Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot International flag

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Example Bundle: Example: Bundle - Process Validation, biologic product

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

-CodeDefinition[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

-CodeDefinition[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

-CodeDefinition[x]
*Test ()ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434

action

title: Media Challenge Results

code: Media Challenge Results (CodeSystem - Manufacturing Step#MediaChallengeResultsStep)

Actions

-CodeDefinition[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

-CodeDefinition[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

-CodeDefinition[x]
*Test ()ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524

action

title: Filling Homogeneity Quality Attributes

code: Filling Homogeneity Quality Attributes (CodeSystem - Manufacturing Step#FillingHomogeneityQualityAttributesStep)

Actions

-CodeDefinition[x]
*Conclusion ()ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424

action

title: Filling Results Summary

code: Filling Results Summary (CodeSystem - Manufacturing Step#FillingResultsSummaryStep)

Actions

-CodeDefinition[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

-CodeDefinition[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

-CodeDefinition[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

-CodeDefinition[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 For2020-12

Report Details

CodeValueWhen For
Buffer vessel mixing speed (rpm)205 rpm2023-01-01 12:00:00+0000
Buffer vessel mixing speed (rpm)210 rpm2023-01-01 12:00:00+0000
Buffer vessel mixing speed (rpm)198 rpm2023-01-01 12:00:00+0000
Buffer vessel mixing time (min)51 mins2023-01-01 12:00:00+0000
Buffer vessel mixing time (min)49 mins2023-01-01 12:00:00+0000
Buffer vessel mixing time (min)52 mins2023-01-01 12:00:00+0000
pH6.9 pH2023-01-01 12:00:00+0000
pH7.1 pH2023-01-01 12:00:00+0000
pH7.2 pH2023-01-01 12:00:00+0000
osmolality280 mOsm/kg2023-01-01 12:00:00+0000
osmolality285 mOsm/kg2023-01-01 12:00:00+0000
osmolality290 mOsm/kg2023-01-01 12:00:00+0000
Post-filtration Filter Integrity (psig)280 mOsm/kg2023-01-01 12:00:00+0000
Hold Time (hr)1.25 hours2023-01-01 12:00:00+0000
Hold Time (hr)1.5 hours2023-01-01 12:00:00+0000
Hold Time (hr)1.75 hours2023-01-01 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 Promotion2023-01-01 12:00:00+0000
Growth Promotion2023-01-01 12:00:00+0000
Growth Promotion2023-01-01 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 Attachment2023-01-01 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 Weight2023-01-01 12:00:00+0000
Conclusion2023-01-01 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

-ExtensionRange
*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

-ExtensionRange
*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

-ExtensionRange
*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

-ExtensionLotNumber
*, , , , , , , , , , , , 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

-ExtensionLotNumber
*, , , , , , , , , , 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

-ExtensionLotNumber
*, , , , , , , , , , 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

-ExtensionLotNumber
*, , , , , , , , , , 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

-ExtensionLotNumber
*, , , , , , , , , , 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

-ExtensionLotNumber
*, , , , , , , , , , 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: urn:oid:2.16.840.1.113883.4.82/3010027650

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: 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: 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: 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: 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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-PartType
*20mgStrength 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: urn:oid:2.16.840.1.113883.4.82/3003040516

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-pH

category: Physical Property (CodeSystem - Test Category#C123456)

description: Controls - pH ()

priority: Critical (CodeSystem - Goal Priority#critical)

Targets

-MeasureDetail[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-content

category: Physical Property (CodeSystem - Test Category#C123456)

description: Controls - Water Content ()

priority: Critical (CodeSystem - Goal Priority#critical)

Targets

-MeasureDetail[x]
*Under 2% (CodeSystem - Example Local Codes - Drug#WaterContent "Water content")?-2

goal

id

goal-control-particle-size

category: Physical Property (CodeSystem - Test Category#C123456)

description: Controls - Particle Size ()

priority: Critical (CodeSystem - Goal Priority#critical)

Targets

-MeasureDetail[x]
*Under 200 microns (CodeSystem - Example Local Codes - Drug#particle-size "Particle Size")?-200

actor

Options

-TypeReferenceRole
*See above (DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d)Mixing Vessel (CodeSystem - Equipment Class#mixing-vessel)

actor

Options

-TypeReferenceRole
*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

-NameType
*Mixing VesselREGISTEREDNAME

Classifications

-Type
*Mixing Vessel (CodeSystem - Device Type#mixing-vessel)

Properties

-TypeValue[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

-NameType
*Receiving TankREGISTEREDNAME

Classifications

-Type
*Receiving Tank (CodeSystem - Device Type#receiving-tank)

Properties

-TypeValue[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: 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: 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: SUB3

instance: true

Codes

-Reference
*See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)