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
Bundle bundle-product-process-validation-pq-ex3-prod-bio of type collection
Entry 1 - fullUrl = urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f
Resource PlanDefinition:
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; CodeSystem - Plan Type#process-validation "Process Validation")
status: ACTIVE
subject: See above (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 (CodeSystem - Manufacturing Step#FormulationBufferPreparationProcessParameterStep)
action
action
title: Formulation Buffer Preparation Performance Indicator Results
code: Formulation Buffer Preparation Performance Indicator Results (CodeSystem - Manufacturing Step#FormulationBufferPreparationPerformanceIndicatorStep)
action
action
title: Thawing and Formulation Process Parameter Results
code: Thawing and Formulation Process Parameter Resultss (CodeSystem - Manufacturing Step#ThawingandFormulationProcessParameterResultsStep)
action
action
title: Thawing and Formulation Performance Indicator Results
code: Thawing and Formulation Performance Indicator Results (CodeSystem - Manufacturing Step#ThawingandFormulationPerformanceIndicatorResultsStep)
action
action
title: Bioburden Reduction Filtration Process Parameter Results
code: Bioburden Reduction Filtration Process Parameter Results (CodeSystem - Manufacturing Step#BioburdenReductionFiltrationProcessParameterResultsStep)
Actions
Code Definition[x] Test () ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434
action
title: Bioburden Reduction Filtration Performance Indicator Results
code: Bioburden Reduction Filtration Performance Indicator Results (CodeSystem - Manufacturing Step#BioburdenReductionFiltrationPerformanceIndicatorResultsStep)
Actions
Code Definition[x] Test () ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434
Test () ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434
action
title: Media Challenge Hold Times
code: Media Challenge Hold Times (CodeSystem - Manufacturing Step#MediaChallengeHoldTimesStep)
Actions
Code Definition[x] Test () ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434
action
title: Media Challenge Results
code: Media Challenge Results (CodeSystem - Manufacturing Step#MediaChallengeResultsStep)
Actions
Code Definition[x] Test () ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524
Test () ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524
action
title: Filtered Formulated Drug Product Performance Indicator Results
code: Filtered Formulated Drug Product Performance Indicator Results (CodeSystem - Manufacturing Step#FilteredFormulatedDrugProductPerformanceIndicatorResultsStep)
Actions
Code Definition[x] Test () ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424
Test () ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424
Test () ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424
action
title: Fill Weight Summary
code: Fill Weight Summary (CodeSystem - Manufacturing Step#FillWeightSummaryStep)
Actions
Code Definition[x] Test () ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524
action
title: Filling Homogeneity Quality Attributes
code: Filling Homogeneity Quality Attributes (CodeSystem - Manufacturing Step#FillingHomogeneityQualityAttributesStep)
Actions
Code Definition[x] Conclusion () ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424
action
title: Filling Results Summary
code: Filling Results Summary (CodeSystem - Manufacturing Step#FillingResultsSummaryStep)
Actions
Code Definition[x] Test () ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524
Test () ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524
action
title: Statistical Evaluation of Homogeneity Data
code: Statistical Evaluation of Homogeneity Data (CodeSystem - Manufacturing Step#StatisticalEvaluationOfHomogeneityDataStep)
Actions
Code Definition[x] Test () ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534
Test () ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524
action
title: Consistency of the Lyophilization Process
code: Consistency of the Lyophilization Process (CodeSystem - Manufacturing Step#ConsistencyoftheLyophilizationProcessStep)
Actions
Code Definition[x] Test () ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72
Definition () ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bd
action
title: Lyophilization Homogeneity
code: Lyophilization Homogeneity Results (CodeSystem - Manufacturing Step#LyophilizationHomogeneityStep)
Actions
Code Definition[x] Test () ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424
Test () ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424
Entry 2 - fullUrl = urn:uuid:b664977d-799d-a1ce-928a-6def2a9955bd
Resource ActivityDefinition:
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
Entry 3 - fullUrl = urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08
Resource Organization:
Generated Narrative: Organization
Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b08"
name: Testing Lab
Entry 4 - fullUrl = urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd
Resource DiagnosticReport:
Process Validation Report
When For 2020-12 Report Details
Code Value When For Buffer vessel mixing speed (rpm) 205 rpm 2023-01-01 12:00:00+0000 Buffer vessel mixing speed (rpm) 210 rpm 2023-01-01 12:00:00+0000 Buffer vessel mixing speed (rpm) 198 rpm 2023-01-01 12:00:00+0000 Buffer vessel mixing time (min) 51 mins 2023-01-01 12:00:00+0000 Buffer vessel mixing time (min) 49 mins 2023-01-01 12:00:00+0000 Buffer vessel mixing time (min) 52 mins 2023-01-01 12:00:00+0000 pH 6.9 pH 2023-01-01 12:00:00+0000 pH 7.1 pH 2023-01-01 12:00:00+0000 pH 7.2 pH 2023-01-01 12:00:00+0000 osmolality 280 mOsm/kg 2023-01-01 12:00:00+0000 osmolality 285 mOsm/kg 2023-01-01 12:00:00+0000 osmolality 290 mOsm/kg 2023-01-01 12:00:00+0000 Post-filtration Filter Integrity (psig) 280 mOsm/kg 2023-01-01 12:00:00+0000 Hold Time (hr) 1.25 hours 2023-01-01 12:00:00+0000 Hold Time (hr) 1.5 hours 2023-01-01 12:00:00+0000 Hold Time (hr) 1.75 hours 2023-01-01 12:00:00+0000 Bioburden (CFU/ 100 mL) 2023-01-01 12:00:00+0000 Bioburden (CFU/ 100 mL) 2023-01-01 12:00:00+0000 Bioburden (CFU/ 100 mL) 2023-01-01 12:00:00+0000 Growth Promotion 2023-01-01 12:00:00+0000 Growth Promotion 2023-01-01 12:00:00+0000 Growth Promotion 2023-01-01 12:00:00+0000 SE-UHPLC Main Peak (%) 2023-01-01 12:00:00+0000 SE-UHPLC Main Peak (%) 2023-01-01 12:00:00+0000 SE-UHPLC Main Peak (%) 2023-01-01 12:00:00+0000 SE-UHPLC Main Peak (Graph) No display for Attachment 2023-01-01 12:00:00+0000 SE-UHPLC HMW (%) 2023-01-01 12:00:00+0000 SE-UHPLC HMW (%) 2023-01-01 12:00:00+0000 SE-UHPLC Main Peak (%) 2023-01-01 12:00:00+0000 Fill Weight 2023-01-01 12:00:00+0000 Conclusion 2023-01-01 12:00:00+0000 Protein Concentration (mg/mL) 2023-01-01 12:00:00+0000 Polysorbate 80 concentration (% w/v) 2023-01-01 12:00:00+0000 Protein Concentration (mg/mL) 2023-01-01 12:00:00+0000 Residual Moisture (%) 2023-01-01 12:00:00+0000 Residual Moisture (%) 4.2 % 2023-01-01 12:00:00+0000 Residual Moisture (%) 4.4 % 2023-01-01 12:00:00+0000 SE-UHPLC Main Peak (%) 91 % 2023-01-01 12:00:00+0000 SE-UHPLC Main Peak (%) 89 % 2023-01-01 12:00:00+0000 SE-UHPLC Main Peak (%) 92 % 2023-01-01 12:00:00+0000 SE-UHPLC Main Peak (%) 2023-01-01 12:00:00+0000 SE-UHPLC HMW (%) 88 % 2023-01-01 12:00:00+0000 SE-UHPLC HMW (%) 93 % 2023-01-01 12:00:00+0000 SE-UHPLC HMW (%) 99 % 2023-01-01 12:00:00+0000 SE-UHPLC HMW (%) 2023-01-01 12:00:00+0000 The samples have been assessed and the conclusion is...
Entry 5 - fullUrl = urn:uuid:fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Buffer vessel mixing speed (rpm))
QualifiedValues
Range 150-250 rpm
Entry 6 - fullUrl = urn:uuid:fc17b5d5-9fe1-91c2-2d06-47cb5b295e72
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Formulation vessel mixing speed (rpm))
QualifiedValues
Range 150-250 rpm
Entry 7 - fullUrl = urn:uuid:fc17b5d5-9fe1-91c2-2d06-47cb5b295e73
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Buffer vessel mixing time (min))
QualifiedValues
Range 45-55 mins
Entry 8 - fullUrl = urn:uuid:fc27b5d5-9fe1-92c2-2d06-47cb5b295e73
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Formulation vessel mixing time (min))
QualifiedValues
Range 45-55 mins
Entry 9 - fullUrl = urn:uuid:fc27b6d6-9fe2-91c2-2d16-47cb5b295e72
Resource ObservationDefinition:
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 (CodeSystem - Example Local Codes - Drug#Residual Moisture "Residual Moisture")
QualifiedValues
Range ?-7.15 component
code: Residual Moisture - Min (CodeSystem - Example Local Codes - Drug#Residual Moisture - Min)
component
code: Residual Moisture - Max (CodeSystem - Example Local Codes - Drug#Residual Moisture - Max)
component
code: Number of Samples (CodeSystem - Example Local Codes - Drug#SAMP)
Entry 10 - fullUrl = urn:uuid:fc27b5d6-9fe1-91c2-2d16-47cb5b295e72
Resource ObservationDefinition:
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 (CodeSystem - Example Local Codes - Drug#pH)
QualifiedValues
Range 6.55-7.15 pH
Entry 11 - fullUrl = urn:uuid:fc27b5d6-9fe2-91c2-2d16-47cb5b295e72
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Thaw Time "Thaw Time")
QualifiedValues
Range ?-3
Entry 12 - fullUrl = urn:uuid:fc17b5d6-9fe1-91c2-2d16-47cb5b295e72
Resource ObservationDefinition:
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 (CodeSystem - Example Local Codes - Drug#pH)
QualifiedValues
Range 6.95-7.05 pH
Entry 13 - fullUrl = urn:uuid:64525a3c-5034-448a-9c19-938ce1958424
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Osmolality "Osmolality")
QualifiedValues
Range 250-300 mOsm/kg
Entry 14 - fullUrl = urn:uuid:64525a3d-5134-448a-9c19-938ce1958424
Resource ObservationDefinition:
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 (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")
QualifiedValues
Extension Range 85-95 % component
code: SE-UHPLC Main Peak - Conclusion (CodeSystem - Example Local Codes - Drug#SE-UHPLC Main Peak - Conclusion)
QualifiedValues
Extension component
code: Number of Samples (CodeSystem - Example Local Codes - Drug#OVERALLSAMP)
Entry 15 - fullUrl = urn:uuid:64525a3d-5144-448a-9c19-938ce1958424
Resource ObservationDefinition:
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 (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")
QualifiedValues
Extension Range 88-92 % component
code: SE-UHPLC HMW - Conclusion (CodeSystem - Example Local Codes - Drug#SE-UHPLC HMW - Conclusion)
QualifiedValues
Extension component
code: Number of Samples (CodeSystem - Example Local Codes - Drug#OVERALLSAMP)
Entry 16 - fullUrl = urn:uuid:64525a3d-5034-448a-9c19-938ce1958424
Resource ObservationDefinition:
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 (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")
QualifiedValues
Range 5-? %
Entry 17 - fullUrl = urn:uuid:64525a4d-5034-448a-9c19-938ce1958424
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")
Entry 18 - fullUrl = urn:uuid:64525a33-5034-448a-9c19-938ce1958424
Resource ObservationDefinition:
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 (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")
QualifiedValues
Range 7-? %
Entry 19 - fullUrl = urn:uuid:22515a3c-5034-448a-9c19-938ce1958424
Resource ObservationDefinition:
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 (CodeSystem - Example Local Codes - Drug#CONC)
Entry 20 - fullUrl = urn:uuid:22525a3c-5035-448a-9c19-938ce1958424
Resource ObservationDefinition:
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 (CodeSystem - Example Local Codes - Drug#CONC)
Entry 21 - fullUrl = urn:uuid:64515a3c-5034-448a-9c19-938ce1958424
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Osmolality "Osmolality")
QualifiedValues
Range 240-310 mOsm/kg
Entry 22 - fullUrl = urn:uuid:74515a3c-5034-448a-9c19-938ce1958424
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Thawing Temp "Thawing Temp")
QualifiedValues
Range 20-24 °C
Entry 23 - fullUrl = urn:uuid:64515a3c-5134-448a-9c19-939ce1958424
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Conductivity (μS/cm))
QualifiedValues
Range 150-200 μS/cm
Entry 24 - fullUrl = urn:uuid:74515a3c-5134-448a-9c19-939ce1958424
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Conductivity (μS/cm))
QualifiedValues
Range 150-200 μS/cm
Entry 25 - fullUrl = urn:uuid:64515b3c-5134-448a-9c19-939ce1958424
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Bioburden (CFU/ 100 mL))
QualifiedValues
Range 50-150 CFU/ 100 mL
Entry 26 - fullUrl = urn:uuid:64515b3c-5134-448a-9c19-939ce1958524
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Bioburden (CFU/ 100 mL))
QualifiedValues
Range ?-10 component
code: Bioburden - Beginning (CodeSystem - Example Local Codes - Drug#Bioburden - Beginning)
component
code: Bioburden - End (CodeSystem - Example Local Codes - Drug#Bioburden - End)
Entry 27 - fullUrl = urn:uuid:74515b3c-5234-448a-9c19-939ce1958524
Resource ObservationDefinition:
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 (CodeSystem - Example Local Codes - Drug#Polysorbate 80 concentration - Middle - Max)
QualifiedValues
Range 0.5-1.5 % w/v component
code: Polysorbate 80 concentration - Beginning - Min (CodeSystem - Example Local Codes - Drug#Polysorbate 80 concentration - Beginning - Min)
component
code: Polysorbate 80 concentration - Beginning - Max (CodeSystem - Example Local Codes - Drug#Polysorbate 80 concentration - Beginning - Max)
component
code: Polysorbate 80 concentration - Middle - Min (CodeSystem - Example Local Codes - Drug#Polysorbate 80 concentration - Middle - Min)
component
code: Polysorbate 80 concentration - Middle - Max (CodeSystem - Example Local Codes - Drug#Polysorbate 80 concentration - Middle - Max)
component
code: Polysorbate 80 concentration - End - Min (CodeSystem - Example Local Codes - Drug#Polysorbate 80 concentration - End - Min)
component
code: Polysorbate 80 concentration - End - Max (CodeSystem - Example Local Codes - Drug#Polysorbate 80 concentration - End - Max)
Entry 28 - fullUrl = urn:uuid:74515b3c-5134-448a-9c19-939ce1958524
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Protein Concentration (mg/mL))
QualifiedValues
Range 8-10 (mg/mL) component
code: Protein Concentration - Beginning - Min (CodeSystem - Example Local Codes - Drug#Protein Concentration - Beginning - Min)
component
code: Protein Concentration - Beginning - Max (CodeSystem - Example Local Codes - Drug#Protein Concentration - Beginning - Max)
component
code: Protein Concentration - Middle - Min (CodeSystem - Example Local Codes - Drug#Protein Concentration - Middle - Min)
component
code: Protein Concentration - Middle - Max (CodeSystem - Example Local Codes - Drug#Protein Concentration - Middle - Max)
component
code: Protein Concentration - End - Min (CodeSystem - Example Local Codes - Drug#Protein Concentration - End - Min)
component
code: Protein Concentration - End - Max (CodeSystem - Example Local Codes - Drug#Protein Concentration - End - Max)
Entry 29 - fullUrl = urn:uuid:74515b3c-5134-448a-9c19-939ce1958534
Resource ObservationDefinition:
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 (CodeSystem - Example Local Codes - Drug#Protein Concentration Statistics)
QualifiedValues
Range 8-10 (mg/mL) component
code: Protein Concentration - Beginning - Middle - Mean (CodeSystem - Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Mean)
component
code: Protein Concentration - Beginning - End - Mean (CodeSystem - Example Local Codes - Drug#Protein Concentration - Beginning - End - Mean)
component
code: Protein Concentration - Middle - End - Mean (CodeSystem - Example Local Codes - Drug#Protein Concentration - Middle - End - Mean)
component
code: Protein Concentration - Beginning - Middle - Lower (CodeSystem - Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Lower)
component
code: Protein Concentration - Beginning - End - Lower (CodeSystem - Example Local Codes - Drug#Protein Concentration - Beginning - End - Lower)
component
code: Protein Concentration - Middle - End - Lower (CodeSystem - Example Local Codes - Drug#Protein Concentration - Middle - End - Lower)
component
code: Protein Concentration - Beginning - Middle - Higher (CodeSystem - Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Higher)
component
code: Protein Concentration - Beginning - End - Higher (CodeSystem - Example Local Codes - Drug#Protein Concentration - Beginning - End - Higher)
component
code: Protein Concentration - Middle - End - Higher (CodeSystem - Example Local Codes - Drug#Protein Concentration - Middle - End - Higher)
component
code: Protein Concentration - Conclusion (CodeSystem - Example Local Codes - Drug#Protein Concentration - Conclusion)
Entry 30 - fullUrl = urn:uuid:64515b3c-5134-448a-9c19-939ce2958524
Resource ObservationDefinition:
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 (CodeSystem - Example Local Codes - Drug#Fill Weight)
QualifiedValues
Extension Range 95-105 g component
code: Bioburden - Beginning (CodeSystem - Example Local Codes - Drug#Bioburden - Beginning)
component
code: Bioburden - End (CodeSystem - Example Local Codes - Drug#Bioburden - End)
Entry 31 - fullUrl = urn:uuid:64515b3c-5134-448a-9d19-939ce1958524
Resource ObservationDefinition:
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 (CodeSystem - Example Local Codes - Drug#GrowthPromotion)
QualifiedValues
Extension component
code: Growth Promotion - Beginning (CodeSystem - Example Local Codes - Drug#Growth Promotion - Beginning)
component
code: Growth Promotion - End (CodeSystem - Example Local Codes - Drug#Growth Promotion - End)
Entry 32 - fullUrl = urn:uuid:64515b3c-5134-448a-9c19-939ce1958434
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Pre-filtration Bioburden (CFU/ 100 mL))
QualifiedValues
Range ?-150
Entry 33 - fullUrl = urn:uuid:64515b3c-5134-448a-9c19-949ce1958424
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Bacterial Endotoxins (EU/mL))
QualifiedValues
Range 40-120 EU/mL
Entry 34 - fullUrl = urn:uuid:64515b4c-5134-448a-9c19-949ce1958424
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Bacterial Endotoxins (EU/mL))
QualifiedValues
Range 50-110 EU/mL
Entry 35 - fullUrl = urn:uuid:74515b3c-5134-448a-9c19-949ce1958434
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#FiltrationPressure (psig))
QualifiedValues
Range 100-150 psig
Entry 36 - fullUrl = urn:uuid:75515b3c-5134-448a-9c19-949ce1958434
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Post-filtration Filter Integrity (psig))
QualifiedValues
Range 100-? psig Components
Code Test Success (CodeSystem - Example Local Codes - Drug#test-success)
Entry 37 - fullUrl = urn:uuid:75515c3c-5134-448a-9c19-949ce1958434
Resource ObservationDefinition:
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 (CodeSystem - Example Local Codes - Drug#Media Challenge Hold Times)
Entry 38 - fullUrl = urn:uuid:64515b3c-5134-448a-9c19-949ce1958434
Resource ObservationDefinition:
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) (CodeSystem - Example Local Codes - Drug#Polysorbate 80 (% w/v))
QualifiedValues
Range 25-55 % w/v
Entry 39 - fullUrl = urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51
Resource Medication:
Generated Narrative: Medication
Resource Medication "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
code: ()
Batches
Extension LotNumber , , , , , , , , , , , , 999909 Generated Narrative: PackagedProductDefinition #ppd1-nosubject
containedItemQuantity: 20 ml
Entry 40 - fullUrl = urn:uuid:339b69fd-4ab1-a1e9-9ea5-1973ba2f6b51
Resource Medication:
Generated Narrative: Medication
Resource Medication "339b69fd-4ab1-a1e9-9ea5-1973ba2f6b51"
code: ()
Batches
Extension LotNumber , , , , , , , , , , 999910 Generated Narrative: PackagedProductDefinition #ppd1-nosubject
containedItemQuantity: 50 ml
Entry 41 - fullUrl = urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc
Resource Medication:
Generated Narrative: Medication
Resource Medication "a9dfda53-734b-045f-7ae4-94a6281d53bc"
code: ()
Batches
Extension LotNumber , , , , , , , , , , 999911 Generated Narrative: PackagedProductDefinition #ppd1-nosubject
containedItemQuantity: 20 ml
Entry 42 - fullUrl = urn:uuid:a9dfda53-734b-045f-7ae5-94a6281d53bc
Resource Medication:
Generated Narrative: Medication
Resource Medication "a9dfda53-734b-045f-7ae5-94a6281d53bc"
code: ()
Batches
Extension LotNumber , , , , , , , , , , 999912 Generated Narrative: PackagedProductDefinition #ppd1-nosubject
containedItemQuantity: 50 ml
Entry 43 - fullUrl = urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06
Resource Medication:
Generated Narrative: Medication
Resource Medication "c6f5fadd-62e6-3a01-93d9-b3b182f67d06"
code: ()
Batches
Extension LotNumber , , , , , , , , , , 999913 Generated Narrative: PackagedProductDefinition #ppd1-nosubject
containedItemQuantity: 20 ml
Entry 44 - fullUrl = urn:uuid:c6f5fadd-62e6-3a11-93d9-b3b182f67d06
Resource Medication:
Generated Narrative: Medication
Resource Medication "c6f5fadd-62e6-3a11-93d9-b3b182f67d06"
code: ()
Batches
Extension LotNumber , , , , , , , , , , 999914 Generated Narrative: PackagedProductDefinition #ppd1-nosubject
containedItemQuantity: 50 ml
Entry 45 - fullUrl = urn:uuid:0102bca4-46c1-a6bf-1025-cd403fee710a
Resource Organization:
Generated Narrative: Organization
Resource Organization "0102bca4-46c1-a6bf-1025-cd403fee710a"
identifier: id: 3010027650
name: AAA Pharmaceutical, Inc.
Contacts
Address 681 Main Street Lumberton New Jersey 08048 USA
Entry 46 - fullUrl = urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b07
Resource Organization:
Generated Narrative: Organization
Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b07"
name: MySite
Entry 47 - fullUrl = urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56948a-2a39-6609-1c01-4d197ea57a33"
instantiates: See above (ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72)
status: FINAL
code: Buffer vessel mixing speed (rpm) (CodeSystem - Example Local Codes - Drug#Buffer vessel mixing speed (rpm))
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 205 rpm
Entry 48 - fullUrl = urn:uuid:9c56948a-3a39-6609-1c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56948a-3a39-6609-1c01-4d197ea57a33"
instantiates: See above (ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72)
status: FINAL
code: Buffer vessel mixing speed (rpm) (CodeSystem - Example Local Codes - Drug#Buffer vessel mixing speed (rpm))
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 210 rpm
Entry 49 - fullUrl = urn:uuid:9c56948a-4a39-6609-1c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56948a-4a39-6609-1c01-4d197ea57a33"
instantiates: See above (ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72)
status: FINAL
code: Buffer vessel mixing speed (rpm) (CodeSystem - Example Local Codes - Drug#Buffer vessel mixing speed (rpm))
subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 198 rpm
Entry 50 - fullUrl = urn:uuid:9c56948a-2a39-6609-2c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56948a-2a39-6609-2c01-4d197ea57a33"
instantiates: See above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73)
status: FINAL
code: Buffer vessel mixing time (min) (CodeSystem - Example Local Codes - Drug#Buffer vessel mixing time (min))
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 51 mins
Entry 51 - fullUrl = urn:uuid:9c56948a-3a39-6609-2c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56948a-3a39-6609-2c01-4d197ea57a33"
instantiates: See above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73)
status: FINAL
code: Buffer vessel mixing time (min) (CodeSystem - Example Local Codes - Drug#Buffer vessel mixing time (min))
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 49 mins
Entry 52 - fullUrl = urn:uuid:9c56948a-4a39-6609-3c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56948a-4a39-6609-3c01-4d197ea57a33"
instantiates: See above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73)
status: FINAL
code: Buffer vessel mixing time (min) (CodeSystem - Example Local Codes - Drug#Buffer vessel mixing time (min))
subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 52 mins
Entry 53 - fullUrl = urn:uuid:44aa47fd-8964-4f96-6495-b2bec7f160e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "44aa47fd-8964-4f96-6495-b2bec7f160e7"
instantiates: See above (ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72)
status: FINAL
code: pH (CodeSystem - Example Local Codes - Drug#pH)
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 6.9 pH
Entry 54 - fullUrl = urn:uuid:54aa47fd-8964-4f96-6495-b2bec7f160e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "54aa47fd-8964-4f96-6495-b2bec7f160e7"
instantiates: See above (ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72)
status: FINAL
code: pH (CodeSystem - Example Local Codes - Drug#pH)
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 7.1 pH
Entry 55 - fullUrl = urn:uuid:54aa48fd-8964-4f96-6495-b2bec7f160e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "54aa48fd-8964-4f96-6495-b2bec7f160e7"
instantiates: See above (ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72)
status: FINAL
code: pH (CodeSystem - Example Local Codes - Drug#pH)
subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 7.2 pH
Entry 56 - fullUrl = urn:uuid:44aa47fd-9964-5f96-6495-b2bec7f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "44aa47fd-9964-5f96-6495-b2bec7f161e8"
instantiates: See above (ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434)
status: FINAL
code: Hold Time (hr) (CodeSystem - Example Local Codes - Drug#Hold Time "Hold Time")
subject: See above (Procedure/44aa47fd-8964-5f96-8495-b2bec7f161a8)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 1.25 hours
Entry 57 - fullUrl = urn:uuid:44aa47fd-8964-5f96-6495-b2bec7f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "44aa47fd-8964-5f96-6495-b2bec7f161e8"
instantiates: See above (ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434)
status: FINAL
code: Hold Time (hr) (CodeSystem - Example Local Codes - Drug#Hold Time "Hold Time")
subject: See above (Procedure/44aa47fd-8964-5f96-6495-b2bec7f162a8)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 1.5 hours
Entry 58 - fullUrl = urn:uuid:44aa47fd-8964-5f96-7495-b2bec7f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "44aa47fd-8964-5f96-7495-b2bec7f161e8"
instantiates: See above (ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434)
status: FINAL
code: Hold Time (hr) (CodeSystem - Example Local Codes - Drug#Hold Time "Hold Time")
subject: See above (Procedure/44aa47fd-8964-5f96-6495-b2bec7f163a8)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 1.75 hours
Entry 59 - fullUrl = urn:uuid:44aa47fd-9964-5f97-6495-b2bec7f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "44aa47fd-9964-5f97-6495-b2bec7f161e8"
instantiates: See above (ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524)
status: FINAL
code: Bioburden (CFU/ 100 mL) (CodeSystem - Example Local Codes - Drug#Bioburden (CFU/ 100 mL))
subject: See above (Procedure/44aa47fd-8964-5f96-8495-b2bec7f161a8)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: Bioburden - Beginning (CodeSystem - Example Local Codes - Drug#Bioburden - Beginning)
value: 8.0 CFU/100 mL
component
code: Bioburden - End (CodeSystem - Example Local Codes - Drug#Bioburden - End)
value: 9.0 CFU/100 mL
Entry 60 - fullUrl = urn:uuid:44aa47fd-8964-5f98-6495-b2bec7f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "44aa47fd-8964-5f98-6495-b2bec7f161e8"
instantiates: See above (ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524)
status: FINAL
code: Bioburden (CFU/ 100 mL) (CodeSystem - Example Local Codes - Drug#Bioburden (CFU/ 100 mL))
subject: See above (Procedure/44aa47fd-8964-5f96-6495-b2bec7f162a8)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: Bioburden - Beginning (CodeSystem - Example Local Codes - Drug#Bioburden - Beginning)
value: 8.5 CFU/100 mL
component
code: Bioburden - End (CodeSystem - Example Local Codes - Drug#Bioburden - End)
value: 8.6 CFU/100 mL
Entry 61 - fullUrl = urn:uuid:44aa47fd-8964-5f99-7495-b2bec7f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "44aa47fd-8964-5f99-7495-b2bec7f161e8"
instantiates: See above (ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524)
status: FINAL
code: Bioburden (CFU/ 100 mL) (CodeSystem - Example Local Codes - Drug#Bioburden (CFU/ 100 mL))
subject: See above (Procedure/44aa47fd-8964-5f96-6495-b2bec7f163a8)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: Bioburden - Beginning (CodeSystem - Example Local Codes - Drug#Bioburden - Beginning)
value: 9.5 CFU/100 mL
component
code: Bioburden - End (CodeSystem - Example Local Codes - Drug#Bioburden - End)
value: 10.1 CFU/100 mL
Entry 62 - fullUrl = urn:uuid:54aa47fd-9965-5f97-6495-b2bec8f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "54aa47fd-9965-5f97-6495-b2bec8f161e8"
instantiates: See above (ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534)
status: FINAL
code: Protein Concentration (mg/mL) (CodeSystem - Example Local Codes - Drug#Protein Concentration (mg/mL))
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: Protein Concentration - Beginning - Middle - Mean (CodeSystem - Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Mean)
value: 8.0 mg/mL
component
code: Protein Concentration - Beginning - End - Mean (CodeSystem - Example Local Codes - Drug#Protein Concentration - Beginning - End - Mean)
value: 8.05 mg/mL
component
code: Protein Concentration - Middle - End - Mean (CodeSystem - Example Local Codes - Drug#Protein Concentration - Middle - End - Mean)
value: 8.10 mg/mL
component
code: Protein Concentration - Beginning - Middle - Lower (CodeSystem - Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Lower)
value: 8.15 mg/mL
component
code: Protein Concentration - Beginning - End - Lower (CodeSystem - Example Local Codes - Drug#Protein Concentration - Beginning - End - Lower)
value: 8.2 mg/mL
component
code: Protein Concentration - Middle - End - Lower (CodeSystem - Example Local Codes - Drug#Protein Concentration - Middle - End - Lower)
value: 8.25 mg/mL
component
code: Protein Concentration - Beginning - Middle - Higher (CodeSystem - Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Higher)
value: 8.45 mg/mL
component
code: Protein Concentration - Beginning - End - Higher (CodeSystem - Example Local Codes - Drug#Protein Concentration - Beginning - End - Higher)
value: 8.3 mg/mL
component
code: Protein Concentration - Middle - End - Higher (CodeSystem - Example Local Codes - Drug#Protein Concentration - Middle - End - Higher)
value: 8.35 mg/mL
component
code: Protein Concentration - Conclusion (CodeSystem - Example Local Codes - Drug#Protein Concentration - Conclusion)
value: Pass
Entry 63 - fullUrl = urn:uuid:54aa47fd-9964-5f97-6495-b2bec8f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "54aa47fd-9964-5f97-6495-b2bec8f161e8"
instantiates: See above (ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524)
status: FINAL
code: Protein Concentration (mg/mL) (CodeSystem - Example Local Codes - Drug#Protein Concentration (mg/mL))
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: Protein Concentration - Beginning - Min (CodeSystem - Example Local Codes - Drug#Protein Concentration - Beginning - Min)
value: 8.00 mg/mL
component
code: Protein Concentration - Beginning - Max (CodeSystem - Example Local Codes - Drug#Protein Concentration - Beginning - Max)
value: 8.05 mg/mL
component
code: Protein Concentration - Middle - Min (CodeSystem - Example Local Codes - Drug#Protein Concentration - Middle - Min)
value: 8.10 mg/mL
component
code: Protein Concentration - Middle - Max (CodeSystem - Example Local Codes - Drug#Protein Concentration - Middle - Max)
value: 8.15 mg/mL
component
code: Protein Concentration - End - Min (CodeSystem - Example Local Codes - Drug#Protein Concentration - End - Min)
value: 8.2 mg/mL
component
code: Protein Concentration - End - Max (CodeSystem - Example Local Codes - Drug#Protein Concentration - End - Max)
value: 8.25 mg/mL
Entry 64 - fullUrl = urn:uuid:54aa47fd-9964-5f97-6495-b2bec8f162e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "54aa47fd-9964-5f97-6495-b2bec8f162e8"
instantiates: See above (ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524)
status: FINAL
code: Polysorbate 80 concentration (% w/v) (CodeSystem - Example Local Codes - Drug#Polysorbate 80 concentration (% w/v))
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: Polysorbate 80 concentration - Beginning - Min (CodeSystem - Example Local Codes - Drug#Polysorbate 80 concentration - Beginning - Min)
value: 1.0 % w/v
component
code: Polysorbate 80 concentration - Beginning - Max (CodeSystem - Example Local Codes - Drug#Polysorbate 80 concentration - Beginning - Max)
value: 1.05 % w/v
component
code: Polysorbate 80 concentration - Middle - Min (CodeSystem - Example Local Codes - Drug#Polysorbate 80 concentration - Middle - Min)
value: 1.10 % w/v
component
code: Polysorbate 80 concentration - Middle - Max (CodeSystem - Example Local Codes - Drug#Polysorbate 80 concentration - Middle - Max)
value: 1.15 % w/v
component
code: Polysorbate 80 concentration - End - Min (CodeSystem - Example Local Codes - Drug#Polysorbate 80 concentration - End - Min)
value: 1.2 % w/v
component
code: Polysorbate 80 concentration - End - Max (CodeSystem - Example Local Codes - Drug#Polysorbate 80 concentration - End - Max)
value: 1.25 % w/v
Entry 65 - fullUrl = urn:uuid:54aa47fd-9964-5f97-6495-b2bec7f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "54aa47fd-9964-5f97-6495-b2bec7f161e8"
instantiates: See above (ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524)
status: FINAL
code: Growth Promotion (CodeSystem - Example Local Codes - Drug#GrowthPromotion)
subject: See above (Procedure/44aa47fd-8964-5f96-8495-b2bec7f161a8)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: Growth Promotion - Beginning (CodeSystem - Example Local Codes - Drug#Growth Promotion - Beginning)
value: Pass
component
code: Growth Promotion - End (CodeSystem - Example Local Codes - Drug#Growth Promotion - End)
value: Pass
Entry 66 - fullUrl = urn:uuid:64aa47fd-8964-5f98-6495-b2bec7f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "64aa47fd-8964-5f98-6495-b2bec7f161e8"
instantiates: See above (ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524)
status: FINAL
code: Growth Promotion (CodeSystem - Example Local Codes - Drug#GrowthPromotion)
subject: See above (Procedure/44aa47fd-8964-5f96-6495-b2bec7f162a8)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: Growth Promotion - Beginning (CodeSystem - Example Local Codes - Drug#Growth Promotion - Beginning)
value: Pass
component
code: Growth Promotion - End (CodeSystem - Example Local Codes - Drug#Growth Promotion - End)
value: Pass
Entry 67 - fullUrl = urn:uuid:74aa47fd-8964-5f99-7495-b2bec7f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "74aa47fd-8964-5f99-7495-b2bec7f161e8"
instantiates: See above (ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524)
status: FINAL
code: Growth Promotion (CodeSystem - Example Local Codes - Drug#GrowthPromotion)
subject: See above (Procedure/44aa47fd-8964-5f96-6495-b2bec7f163a8)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: Growth Promotion - Beginning (CodeSystem - Example Local Codes - Drug#Growth Promotion - Beginning)
value: Pass
component
code: Growth Promotion - End (CodeSystem - Example Local Codes - Drug#Growth Promotion - End)
value: Fail
Entry 68 - fullUrl = urn:uuid:44aa47fd-8964-5f96-8495-b2bec7f161a8
Resource Procedure:
Generated Narrative: Procedure
Resource Procedure "44aa47fd-8964-5f96-8495-b2bec7f161a8"
identifier: id: Run 1
status: COMPLETED
code: Media Challenge Run (CodeSystem - Example Local Codes - Drug#MediaChallengeRun)
subject: : Drug product
Entry 69 - fullUrl = urn:uuid:44aa47fd-8964-5f96-6495-b2bec7f162a8
Resource Procedure:
Generated Narrative: Procedure
Resource Procedure "44aa47fd-8964-5f96-6495-b2bec7f162a8"
identifier: id: Run 2
status: COMPLETED
code: Media Challenge Run (CodeSystem - Example Local Codes - Drug#MediaChallengeRun)
subject: : Drug product
Entry 70 - fullUrl = urn:uuid:44aa47fd-8964-5f96-6495-b2bec7f163a8
Resource Procedure:
Generated Narrative: Procedure
Resource Procedure "44aa47fd-8964-5f96-6495-b2bec7f163a8"
identifier: id: Run 3
status: COMPLETED
code: Media Challenge Run (CodeSystem - Example Local Codes - Drug#MediaChallengeRun)
subject: : Drug product
Entry 71 - fullUrl = urn:uuid:44aa47fd-8964-5f96-6495-c2bec7f163a8
Resource Procedure:
Generated Narrative: Procedure
Resource Procedure "44aa47fd-8964-5f96-6495-c2bec7f163a8"
status: COMPLETED
code: Lyophilization Homogeneneity (CodeSystem - 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: id: Lyo 1
Entry 72 - fullUrl = urn:uuid:44aa47fd-8964-5f96-6495-b2bec7f161e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "44aa47fd-8964-5f96-6495-b2bec7f161e7"
instantiates: See above (ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434)
status: FINAL
code: Post-filtration Filter Integrity (psig) (CodeSystem - Example Local Codes - Drug#Post-filtration Filter Integrity (psig))
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 280 mOsm/kg
Components
Code Value[x] Test Success (CodeSystem - Example Local Codes - Drug#test-success) Pass ()
Entry 73 - fullUrl = urn:uuid:44aa47fd-8964-4f96-6495-b2bec7f161e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "44aa47fd-8964-4f96-6495-b2bec7f161e7"
instantiates: See above (ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424)
status: FINAL
code: osmolality (CodeSystem - Example Local Codes - Drug#Osmolality "Osmolality")
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 280 mOsm/kg
Entry 74 - fullUrl = urn:uuid:54aa47fd-8964-4f96-6495-b2bec7f162e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "54aa47fd-8964-4f96-6495-b2bec7f162e7"
instantiates: See above (ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424)
status: FINAL
code: osmolality (CodeSystem - Example Local Codes - Drug#Osmolality "Osmolality")
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 285 mOsm/kg
Entry 75 - fullUrl = urn:uuid:54aa48fd-8964-4f96-6495-b2bec7f163e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "54aa48fd-8964-4f96-6495-b2bec7f163e7"
instantiates: See above (ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424)
status: FINAL
code: osmolality (CodeSystem - Example Local Codes - Drug#Osmolality "Osmolality")
subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 290 mOsm/kg
Entry 76 - fullUrl = urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "44ba47fd-8964-4f96-6495-b2bec7f161e8"
instantiates: See above (ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72)
status: FINAL
code: Residual Moisture (%) (CodeSystem - Example Local Codes - Drug#Residual Moisture "Residual Moisture")
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: Residual Moisture - Min (CodeSystem - Example Local Codes - Drug#Residual Moisture - Min)
value: 3.1 %
component
code: Residual Moisture - Max (CodeSystem - Example Local Codes - Drug#Residual Moisture - Max)
value: 3.2 %
component
code: Number of Samples (CodeSystem - Example Local Codes - Drug#SAMP)
value: 2
Entry 77 - fullUrl = urn:uuid:44ba47fd-9964-4f96-6495-b2bec7f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "44ba47fd-9964-4f96-6495-b2bec7f161e8"
instantiates: See above (ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72)
status: FINAL
code: Residual Moisture (%) (CodeSystem - Example Local Codes - Drug#Residual Moisture "Residual Moisture")
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 4.2 %
Components
Code Value[x] Number of Samples (CodeSystem - Example Local Codes - Drug#SAMP) 3
Entry 78 - fullUrl = urn:uuid:44ba47fd-9964-4f96-6496-b2bec7f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "44ba47fd-9964-4f96-6496-b2bec7f161e8"
instantiates: See above (ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72)
status: FINAL
code: Residual Moisture (%) (CodeSystem - Example Local Codes - Drug#Residual Moisture "Residual Moisture")
subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 4.4 %
Components
Code Value[x] Number of Samples (CodeSystem - Example Local Codes - Drug#SAMP) 3
Entry 79 - fullUrl = urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "44ba47fd-8964-4f96-6495-b2bec7f161e7"
instantiates: See above (ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC Main Peak (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: SE-UHPLC Main Peak - Beginning (CodeSystem - Example Local Codes - Drug#SE-UHPLC Main Peak - Beginning)
value: 8.0 %
component
code: SE-UHPLC Main Peak - End (CodeSystem - Example Local Codes - Drug#SE-UHPLC Main Peak - End)
value: 8.5 %
Entry 80 - fullUrl = urn:uuid:54ca47fd-8964-4f96-6495-b2bec7f162e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "54ca47fd-8964-4f96-6495-b2bec7f162e7"
instantiates: See above (ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC Main Peak (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: SE-UHPLC Main Peak - Beginning (CodeSystem - Example Local Codes - Drug#SE-UHPLC Main Peak - Beginning)
value: 9.0 %
component
code: SE-UHPLC Main Peak - End (CodeSystem - Example Local Codes - Drug#SE-UHPLC Main Peak - End)
value: 9.5 %
Entry 81 - fullUrl = urn:uuid:54da48fd-8964-4f96-6495-b2bec7f163e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "54da48fd-8964-4f96-6495-b2bec7f163e7"
instantiates: See above (ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC Main Peak (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")
subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: SE-UHPLC Main Peak - Beginning (CodeSystem - Example Local Codes - Drug#SE-UHPLC Main Peak - Beginning)
value: 10.0 %
component
code: SE-UHPLC Main Peak - End (CodeSystem - Example Local Codes - Drug#SE-UHPLC Main Peak - End)
value: 10.5 %
Entry 82 - fullUrl = urn:uuid:44ba47fd-8964-5f96-6495-b2bec7f161e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "44ba47fd-8964-5f96-6495-b2bec7f161e7"
instantiates: See above (ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC Main Peak (Graph) (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value:
Entry 83 - fullUrl = urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "54ba47fd-8964-4f96-6495-b2bec7f161e7"
instantiates: See above (ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC Main Peak (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 91 %
Entry 84 - fullUrl = urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "54ba47fd-8964-4f96-6495-b2bec7f161e8"
instantiates: See above (ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC Main Peak (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 89 %
Entry 85 - fullUrl = urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e9
Resource Observation:
Generated Narrative: Observation
Resource Observation "54ba47fd-8964-4f96-6495-b2bec7f161e9"
instantiates: See above (ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC Main Peak (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")
subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 92 %
Entry 86 - fullUrl = urn:uuid:54ba48fd-8964-4f96-6495-b2bec7f161e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "54ba48fd-8964-4f96-6495-b2bec7f161e7"
instantiates: See above (ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC Main Peak (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")
subject: : Product
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: Number of Samples (CodeSystem - Example Local Codes - Drug#SAMP)
value: 12
component
code: SE-UHPLC Main Peak Conclusion (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak - Conclusion "SE-UHPLC Main Peak - Conclusion")
value: Pass
Entry 87 - fullUrl = urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "54bb47fd-8964-4f96-6495-b2bec7f161e7"
instantiates: See above (ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC HMW (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 88 %
Entry 88 - fullUrl = urn:uuid:54ba47fd-9964-4f96-6495-b2bec7f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "54ba47fd-9964-4f96-6495-b2bec7f161e8"
instantiates: See above (ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC HMW (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 93 %
Entry 89 - fullUrl = urn:uuid:54ba47fe-8964-4f96-6495-b2bec7f161e9
Resource Observation:
Generated Narrative: Observation
Resource Observation "54ba47fe-8964-4f96-6495-b2bec7f161e9"
instantiates: See above (ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC HMW (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")
subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 99 %
Entry 90 - fullUrl = urn:uuid:64ba48fd-8964-4f96-6495-b2bec7f161e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "64ba48fd-8964-4f96-6495-b2bec7f161e7"
instantiates: See above (ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC HMW (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")
subject: : Product
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: Number of Samples (CodeSystem - Example Local Codes - Drug#SAMP)
value: 9
component
code: SE-UHPLC HMW Conclusion (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMWPeak - Conclusion "SE-UHPLC HMW Peak - Conclusion")
value: Fail
Entry 91 - fullUrl = urn:uuid:44ba47fd-8964-4f97-6495-b2bec7f161e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "44ba47fd-8964-4f97-6495-b2bec7f161e7"
instantiates: See above (ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC HMW (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: SE-UHPLC HMW - Beginning (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW - Beginning)
value: 7.0 %
component
code: SE-UHPLC HMW - End (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW - End)
value: 7.5 %
Entry 92 - fullUrl = urn:uuid:54ca47fd-8964-4f98-6495-b2bec7f162e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "54ca47fd-8964-4f98-6495-b2bec7f162e7"
instantiates: See above (ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC HMW (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: SE-UHPLC HMW - Beginning (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW - Beginning)
value: 8.0 %
component
code: SE-UHPLC HMW - End (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW - End)
value: 8.5 %
Entry 93 - fullUrl = urn:uuid:54da48fd-8964-4f99-6495-b2bec7f163e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "54da48fd-8964-4f99-6495-b2bec7f163e7"
instantiates: See above (ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC Main Peak (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")
subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: SE-UHPLC HMW - Beginning (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW - Beginning)
value: 9.0 %
component
code: SE-UHPLC HMW - End (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW - End)
value: 9.5 %
Entry 94 - fullUrl = urn:uuid:55aa47fd-9964-5f97-6495-b2bec7f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "55aa47fd-9964-5f97-6495-b2bec7f161e8"
instantiates: See above (ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524)
status: FINAL
code: Fill Weight (CodeSystem - Example Local Codes - Drug#Fill Weight)
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: Fill Weight - Minimum (CodeSystem - Example Local Codes - Drug#Fill Weight - Minimum)
value: 9.90 g
component
code: Fill Weight - Maximum (CodeSystem - Example Local Codes - Drug#Fill Weight - Maximum)
value: 9.92 g
component
code: Fill Weight - Mean (CodeSystem - Example Local Codes - Drug#Fill Weight - Mean)
value: 9.91 CFU/100 mL
Entry 95 - fullUrl = urn:uuid:45aa47fd-8964-4f96-6495-b2bec7f160f7
Resource Observation:
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
Entry 96 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
Resource MedicinalProductDefinition:
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 (CodeSystem - Product Name Type#Proprietary)
Parts
Part Type 20mg Strength part (Product Name Part Type#StrengthPart)
Entry 97 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6
Resource Ingredient:
Generated Narrative: Ingredient
Resource Ingredient "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6"
status: ACTIVE
for: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)
role: Active (Ingredient Role#100000072072)
substance
Codes
Reference See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)
Entry 98 - fullUrl = urn:uuid:57a9af63-315d-1585-a261-0e337b289390
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "57a9af63-315d-1585-a261-0e337b289390"
manufacturer: See above (Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c)
Names
Name Biocurolol
Entry 99 - fullUrl = urn:uuid:49d2f0c0-4b28-9271-8aaf-2996a8b9739c
Resource Organization:
Generated Narrative: Organization
Resource Organization "49d2f0c0-4b28-9271-8aaf-2996a8b9739c"
identifier: id: 3003040516
name: AAA Molybdenum Products, Inc.
Contacts
Address 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA
Entry 100 - fullUrl = urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a
Resource PlanDefinition:
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; CodeSystem - Plan Type#manufacturing-process "Manufacturing Process")
status: ACTIVE
subject: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)
description: Narrative description of manufacturing process (5)
goal
id
goal-control-pHcategory: Physical Property (CodeSystem - Test Category#C123456)
description: Controls - pH ()
priority: Critical (CodeSystem - Goal Priority#critical)
Targets
Measure Detail[x] pH must be in range 6.9 to 7.1 (CodeSystem - Example Local Codes - Drug#pH "pH") 6.9-7.1 pH goal
id
goal-control-water-contentcategory: Physical Property (CodeSystem - Test Category#C123456)
description: Controls - Water Content ()
priority: Critical (CodeSystem - Goal Priority#critical)
Targets
Measure Detail[x] Under 2% (CodeSystem - Example Local Codes - Drug#WaterContent "Water content") ?-2 goal
id
goal-control-particle-sizecategory: Physical Property (CodeSystem - Test Category#C123456)
description: Controls - Particle Size ()
priority: Critical (CodeSystem - Goal Priority#critical)
Targets
Measure Detail[x] Under 200 microns (CodeSystem - Example Local Codes - Drug#particle-size "Particle Size") ?-200 actor
Options
TypeReference Role See above (DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d) Mixing Vessel (CodeSystem - Equipment Class#mixing-vessel) actor
Options
TypeReference Role See above (DeviceDefinition/82a39a18-91cf-b29d-76c1-a9e8bad9494d) Receiving Vessel (CodeSystem - Equipment Class#receiving-vessel)
Entry 101 - fullUrl = urn:uuid:82a39a18-91cf-a29d-76c1-a9e8bad9494d
Resource DeviceDefinition:
Generated Narrative: DeviceDefinition
Resource DeviceDefinition "82a39a18-91cf-a29d-76c1-a9e8bad9494d"
DeviceNames
Name Type Mixing Vessel REGISTEREDNAME Classifications
Type Mixing Vessel (CodeSystem - Device Type#mixing-vessel) Properties
Type Value[x] Capacity (CodeSystem - Device Property#Capacity) 1000 litres
Entry 102 - fullUrl = urn:uuid:82a39a18-91cf-b29d-76c1-a9e8bad9494d
Resource DeviceDefinition:
Generated Narrative: DeviceDefinition
Resource DeviceDefinition "82a39a18-91cf-b29d-76c1-a9e8bad9494d"
DeviceNames
Name Type Receiving Tank REGISTEREDNAME Classifications
Type Receiving Tank (CodeSystem - Device Type#receiving-tank) Properties
Type Value[x] Capacity (CodeSystem - Device Property#Capacity) 1200 litres
Entry 103 - fullUrl = urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b
Resource Substance:
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 above (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: id: CAT1
instance: true
Codes
Reference See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)
Entry 104 - fullUrl = urn:uuid:cb31d747-2338-88d5-342c-8e9c097e4dad
Resource Substance:
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 above (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: id: SUB2
instance: true
Codes
Reference See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)
Entry 105 - fullUrl = urn:uuid:1551f97b-6f6d-825e-1fb3-44b0b090808c
Resource Substance:
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 above (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: id: SUB3
instance: true
Codes
Reference See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)