeneityQualityAttributesStep) Actions - Code Definition[x] * Conclusion () http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424 action title: Filling Results Summary code: Filling Results Summary (Manufacturing Step Codes#FillingResultsSummaryStep) Actions - Code Definition[x] * Test () http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524 * Test () http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524 action title: Statistical Evaluation of Homogeneity Data code: Statistical Evaluation of Homogeneity Data (Manufacturing Step Codes#StatisticalEvaluationOfHomogeneityDataStep) Actions - Code Definition[x] * Test () http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534 * Test () http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524 action title: Consistency of the Lyophilization Process code: Consistency of the Lyophilization Process (Manufacturing Step Codes#ConsistencyoftheLyophilizationProcessStep) Actions - Code Definition[x] * Test () http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72 * Definition () Lyophilization action title: Lyophilization Homogeneity code: Lyophilization Homogeneity Results (Manufacturing Step Codes#LyophilizationHomogeneityStep) Actions - Code Definition[x] * Test () http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424 * Test () http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424
Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...
Formulation Buffer Preparation Process Parameter Step
Formulation Buffer Preparation Performance Indicator Results
Thawing and Formulation Process Parameter Results
Thawing and Formulation Process Parameter Resultss
Thawing and Formulation Performance Indicator Results
Bioburden Reduction Filtration Process Parameter Results
Bioburden Reduction Filtration Performance Indicator Results
Filtered Formulated Drug Product Performance Indicator Results
Statistical Evaluation of Homogeneity Data
Consistency of the Lyophilization Process
Generated Narrative: ActivityDefinition Resource ActivityDefinition "b664977d-799d-a1ce-928a-6def2a9955bd" url: http://example-server.com/fhir/ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bd title: Lyophilization status: active
Generated Narrative: Organization Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b08" identifier: urn:oid:2.16.840.1.113883.4.82/3007270600 active: true type: Analytical Testing - Release (Pharmaceutical Organization Type Codes#analytical-testing-release) name: Testing Lab
Generated Narrative: DiagnosticReport Resource DiagnosticReport "processValidationReport" Triggered by: PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f status: final code: Process Validation Report (Pharmaceutical Report Type Codes#Process Validation Report) effective: 2020-12 result: See on this page: Observation/9c56948a-2a39-6609-1c01-4d197ea57a33 See on this page: Observation/9c56948a-3a39-6609-1c01-4d197ea57a33 See on this page: Observation/9c56948a-4a39-6609-1c01-4d197ea57a33 See on this page: Observation/9c56948a-2a39-6609-2c01-4d197ea57a33 See on this page: Observation/9c56948a-3a39-6609-2c01-4d197ea57a33 See on this page: Observation/9c56948a-4a39-6609-3c01-4d197ea57a33 See on this page: Observation/44aa47fd-8964-4f96-6495-b2bec7f160e7 See on this page: Observation/54aa47fd-8964-4f96-6495-b2bec7f160e7 See on this page: Observation/54aa48fd-8964-4f96-6495-b2bec7f160e7 See on this page: Observation/44aa47fd-8964-4f96-6495-b2bec7f161e7 See on this page: Observation/54aa47fd-8964-4f96-6495-b2bec7f162e7 See on this page: Observation/54aa48fd-8964-4f96-6495-b2bec7f163e7 See on this page: Observation/44aa47fd-8964-5f96-6495-b2bec7f161e7 See on this page: Observation/44aa47fd-9964-5f96-6495-b2bec7f161e8 See on this page: Observation/44aa47fd-8964-5f96-6495-b2bec7f161e8 See on this page: Observation/44aa47fd-8964-5f96-7495-b2bec7f161e8 See on this page: Observation/44aa47fd-9964-5f97-6495-b2bec7f161e8 See on this page: Observation/44aa47fd-8964-5f98-6495-b2bec7f161e8 See on this page: Observation/44aa47fd-8964-5f99-7495-b2bec7f161e8 See on this page: Observation/54aa47fd-9964-5f97-6495-b2bec7f161e8 See on this page: Observation/64aa47fd-8964-5f98-6495-b2bec7f161e8 See on this page: Observation/74aa47fd-8964-5f99-7495-b2bec7f161e8 See on this page: Observation/44ba47fd-8964-4f96-6495-b2bec7f161e7 See on this page: Observation/54ca47fd-8964-4f96-6495-b2bec7f162e7 See on this page: Observation/54da48fd-8964-4f96-6495-b2bec7f163e7 See on this page: Observation/44ba47fd-8964-5f96-6495-b2bec7f161e7 See on this page: Observation/44ba47fd-8964-4f97-6495-b2bec7f161e7 See on this page: Observation/54ca47fd-8964-4f98-6495-b2bec7f162e7 See on this page: Observation/54da48fd-8964-4f99-6495-b2bec7f163e7 See on this page: Observation/55aa47fd-9964-5f97-6495-b2bec7f161e8 See on this page: Observation/45aa47fd-8964-4f96-6495-b2bec7f160f7 See on this page: Observation/54aa47fd-9964-5f97-6495-b2bec8f161e8 See on this page: Observation/54aa47fd-9964-5f97-6495-b2bec8f162e8 See on this page: Observation/54aa47fd-9965-5f97-6495-b2bec8f161e8 See on this page: Observation/44ba47fd-8964-4f96-6495-b2bec7f161e8 See on this page: Observation/44ba47fd-9964-4f96-6495-b2bec7f161e8 See on this page: Observation/44ba47fd-9964-4f96-6496-b2bec7f161e8 See on this page: Observation/54ba47fd-8964-4f96-6495-b2bec7f161e7 See on this page: Observation/54ba47fd-8964-4f96-6495-b2bec7f161e8 See on this page: Observation/54ba47fd-8964-4f96-6495-b2bec7f161e9 See on this page: Observation/54ba48fd-8964-4f96-6495-b2bec7f161e7 See on this page: Observation/54bb47fd-8964-4f96-6495-b2bec7f161e7 See on this page: Observation/54ba47fd-9964-4f96-6495-b2bec7f161e8 See on this page: Observation/54ba47fe-8964-4f96-6495-b2bec7f161e9 See on this page: Observation/64ba48fd-8964-4f96-6495-b2bec7f161e7 conclusion: The samples have been assessed and the conclusion is...
The samples have been assessed and the conclusion is...
Generated Narrative: ObservationDefinition Resource ObservationDefinition "fd17b5d6-9fe1-91c2-2d06-47cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72 title: Buffer vessel mixing speed (rpm) status: active code: Buffer vessel mixing speed (rpm) (Example Local Codes - Drug#Buffer vessel mixing speed (rpm)) QualifiedValues - Range * 150-250 rpm
Generated Narrative: ObservationDefinition Resource ObservationDefinition "fc17b5d5-9fe1-91c2-2d06-47cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72 title: Formulation vessel mixing speed (rpm) status: active code: Formulation vessel mixing speed (rpm) (Example Local Codes - Drug#Formulation vessel mixing speed (rpm)) QualifiedValues - Range * 150-250 rpm
Generated Narrative: ObservationDefinition Resource ObservationDefinition "fc17b5d5-9fe1-91c2-2d06-47cb5b295e73" url: http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73 title: Buffer vessel mixing time (min) status: active code: Buffer vessel mixing time (min) (Example Local Codes - Drug#Buffer vessel mixing time (min)) QualifiedValues - Range * 45-55 mins
Generated Narrative: ObservationDefinition Resource ObservationDefinition "fc27b5d5-9fe1-92c2-2d06-47cb5b295e73" url: http://example-server.com/fhir/ObservationDefinition/fc27b5d5-9fe1-92c2-2d06-47cb5b295e73 title: Formulation vessel mixing time (min) status: active code: Formulation vessel mixing time (min) (Example Local Codes - Drug#Formulation vessel mixing time (min)) QualifiedValues - Range * 45-55 mins
Generated Narrative: ObservationDefinition Resource ObservationDefinition "fc27b6d6-9fe2-91c2-2d16-47cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72 title: Residual Moisture (%) status: active code: ResidualMoisture (Example Local Codes - Drug#Residual Moisture "Residual Moisture") QualifiedValues - Range * ?-7.15 component code: Residual Moisture - Min (Example Local Codes - Drug#Residual Moisture - Min) component code: Residual Moisture - Max (Example Local Codes - Drug#Residual Moisture - Max) component code: Number of Samples (Example Local Codes - Drug#SAMP)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "fc27b5d6-9fe1-91c2-2d16-47cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-47cb5b295e72 title: pH status: active code: pH (Example Local Codes - Drug#pH) QualifiedValues - Range * 6.55-7.15 pH
Generated Narrative: ObservationDefinition Resource ObservationDefinition "fc27b5d6-9fe2-91c2-2d16-47cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe2-91c2-2d16-47cb5b295e72 title: Thaw Time status: active code: Thaw Time (hr) (Example Local Codes - Drug#Thaw Time "Thaw Time") QualifiedValues - Range * ?-3
Generated Narrative: ObservationDefinition Resource ObservationDefinition "fc17b5d6-9fe1-91c2-2d16-47cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72 title: pH status: active code: pH (Example Local Codes - Drug#pH) QualifiedValues - Range * 6.95-7.05 pH
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64525a3c-5034-448a-9c19-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424 title: Osmolality status: active code: Osmolality (mOsm/kg) (Example Local Codes - Drug#Osmolality "Osmolality") QualifiedValues - Range * 250-300 mOsm/kg
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64525a3d-5134-448a-9c19-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424 title: SE-UHPLC Main Peak status: active code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak") QualifiedValues - Extension Range * 85-95 % component code: SE-UHPLC Main Peak - Conclusion (Example Local Codes - Drug#SE-UHPLC Main Peak - Conclusion) QualifiedValues - Extension * component code: Number of Samples (Example Local Codes - Drug#OVERALLSAMP)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64525a3d-5144-448a-9c19-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424 title: SE-UHPLC HMW status: active code: SE-UHPLC HMW (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW") QualifiedValues - Extension Range * 88-92 % component code: SE-UHPLC HMW - Conclusion (Example Local Codes - Drug#SE-UHPLC HMW - Conclusion) QualifiedValues - Extension * component code: Number of Samples (Example Local Codes - Drug#OVERALLSAMP)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64525a3d-5034-448a-9c19-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424 title: SE-UHPLC Main Peak status: active code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak") QualifiedValues - Range * 5-? %
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64525a4d-5034-448a-9c19-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424 title: SE-UHPLC Main Peak Graph status: active code: SE-UHPLC Main Peak (graph) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64525a33-5034-448a-9c19-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424 title: SE-UHPLC HMW status: active code: SE-UHPLC HMW (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW") QualifiedValues - Range * 7-? %
Generated Narrative: ObservationDefinition Resource ObservationDefinition "22515a3c-5034-448a-9c19-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424 title: Conclusion status: active code: Conclusion (Example Local Codes - Drug#CONC)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "22525a3c-5035-448a-9c19-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424 title: Conclusion status: active code: Conclusion (Example Local Codes - Drug#CONC)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64515a3c-5034-448a-9c19-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424 title: Osmolality status: active code: Osmolality (mOsm/kg) (Example Local Codes - Drug#Osmolality "Osmolality") QualifiedValues - Range * 240-310 mOsm/kg
Generated Narrative: ObservationDefinition Resource ObservationDefinition "74515a3c-5034-448a-9c19-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/74515a3c-5034-448a-9c19-938ce1958424 title: Thawing Temp status: active code: Thawing Temp (°C) (Example Local Codes - Drug#Thawing Temp "Thawing Temp") QualifiedValues - Range * 20-24 °C
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64515a3c-5134-448a-9c19-939ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-939ce1958424 title: Conductivity status: active code: Conductivity (μS/cm) (Example Local Codes - Drug#Conductivity (μS/cm)) QualifiedValues - Range * 150-200 μS/cm
Generated Narrative: ObservationDefinition Resource ObservationDefinition "74515a3c-5134-448a-9c19-939ce1958424" url: http://example-server.com/fhir/ObservationDefinition/74515a3c-5134-448a-9c19-939ce1958424 title: Conductivity status: active code: Conductivity (μS/cm) (Example Local Codes - Drug#Conductivity (μS/cm)) QualifiedValues - Range * 150-200 μS/cm
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64515b3c-5134-448a-9c19-939ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958424 title: Bioburden status: active code: Bioburden (CFU/ 100 mL) (Example Local Codes - Drug#Bioburden (CFU/ 100 mL)) QualifiedValues - Range * 50-150 CFU/ 100 mL
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64515b3c-5134-448a-9c19-939ce1958524" url: http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524 title: Bioburden status: active code: Bioburden (CFU/ 100 mL) (Example Local Codes - Drug#Bioburden (CFU/ 100 mL)) QualifiedValues - Range * ?-10 component code: Bioburden - Beginning (Example Local Codes - Drug#Bioburden - Beginning) component code: Bioburden - End (Example Local Codes - Drug#Bioburden - End)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "74515b3c-5234-448a-9c19-939ce1958524" url: http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524 title: Polysorbate 80 Concentration status: active code: Polysorbate 80 concentration - Middle - Max (Example Local Codes - Drug#Polysorbate 80 concentration - Middle - Max) QualifiedValues - Range * 0.5-1.5 % w/v component code: Polysorbate 80 concentration - Beginning - Min (Example Local Codes - Drug#Polysorbate 80 concentration - Beginning - Min) component code: Polysorbate 80 concentration - Beginning - Max (Example Local Codes - Drug#Polysorbate 80 concentration - Beginning - Max) component code: Polysorbate 80 concentration - Middle - Min (Example Local Codes - Drug#Polysorbate 80 concentration - Middle - Min) component code: Polysorbate 80 concentration - Middle - Max (Example Local Codes - Drug#Polysorbate 80 concentration - Middle - Max) component code: Polysorbate 80 concentration - End - Min (Example Local Codes - Drug#Polysorbate 80 concentration - End - Min) component code: Polysorbate 80 concentration - End - Max (Example Local Codes - Drug#Polysorbate 80 concentration - End - Max)
Polysorbate 80 concentration - Middle - Max
Polysorbate 80 concentration - Beginning - Min
Polysorbate 80 concentration - Beginning - Max
Polysorbate 80 concentration - Middle - Min
Polysorbate 80 concentration - End - Min
Polysorbate 80 concentration - End - Max
Generated Narrative: ObservationDefinition Resource ObservationDefinition "74515b3c-5134-448a-9c19-939ce1958524" url: http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524 title: Protein Concentration status: active code: Protein Concentration (mg/mL) (Example Local Codes - Drug#Protein Concentration (mg/mL)) QualifiedValues - Range * 8-10 (mg/mL) component code: Protein Concentration - Beginning - Min (Example Local Codes - Drug#Protein Concentration - Beginning - Min) component code: Protein Concentration - Beginning - Max (Example Local Codes - Drug#Protein Concentration - Beginning - Max) component code: Protein Concentration - Middle - Min (Example Local Codes - Drug#Protein Concentration - Middle - Min) component code: Protein Concentration - Middle - Max (Example Local Codes - Drug#Protein Concentration - Middle - Max) component code: Protein Concentration - End - Min (Example Local Codes - Drug#Protein Concentration - End - Min) component code: Protein Concentration - End - Max (Example Local Codes - Drug#Protein Concentration - End - Max)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "74515b3c-5134-448a-9c19-939ce1958534" url: http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534 title: Protein Concentration Stats status: active code: Protein Concentration Statistics (Example Local Codes - Drug#Protein Concentration Statistics) QualifiedValues - Range * 8-10 (mg/mL) component code: Protein Concentration - Beginning - Middle - Mean (Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Mean) component code: Protein Concentration - Beginning - End - Mean (Example Local Codes - Drug#Protein Concentration - Beginning - End - Mean) component code: Protein Concentration - Middle - End - Mean (Example Local Codes - Drug#Protein Concentration - Middle - End - Mean) component code: Protein Concentration - Beginning - Middle - Lower (Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Lower) component code: Protein Concentration - Beginning - End - Lower (Example Local Codes - Drug#Protein Concentration - Beginning - End - Lower) component code: Protein Concentration - Middle - End - Lower (Example Local Codes - Drug#Protein Concentration - Middle - End - Lower) component code: Protein Concentration - Beginning - Middle - Higher (Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Higher) component code: Protein Concentration - Beginning - End - Higher (Example Local Codes - Drug#Protein Concentration - Beginning - End - Higher) component code: Protein Concentration - Middle - End - Higher (Example Local Codes - Drug#Protein Concentration - Middle - End - Higher) component code: Protein Concentration - Conclusion (Example Local Codes - Drug#Protein Concentration - Conclusion)
Protein Concentration - Beginning - Middle - Mean
Protein Concentration - Beginning - End - Mean
Protein Concentration - Middle - End - Mean
Protein Concentration - Beginning - Middle - Lower
Protein Concentration - Beginning - End - Lower
Protein Concentration - Middle - End - Lower
Protein Concentration - Beginning - Middle - Higher
Protein Concentration - Beginning - End - Higher
Protein Concentration - Middle - End - Higher
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64515b3c-5134-448a-9c19-939ce2958524" url: http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524 title: Fill Weight status: active code: Fill Weight (Example Local Codes - Drug#Fill Weight) QualifiedValues - Extension Range * 95-105 g component code: Bioburden - Beginning (Example Local Codes - Drug#Bioburden - Beginning) component code: Bioburden - End (Example Local Codes - Drug#Bioburden - End)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64515b3c-5134-448a-9d19-939ce1958524" url: http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524 title: Growth Promotion status: active code: Growth Promotion (Example Local Codes - Drug#GrowthPromotion) QualifiedValues - Extension * component code: Growth Promotion - Beginning (Example Local Codes - Drug#Growth Promotion - Beginning) component code: Growth Promotion - End (Example Local Codes - Drug#Growth Promotion - End)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64515b3c-5134-448a-9c19-939ce1958434" url: http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434 title: Pre-filtration Bioburden status: active code: Pre-filtration Bioburden (CFU/ 100 mL) (Example Local Codes - Drug#Pre-filtration Bioburden (CFU/ 100 mL)) QualifiedValues - Range * ?-150
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64515b3c-5134-448a-9c19-949ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958424 title: Bacterial Endotoxins status: active code: Bacterial Endotoxins (EU/mL) (Example Local Codes - Drug#Bacterial Endotoxins (EU/mL)) QualifiedValues - Range * 40-120 EU/mL
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64515b4c-5134-448a-9c19-949ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64515b4c-5134-448a-9c19-949ce1958424 title: Bacterial Endotoxins status: active code: Bacterial Endotoxins (EU/mL) (Example Local Codes - Drug#Bacterial Endotoxins (EU/mL)) QualifiedValues - Range * 50-110 EU/mL
Generated Narrative: ObservationDefinition Resource ObservationDefinition "74515b3c-5134-448a-9c19-949ce1958434" url: http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434 title: Filtration Pressure status: active code: FiltrationPressure (psig) (Example Local Codes - Drug#FiltrationPressure (psig)) QualifiedValues - Range * 100-150 psig
Generated Narrative: ObservationDefinition Resource ObservationDefinition "75515b3c-5134-448a-9c19-949ce1958434" url: http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434 title: Post-filtration Filter Integrity (psig) status: active code: Post-filtration Filter Integrity (psig) (Example Local Codes - Drug#Post-filtration Filter Integrity (psig)) QualifiedValues - Range * 100-? psig Components - Code * Test Success (Example Local Codes - Drug#test-success)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "75515c3c-5134-448a-9c19-949ce1958434" url: http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434 title: Media Challenge Hold Times (hours) status: active code: Media Challenge Hold Times (Example Local Codes - Drug#Media Challenge Hold Times)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64515b3c-5134-448a-9c19-949ce1958434" url: http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958434 title: Polysorbate 80 status: active code: Polysorbate 80 (% w/v) (Example Local Codes - Drug#Polysorbate 80 (% w/v)) QualifiedValues - Range * 25-55 % w/v
Generated Narrative: Medication Resource Medication "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51" code: () Batches - Extension LotNumber * , , , , , , , , , , , , 999909 Generated Narrative: PackagedProductDefinition #ppd1-nosubject containedItemQuantity: 20 ml
Generated Narrative: Medication Resource Medication "339b69fd-4ab1-a1e9-9ea5-1973ba2f6b51" code: () Batches - Extension LotNumber * , , , , , , , , , , 999910 Generated Narrative: PackagedProductDefinition #ppd1-nosubject containedItemQuantity: 50 ml
Generated Narrative: Medication Resource Medication "a9dfda53-734b-045f-7ae4-94a6281d53bc" code: () Batches - Extension LotNumber * , , , , , , , , , , 999911 Generated Narrative: PackagedProductDefinition #ppd1-nosubject containedItemQuantity: 20 ml
Generated Narrative: Medication Resource Medication "a9dfda53-734b-045f-7ae5-94a6281d53bc" code: () Batches - Extension LotNumber * , , , , , , , , , , 999912 Generated Narrative: PackagedProductDefinition #ppd1-nosubject containedItemQuantity: 50 ml
Generated Narrative: Medication Resource Medication "c6f5fadd-62e6-3a01-93d9-b3b182f67d06" code: () Batches - Extension LotNumber * , , , , , , , , , , 999913 Generated Narrative: PackagedProductDefinition #ppd1-nosubject containedItemQuantity: 20 ml
Generated Narrative: Medication Resource Medication "c6f5fadd-62e6-3a11-93d9-b3b182f67d06" code: () Batches - Extension LotNumber * , , , , , , , , , , 999914 Generated Narrative: PackagedProductDefinition #ppd1-nosubject containedItemQuantity: 50 ml
Generated Narrative: Organization Resource Organization "0102bca4-46c1-a6bf-1025-cd403fee710a" identifier: urn:oid:2.16.840.1.113883.4.82/3010027650 active: true type: Drug Product Manufacture (Pharmaceutical Organization Type Codes#drug-product-manufacture) name: AAA Pharmaceutical, Inc. Contacts - Address * 681 Main Street Lumberton New Jersey 08048 USA
Generated Narrative: Organization Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b07" identifier: urn:oid:2.16.840.1.113883.4.82/3008816891 active: true type: Packaging (Pharmaceutical Organization Type Codes#packaging) name: MySite
Generated Narrative: Observation Resource Observation "9c56948a-2a39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72 status: final code: Buffer vessel mixing speed (rpm) (Example Local Codes - Drug#Buffer vessel mixing speed (rpm)) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 205 rpm
Generated Narrative: Observation Resource Observation "9c56948a-3a39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72 status: final code: Buffer vessel mixing speed (rpm) (Example Local Codes - Drug#Buffer vessel mixing speed (rpm)) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 210 rpm
Generated Narrative: Observation Resource Observation "9c56948a-4a39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72 status: final code: Buffer vessel mixing speed (rpm) (Example Local Codes - Drug#Buffer vessel mixing speed (rpm)) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 198 rpm
Generated Narrative: Observation Resource Observation "9c56948a-2a39-6609-2c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73 status: final code: Buffer vessel mixing time (min) (Example Local Codes - Drug#Buffer vessel mixing time (min)) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 51 mins
Generated Narrative: Observation Resource Observation "9c56948a-3a39-6609-2c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73 status: final code: Buffer vessel mixing time (min) (Example Local Codes - Drug#Buffer vessel mixing time (min)) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 49 mins
Generated Narrative: Observation Resource Observation "9c56948a-4a39-6609-3c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73 status: final code: Buffer vessel mixing time (min) (Example Local Codes - Drug#Buffer vessel mixing time (min)) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 52 mins
Generated Narrative: Observation Resource Observation "44aa47fd-8964-4f96-6495-b2bec7f160e7" instantiates: See on this page: ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72 status: final code: pH (Example Local Codes - Drug#pH) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 6.9 pH
Generated Narrative: Observation Resource Observation "54aa47fd-8964-4f96-6495-b2bec7f160e7" instantiates: See on this page: ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72 status: final code: pH (Example Local Codes - Drug#pH) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 7.1 pH
Generated Narrative: Observation Resource Observation "54aa48fd-8964-4f96-6495-b2bec7f160e7" instantiates: See on this page: ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72 status: final code: pH (Example Local Codes - Drug#pH) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 7.2 pH
Generated Narrative: Observation Resource Observation "44aa47fd-9964-5f96-6495-b2bec7f161e8" instantiates: See on this page: ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434 status: final code: Hold Time (hr) (Example Local Codes - Drug#Hold Time "Hold Time") subject: See on this page: Procedure/44aa47fd-8964-5f96-8495-b2bec7f161a8 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 1.25 hours
Generated Narrative: Observation Resource Observation "44aa47fd-8964-5f96-6495-b2bec7f161e8" instantiates: See on this page: ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434 status: final code: Hold Time (hr) (Example Local Codes - Drug#Hold Time "Hold Time") subject: See on this page: Procedure/44aa47fd-8964-5f96-6495-b2bec7f162a8 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 1.5 hours
Generated Narrative: Observation Resource Observation "44aa47fd-8964-5f96-7495-b2bec7f161e8" instantiates: See on this page: ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434 status: final code: Hold Time (hr) (Example Local Codes - Drug#Hold Time "Hold Time") subject: See on this page: Procedure/44aa47fd-8964-5f96-6495-b2bec7f163a8 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 1.75 hours
Generated Narrative: Observation Resource Observation "44aa47fd-9964-5f97-6495-b2bec7f161e8" instantiates: See on this page: ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524 status: final code: Bioburden (CFU/ 100 mL) (Example Local Codes - Drug#Bioburden (CFU/ 100 mL)) subject: See on this page: Procedure/44aa47fd-8964-5f96-8495-b2bec7f161a8 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: Bioburden - Beginning (Example Local Codes - Drug#Bioburden - Beginning) value: 8.0 CFU/100 mL component code: Bioburden - End (Example Local Codes - Drug#Bioburden - End) value: 9.0 CFU/100 mL
Generated Narrative: Observation Resource Observation "44aa47fd-8964-5f98-6495-b2bec7f161e8" instantiates: See on this page: ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524 status: final code: Bioburden (CFU/ 100 mL) (Example Local Codes - Drug#Bioburden (CFU/ 100 mL)) subject: See on this page: Procedure/44aa47fd-8964-5f96-6495-b2bec7f162a8 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: Bioburden - Beginning (Example Local Codes - Drug#Bioburden - Beginning) value: 8.5 CFU/100 mL component code: Bioburden - End (Example Local Codes - Drug#Bioburden - End) value: 8.6 CFU/100 mL
Generated Narrative: Observation Resource Observation "44aa47fd-8964-5f99-7495-b2bec7f161e8" instantiates: See on this page: ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524 status: final code: Bioburden (CFU/ 100 mL) (Example Local Codes - Drug#Bioburden (CFU/ 100 mL)) subject: See on this page: Procedure/44aa47fd-8964-5f96-6495-b2bec7f163a8 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: Bioburden - Beginning (Example Local Codes - Drug#Bioburden - Beginning) value: 9.5 CFU/100 mL component code: Bioburden - End (Example Local Codes - Drug#Bioburden - End) value: 10.1 CFU/100 mL
Generated Narrative: Observation Resource Observation "54aa47fd-9965-5f97-6495-b2bec8f161e8" instantiates: See on this page: ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534 status: final code: Protein Concentration (mg/mL) (Example Local Codes - Drug#Protein Concentration (mg/mL)) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: Protein Concentration - Beginning - Middle - Mean (Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Mean) value: 8.0 mg/mL component code: Protein Concentration - Beginning - End - Mean (Example Local Codes - Drug#Protein Concentration - Beginning - End - Mean) value: 8.05 mg/mL component code: Protein Concentration - Middle - End - Mean (Example Local Codes - Drug#Protein Concentration - Middle - End - Mean) value: 8.10 mg/mL component code: Protein Concentration - Beginning - Middle - Lower (Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Lower) value: 8.15 mg/mL component code: Protein Concentration - Beginning - End - Lower (Example Local Codes - Drug#Protein Concentration - Beginning - End - Lower) value: 8.2 mg/mL component code: Protein Concentration - Middle - End - Lower (Example Local Codes - Drug#Protein Concentration - Middle - End - Lower) value: 8.25 mg/mL component code: Protein Concentration - Beginning - Middle - Higher (Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Higher) value: 8.45 mg/mL component code: Protein Concentration - Beginning - End - Higher (Example Local Codes - Drug#Protein Concentration - Beginning - End - Higher) value: 8.3 mg/mL component code: Protein Concentration - Middle - End - Higher (Example Local Codes - Drug#Protein Concentration - Middle - End - Higher) value: 8.35 mg/mL component code: Protein Concentration - Conclusion (Example Local Codes - Drug#Protein Concentration - Conclusion) value: Pass
Generated Narrative: Observation Resource Observation "54aa47fd-9964-5f97-6495-b2bec8f161e8" instantiates: See on this page: ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524 status: final code: Protein Concentration (mg/mL) (Example Local Codes - Drug#Protein Concentration (mg/mL)) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: Protein Concentration - Beginning - Min (Example Local Codes - Drug#Protein Concentration - Beginning - Min) value: 8.00 mg/mL component code: Protein Concentration - Beginning - Max (Example Local Codes - Drug#Protein Concentration - Beginning - Max) value: 8.05 mg/mL component code: Protein Concentration - Middle - Min (Example Local Codes - Drug#Protein Concentration - Middle - Min) value: 8.10 mg/mL component code: Protein Concentration - Middle - Max (Example Local Codes - Drug#Protein Concentration - Middle - Max) value: 8.15 mg/mL component code: Protein Concentration - End - Min (Example Local Codes - Drug#Protein Concentration - End - Min) value: 8.2 mg/mL component code: Protein Concentration - End - Max (Example Local Codes - Drug#Protein Concentration - End - Max) value: 8.25 mg/mL
Generated Narrative: Observation Resource Observation "54aa47fd-9964-5f97-6495-b2bec8f162e8" instantiates: See on this page: ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524 status: final code: Polysorbate 80 concentration (% w/v) (Example Local Codes - Drug#Polysorbate 80 concentration (% w/v)) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: Polysorbate 80 concentration - Beginning - Min (Example Local Codes - Drug#Polysorbate 80 concentration - Beginning - Min) value: 1.0 % w/v component code: Polysorbate 80 concentration - Beginning - Max (Example Local Codes - Drug#Polysorbate 80 concentration - Beginning - Max) value: 1.05 % w/v component code: Polysorbate 80 concentration - Middle - Min (Example Local Codes - Drug#Polysorbate 80 concentration - Middle - Min) value: 1.10 % w/v component code: Polysorbate 80 concentration - Middle - Max (Example Local Codes - Drug#Polysorbate 80 concentration - Middle - Max) value: 1.15 % w/v component code: Polysorbate 80 concentration - End - Min (Example Local Codes - Drug#Polysorbate 80 concentration - End - Min) value: 1.2 % w/v component code: Polysorbate 80 concentration - End - Max (Example Local Codes - Drug#Polysorbate 80 concentration - End - Max) value: 1.25 % w/v
Generated Narrative: Observation Resource Observation "54aa47fd-9964-5f97-6495-b2bec7f161e8" instantiates: See on this page: ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524 status: final code: Growth Promotion (Example Local Codes - Drug#GrowthPromotion) subject: See on this page: Procedure/44aa47fd-8964-5f96-8495-b2bec7f161a8 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: Growth Promotion - Beginning (Example Local Codes - Drug#Growth Promotion - Beginning) value: Pass component code: Growth Promotion - End (Example Local Codes - Drug#Growth Promotion - End) value: Pass
Generated Narrative: Observation Resource Observation "64aa47fd-8964-5f98-6495-b2bec7f161e8" instantiates: See on this page: ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524 status: final code: Growth Promotion (Example Local Codes - Drug#GrowthPromotion) subject: See on this page: Procedure/44aa47fd-8964-5f96-6495-b2bec7f162a8 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: Growth Promotion - Beginning (Example Local Codes - Drug#Growth Promotion - Beginning) value: Pass component code: Growth Promotion - End (Example Local Codes - Drug#Growth Promotion - End) value: Pass
Generated Narrative: Observation Resource Observation "74aa47fd-8964-5f99-7495-b2bec7f161e8" instantiates: See on this page: ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524 status: final code: Growth Promotion (Example Local Codes - Drug#GrowthPromotion) subject: See on this page: Procedure/44aa47fd-8964-5f96-6495-b2bec7f163a8 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: Growth Promotion - Beginning (Example Local Codes - Drug#Growth Promotion - Beginning) value: Pass component code: Growth Promotion - End (Example Local Codes - Drug#Growth Promotion - End) value: Fail
Generated Narrative: Procedure Resource Procedure "44aa47fd-8964-5f96-8495-b2bec7f161a8" identifier: Run 1 status: completed code: Media Challenge Run (Example Local Codes - Drug#MediaChallengeRun) subject: : Drug product
Generated Narrative: Procedure Resource Procedure "44aa47fd-8964-5f96-6495-b2bec7f162a8" identifier: Run 2 status: completed code: Media Challenge Run (Example Local Codes - Drug#MediaChallengeRun) subject: : Drug product
Generated Narrative: Procedure Resource Procedure "44aa47fd-8964-5f96-6495-b2bec7f163a8" identifier: Run 3 status: completed code: Media Challenge Run (Example Local Codes - Drug#MediaChallengeRun) subject: : Drug product
Generated Narrative: Procedure Resource Procedure "44aa47fd-8964-5f96-6495-c2bec7f163a8" status: completed code: Lyophilization Homogeneneity (Example Local Codes - Drug#LyophilizationHomogeneneity) subject: : Drug batch Performers - Actor * Definitions - Reference * #DDLyo1 Generated Narrative: Device #device-nosubject Definitions - Reference * #DDLyo1 Generated Narrative: DeviceDefinition #DDLyo1 identifier: Lyo 1
Generated Narrative: Observation Resource Observation "44aa47fd-8964-5f96-6495-b2bec7f161e7" instantiates: See on this page: ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434 status: final code: Post-filtration Filter Integrity (psig) (Example Local Codes - Drug#Post-filtration Filter Integrity (psig)) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 280 mOsm/kg Components - Code Value[x] * Test Success (Example Local Codes - Drug#test-success) Pass ()
Generated Narrative: Observation Resource Observation "44aa47fd-8964-4f96-6495-b2bec7f161e7" instantiates: See on this page: ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424 status: final code: osmolality (Example Local Codes - Drug#Osmolality "Osmolality") subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 280 mOsm/kg
Generated Narrative: Observation Resource Observation "54aa47fd-8964-4f96-6495-b2bec7f162e7" instantiates: See on this page: ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424 status: final code: osmolality (Example Local Codes - Drug#Osmolality "Osmolality") subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 285 mOsm/kg
Generated Narrative: Observation Resource Observation "54aa48fd-8964-4f96-6495-b2bec7f163e7" instantiates: See on this page: ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424 status: final code: osmolality (Example Local Codes - Drug#Osmolality "Osmolality") subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 290 mOsm/kg
Generated Narrative: Observation Resource Observation "44ba47fd-8964-4f96-6495-b2bec7f161e8" instantiates: See on this page: ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72 status: final code: Residual Moisture (%) (Example Local Codes - Drug#Residual Moisture "Residual Moisture") subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: Residual Moisture - Min (Example Local Codes - Drug#Residual Moisture - Min) value: 3.1 % component code: Residual Moisture - Max (Example Local Codes - Drug#Residual Moisture - Max) value: 3.2 % component code: Number of Samples (Example Local Codes - Drug#SAMP) value: 2
Generated Narrative: Observation Resource Observation "44ba47fd-9964-4f96-6495-b2bec7f161e8" instantiates: See on this page: ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72 status: final code: Residual Moisture (%) (Example Local Codes - Drug#Residual Moisture "Residual Moisture") subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 4.2 % Components - Code Value[x] * Number of Samples (Example Local Codes - Drug#SAMP) 3
Generated Narrative: Observation Resource Observation "44ba47fd-9964-4f96-6496-b2bec7f161e8" instantiates: See on this page: ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72 status: final code: Residual Moisture (%) (Example Local Codes - Drug#Residual Moisture "Residual Moisture") subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 4.4 % Components - Code Value[x] * Number of Samples (Example Local Codes - Drug#SAMP) 3
Generated Narrative: Observation Resource Observation "44ba47fd-8964-4f96-6495-b2bec7f161e7" instantiates: See on this page: ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424 status: final code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak") subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: SE-UHPLC Main Peak - Beginning (Example Local Codes - Drug#SE-UHPLC Main Peak - Beginning) value: 8.0 % component code: SE-UHPLC Main Peak - End (Example Local Codes - Drug#SE-UHPLC Main Peak - End) value: 8.5 %
Generated Narrative: Observation Resource Observation "54ca47fd-8964-4f96-6495-b2bec7f162e7" instantiates: See on this page: ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424 status: final code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak") subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: SE-UHPLC Main Peak - Beginning (Example Local Codes - Drug#SE-UHPLC Main Peak - Beginning) value: 9.0 % component code: SE-UHPLC Main Peak - End (Example Local Codes - Drug#SE-UHPLC Main Peak - End) value: 9.5 %
Generated Narrative: Observation Resource Observation "54da48fd-8964-4f96-6495-b2bec7f163e7" instantiates: See on this page: ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424 status: final code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak") subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: SE-UHPLC Main Peak - Beginning (Example Local Codes - Drug#SE-UHPLC Main Peak - Beginning) value: 10.0 % component code: SE-UHPLC Main Peak - End (Example Local Codes - Drug#SE-UHPLC Main Peak - End) value: 10.5 %
Generated Narrative: Observation Resource Observation "44ba47fd-8964-5f96-6495-b2bec7f161e7" instantiates: See on this page: ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424 status: final code: SE-UHPLC Main Peak (Graph) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak") subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value:
Generated Narrative: Observation Resource Observation "54ba47fd-8964-4f96-6495-b2bec7f161e7" instantiates: See on this page: ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424 status: final code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak") subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 91 %
Generated Narrative: Observation Resource Observation "54ba47fd-8964-4f96-6495-b2bec7f161e8" instantiates: See on this page: ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424 status: final code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak") subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 89 %
Generated Narrative: Observation Resource Observation "54ba47fd-8964-4f96-6495-b2bec7f161e9" instantiates: See on this page: ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424 status: final code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak") subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 92 %
Generated Narrative: Observation Resource Observation "54ba48fd-8964-4f96-6495-b2bec7f161e7" instantiates: See on this page: ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424 status: final code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak") subject: : Product effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: Number of Samples (Example Local Codes - Drug#SAMP) value: 12 component code: SE-UHPLC Main Peak Conclusion (Example Local Codes - Drug#SE-UHPLCMainPeak - Conclusion "SE-UHPLC Main Peak - Conclusion") value: Pass
Generated Narrative: Observation Resource Observation "54bb47fd-8964-4f96-6495-b2bec7f161e7" instantiates: See on this page: ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424 status: final code: SE-UHPLC HMW (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW") subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 88 %
Generated Narrative: Observation Resource Observation "54ba47fd-9964-4f96-6495-b2bec7f161e8" instantiates: See on this page: ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424 status: final code: SE-UHPLC HMW (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW") subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 93 %
Generated Narrative: Observation Resource Observation "54ba47fe-8964-4f96-6495-b2bec7f161e9" instantiates: See on this page: ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424 status: final code: SE-UHPLC HMW (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW") subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 99 %
Generated Narrative: Observation Resource Observation "64ba48fd-8964-4f96-6495-b2bec7f161e7" instantiates: See on this page: ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424 status: final code: SE-UHPLC HMW (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW") subject: : Product effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: Number of Samples (Example Local Codes - Drug#SAMP) value: 9 component code: SE-UHPLC HMW Conclusion (Example Local Codes - Drug#SE-UHPLCHMWPeak - Conclusion "SE-UHPLC HMW Peak - Conclusion") value: Fail
Generated Narrative: Observation Resource Observation "44ba47fd-8964-4f97-6495-b2bec7f161e7" instantiates: See on this page: ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424 status: final code: SE-UHPLC HMW (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW") subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: SE-UHPLC HMW - Beginning (Example Local Codes - Drug#SE-UHPLCHMW - Beginning) value: 7.0 % component code: SE-UHPLC HMW - End (Example Local Codes - Drug#SE-UHPLCHMW - End) value: 7.5 %
Generated Narrative: Observation Resource Observation "54ca47fd-8964-4f98-6495-b2bec7f162e7" instantiates: See on this page: ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424 status: final code: SE-UHPLC HMW (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW") subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: SE-UHPLC HMW - Beginning (Example Local Codes - Drug#SE-UHPLCHMW - Beginning) value: 8.0 % component code: SE-UHPLC HMW - End (Example Local Codes - Drug#SE-UHPLCHMW - End) value: 8.5 %
Generated Narrative: Observation Resource Observation "54da48fd-8964-4f99-6495-b2bec7f163e7" instantiates: See on this page: ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424 status: final code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW") subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: SE-UHPLC HMW - Beginning (Example Local Codes - Drug#SE-UHPLCHMW - Beginning) value: 9.0 % component code: SE-UHPLC HMW - End (Example Local Codes - Drug#SE-UHPLCHMW - End) value: 9.5 %
Generated Narrative: Observation Resource Observation "55aa47fd-9964-5f97-6495-b2bec7f161e8" instantiates: See on this page: ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524 status: final code: Fill Weight (Example Local Codes - Drug#Fill Weight) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: Fill Weight - Minimum (Example Local Codes - Drug#Fill Weight - Minimum) value: 9.90 g component code: Fill Weight - Maximum (Example Local Codes - Drug#Fill Weight - Maximum) value: 9.92 g component code: Fill Weight - Mean (Example Local Codes - Drug#Fill Weight - Mean) value: 9.91 CFU/100 mL
Quality Attribute Justification Analytical Method Quantity Demonstrates that the drug product content is maintained throughout the filling process Protein concentration Purity Demonstrates the product quality is not adversely impacted over the duration of the fill through aggregation and / or oxidation SE-UHPLC Subvisible Particles Quantitatively determines that subvisible particle content is maintained within specification throughout the filling process Light obscuration
Generated Narrative: MedicinalProductDefinition Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" description: Textual description of the product combinedPharmaceuticalDoseForm: Gastro-resistant tablet (standardterms.edqm.eu#10225000) route: Oral use (standardterms.edqm.eu#20053000) name productName: Biocure type: Proprietary (Product Name Type - example#Proprietary) Parts - Part Type * 20mg Strength part (Product Name Part Type#StrengthPart)
Generated Narrative: Ingredient Resource Ingredient "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6" status: active for: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5 role: Active (Ingredient Role#100000072072) substance Codes - Reference * See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "57a9af63-315d-1585-a261-0e337b289390" manufacturer: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c Names - Name * Biocurolol
Generated Narrative: Organization Resource Organization "49d2f0c0-4b28-9271-8aaf-2996a8b9739c" identifier: urn:oid:2.16.840.1.113883.4.82/3003040516 active: true type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#drug-substance-manufacture) name: AAA Molybdenum Products, Inc. Contacts - Address * 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA
Generated Narrative: PlanDefinition Resource PlanDefinition "bf6b038b-1334-3dd4-a552-65c169e2265a" Profile: PlanDefinition - Drug PQ Tag: http://terminology.hl7.org/CodeSystem/v3-ObservationValue Extension - History of Process PQ: This can be text about the history url: http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a title: Process 1.0 type: Workflow Definition (PlanDefinitionType#workflow-definition; Pharmaceutical Plan Type Codes#manufacturing-process "Manufacturing Process") status: active subject: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5 description: Narrative description of manufacturing process (5) goal id goal-control-pH category: Physical Property (Pharmaceutical Test Category Codes#C123456) description: Controls - pH () priority: Critical (Goal Priority - example#critical) Targets - Measure Detail[x] * pH must be in range 6.9 to 7.1 (Example Local Codes - Drug#pH "pH") 6.9-7.1 pH goal id goal-control-water-content category: Physical Property (Pharmaceutical Test Category Codes#C123456) description: Controls - Water Content () priority: Critical (Goal Priority - example#critical) Targets - Measure Detail[x] * Under 2% (Example Local Codes - Drug#WaterContent "Water content") ?-2 goal id goal-control-particle-size category: Physical Property (Pharmaceutical Test Category Codes#C123456) description: Controls - Particle Size () priority: Critical (Goal Priority - example#critical) Targets - Measure Detail[x] * Under 200 microns (Example Local Codes - Drug#particle-size "Particle Size") ?-200 actor Options - TypeReference Role * See on this page: DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d Mixing Vessel (Pharmaceutical Manufacturing Equipment Class Codes#mixing-vessel) actor Options - TypeReference Role * See on this page: DeviceDefinition/82a39a18-91cf-b29d-76c1-a9e8bad9494d Receiving Vessel (Pharmaceutical Manufacturing Equipment Class Codes#receiving-vessel)
Narrative description of manufacturing process (5)
Generated Narrative: DeviceDefinition Resource DeviceDefinition "82a39a18-91cf-a29d-76c1-a9e8bad9494d" DeviceNames - Name Type * Mixing Vessel registered-name Classifications - Type * Mixing Vessel (Device Type - example#mixing-vessel) Properties - Type Value[x] * Capacity (Device Property Codes#Capacity) 1000 litres
Generated Narrative: DeviceDefinition Resource DeviceDefinition "82a39a18-91cf-b29d-76c1-a9e8bad9494d" DeviceNames - Name Type * Receiving Tank registered-name Classifications - Type * Receiving Tank (Device Type - example#receiving-tank) Properties - Type Value[x] * Capacity (Device Property Codes#Capacity) 1200 litres
Generated Narrative: Substance Resource Substance "fc078762-81c5-5656-9744-13c7ad1e595b" Medication Manufacturing Batch url manufacturingDate value: 2019-09-07 url batchQuantity value: 5 kg url batchUtilization value: Development (NCI Thesaurus#C133991) url assignedManufacturer value: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Retest Date PQ: 2022-09-08 Extension - Actual Yield PQ: 4.8 kg identifier: CAT1 instance: true Codes - Reference * See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390
Generated Narrative: Substance Resource Substance "cb31d747-2338-88d5-342c-8e9c097e4dad" Medication Manufacturing Batch url manufacturingDate value: 2019-09-07 url batchQuantity value: 5 kg url batchUtilization value: Development (NCI Thesaurus#C133991) url assignedManufacturer value: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Retest Date PQ: 2022-09-08 Extension - Actual Yield PQ: 4.8 kg identifier: SUB2 instance: true Codes - Reference * See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390
Generated Narrative: Substance Resource Substance "1551f97b-6f6d-825e-1fb3-44b0b090808c" Medication Manufacturing Batch url manufacturingDate value: 2019-09-07 url batchQuantity value: 5 kg url batchUtilization value: Development (NCI Thesaurus#C133991) url assignedManufacturer value: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Retest Date PQ: 2022-09-08 Extension - Actual Yield PQ: 4.8 kg identifier: SUB3 instance: true Codes - Reference * See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390