Pharmaceutical Quality (Industry)
1.0.0 - STU1

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 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; Pharmaceutical Plan Type Codes#process-validation "Process Validation")

> status: ACTIVE

> subject: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5

> description: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...

> > action

> > title: Formulation Buffer Preparation Process Parameter Step

> > code: Formulation Buffer Preparation Process Parameter Step (Manufacturing Step Codes#FormulationBufferPreparationProcessParameterStep)

> > > action

> > action

> > title: Formulation Buffer Preparation Performance Indicator Results

> > code: Formulation Buffer Preparation Performance Indicator Results (Manufacturing Step Codes#FormulationBufferPreparationPerformanceIndicatorStep)

> > > action

> > action

> > title: Thawing and Formulation Process Parameter Results

> > code: Thawing and Formulation Process Parameter Resultss (Manufacturing Step Codes#ThawingandFormulationProcessParameterResultsStep)

> > > action

> > action

> > title: Thawing and Formulation Performance Indicator Results

> > code: Thawing and Formulation Performance Indicator Results (Manufacturing Step Codes#ThawingandFormulationPerformanceIndicatorResultsStep)

> > > action

> > action

> > title: Bioburden Reduction Filtration Process Parameter Results

> > code: Bioburden Reduction Filtration Process Parameter Results (Manufacturing Step Codes#BioburdenReductionFiltrationProcessParameterResultsStep)

> > ### Actions

> > - | Code | Definition[x]
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434

> > action

> > title: Bioburden Reduction Filtration Performance Indicator Results

> > code: Bioburden Reduction Filtration Performance Indicator Results (Manufacturing Step Codes#BioburdenReductionFiltrationPerformanceIndicatorResultsStep)

> > ### Actions

> > - | Code | Definition[x]
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434

> > action

> > title: Media Challenge Hold Times

> > code: Media Challenge Hold Times (Manufacturing Step Codes#MediaChallengeHoldTimesStep)

> > ### Actions

> > - | Code | Definition[x]
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434

> > action

> > title: Media Challenge Results

> > code: Media Challenge Results (Manufacturing Step Codes#MediaChallengeResultsStep)

> > ### Actions

> > - | Code | Definition[x]
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524

> > action

> > title: Filtered Formulated Drug Product Performance Indicator Results

> > code: Filtered Formulated Drug Product Performance Indicator Results (Manufacturing Step Codes#FilteredFormulatedDrugProductPerformanceIndicatorResultsStep)

> > ### Actions

> > - | Code | Definition[x]
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424

> > action

> > title: Fill Weight Summary

> > code: Fill Weight Summary (Manufacturing Step Codes#FillWeightSummaryStep)

> > ### Actions

> > - | Code | Definition[x]
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524

> > action

> > title: Filling Homogeneity Quality Attributes

> > code: Filling Homogeneity Quality Attributes (Manufacturing Step Codes#FillingHomogeneityQualityAttributesStep)

> > ### Actions

> > - | Code | Definition[x]
> > * | Conclusion () | http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424

> > action

> > title: Filling Results Summary

> > code: Filling Results Summary (Manufacturing Step Codes#FillingResultsSummaryStep)

> > ### Actions

> > - | Code | Definition[x]
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524

> > action

> > title: Statistical Evaluation of Homogeneity Data

> > code: Statistical Evaluation of Homogeneity Data (Manufacturing Step Codes#StatisticalEvaluationOfHomogeneityDataStep)

> > ### Actions

> > - | Code | Definition[x]
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524

> > action

> > title: Consistency of the Lyophilization Process

> > code: Consistency of the Lyophilization Process (Manufacturing Step Codes#ConsistencyoftheLyophilizationProcessStep)

> > ### Actions

> > - | Code | Definition[x]
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72
> > * | Definition () | Lyophilization

> > action

> > title: Lyophilization Homogeneity

> > code: Lyophilization Homogeneity Results (Manufacturing Step Codes#LyophilizationHomogeneityStep)

> > ### Actions

> > - | Code | Definition[x]
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424

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"

> identifier: `urn:oid:2.16.840.1.113883.4.82`/3007270600

> active: true

> type: Analytical Testing - Release (Pharmaceutical Organization Type Codes#analytical-testing-release)

> name: Testing Lab

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) (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) (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) (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) (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 (Example Local Codes - Drug#Residual Moisture "Residual Moisture")

> ### QualifiedValues

> - | Range
> * | ?-7.15

> > component

> > code: Residual Moisture - Min (Example Local Codes - Drug#Residual Moisture - Min)

> > component

> > code: Residual Moisture - Max (Example Local Codes - Drug#Residual Moisture - Max)

> > component

> > code: Number of Samples (Example Local Codes - Drug#SAMP)

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 (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) (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 (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) (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 (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")

> ### QualifiedValues

> - | Extension | Range
> * |  | 85-95 %

> > component

> > code: SE-UHPLC Main Peak - Conclusion (Example Local Codes - Drug#SE-UHPLC Main Peak - Conclusion)

> > ### QualifiedValues

> > - | Extension
> > * |

> > component

> > code: Number of Samples (Example Local Codes - Drug#OVERALLSAMP)

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 (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")

> ### QualifiedValues

> - | Extension | Range
> * |  | 88-92 %

> > component

> > code: SE-UHPLC HMW - Conclusion (Example Local Codes - Drug#SE-UHPLC HMW - Conclusion)

> > ### QualifiedValues

> > - | Extension
> > * |

> > component

> > code: Number of Samples (Example Local Codes - Drug#OVERALLSAMP)

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 (%) (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) (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 (%) (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 (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 (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) (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) (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) (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) (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) (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) (Example Local Codes - Drug#Bioburden (CFU/ 100 mL))

> ### QualifiedValues

> - | Range
> * | ?-10

> > component

> > code: Bioburden - Beginning (Example Local Codes - Drug#Bioburden - Beginning)

> > component

> > code: Bioburden - End (Example Local Codes - Drug#Bioburden - End)

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 (Example Local Codes - Drug#Polysorbate 80 concentration - Middle - Max)

> ### QualifiedValues

> - | Range
> * | 0.5-1.5 % w/v

> > component

> > code: Polysorbate 80 concentration - Beginning - Min (Example Local Codes - Drug#Polysorbate 80 concentration - Beginning - Min)

> > component

> > code: Polysorbate 80 concentration - Beginning - Max (Example Local Codes - Drug#Polysorbate 80 concentration - Beginning - Max)

> > component

> > code: Polysorbate 80 concentration - Middle - Min (Example Local Codes - Drug#Polysorbate 80 concentration - Middle - Min)

> > component

> > code: Polysorbate 80 concentration - Middle - Max (Example Local Codes - Drug#Polysorbate 80 concentration - Middle - Max)

> > component

> > code: Polysorbate 80 concentration - End - Min (Example Local Codes - Drug#Polysorbate 80 concentration - End - Min)

> > component

> > code: Polysorbate 80 concentration - End - Max (Example Local Codes - Drug#Polysorbate 80 concentration - End - Max)

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) (Example Local Codes - Drug#Protein Concentration (mg/mL))

> ### QualifiedValues

> - | Range
> * | 8-10 (mg/mL)

> > component

> > code: Protein Concentration - Beginning - Min (Example Local Codes - Drug#Protein Concentration - Beginning - Min)

> > component

> > code: Protein Concentration - Beginning - Max (Example Local Codes - Drug#Protein Concentration - Beginning - Max)

> > component

> > code: Protein Concentration - Middle - Min (Example Local Codes - Drug#Protein Concentration - Middle - Min)

> > component

> > code: Protein Concentration - Middle - Max (Example Local Codes - Drug#Protein Concentration - Middle - Max)

> > component

> > code: Protein Concentration - End - Min (Example Local Codes - Drug#Protein Concentration - End - Min)

> > component

> > code: Protein Concentration - End - Max (Example Local Codes - Drug#Protein Concentration - End - Max)

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 (Example Local Codes - Drug#Protein Concentration Statistics)

> ### QualifiedValues

> - | Range
> * | 8-10 (mg/mL)

> > component

> > code: Protein Concentration - Beginning - Middle - Mean (Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Mean)

> > component

> > code: Protein Concentration - Beginning - End - Mean (Example Local Codes - Drug#Protein Concentration - Beginning - End - Mean)

> > component

> > code: Protein Concentration - Middle - End - Mean (Example Local Codes - Drug#Protein Concentration - Middle - End - Mean)

> > component

> > code: Protein Concentration - Beginning - Middle - Lower (Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Lower)

> > component

> > code: Protein Concentration - Beginning - End - Lower (Example Local Codes - Drug#Protein Concentration - Beginning - End - Lower)

> > component

> > code: Protein Concentration - Middle - End - Lower (Example Local Codes - Drug#Protein Concentration - Middle - End - Lower)

> > component

> > code: Protein Concentration - Beginning - Middle - Higher (Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Higher)

> > component

> > code: Protein Concentration - Beginning - End - Higher (Example Local Codes - Drug#Protein Concentration - Beginning - End - Higher)

> > component

> > code: Protein Concentration - Middle - End - Higher (Example Local Codes - Drug#Protein Concentration - Middle - End - Higher)

> > component

> > code: Protein Concentration - Conclusion (Example Local Codes - Drug#Protein Concentration - Conclusion)

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 (Example Local Codes - Drug#Fill Weight)

> ### QualifiedValues

> - | Extension | Range
> * |  | 95-105 g

> > component

> > code: Bioburden - Beginning (Example Local Codes - Drug#Bioburden - Beginning)

> > component

> > code: Bioburden - End (Example Local Codes - Drug#Bioburden - End)

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 (Example Local Codes - Drug#GrowthPromotion)

> ### QualifiedValues

> - | Extension
> * |

> > component

> > code: Growth Promotion - Beginning (Example Local Codes - Drug#Growth Promotion - Beginning)

> > component

> > code: Growth Promotion - End (Example Local Codes - Drug#Growth Promotion - End)

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) (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) (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) (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) (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) (Example Local Codes - Drug#Post-filtration Filter Integrity (psig))

> ### QualifiedValues

> - | Range
> * | 100-? psig

> ### Components

> - | Code
> * | Test Success (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 (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) (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: `urn:oid:2.16.840.1.113883.4.82`/3010027650

> active: true

> type: Drug Product Manufacture (Pharmaceutical Organization Type Codes#drug-product-manufacture)

> name: AAA Pharmaceutical, Inc.

> ### Contacts

> - | Address
> * | 681 Main Street Lumberton New Jersey 08048 USA

Entry 46 - fullUrl = urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b07

Resource Organization:

> Generated Narrative: Organization

> Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b07"

> identifier: `urn:oid:2.16.840.1.113883.4.82`/3008816891

> active: true

> type: Packaging (Pharmaceutical Organization Type Codes#packaging)

> name: MySite

Entry 47 - fullUrl = urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56948a-2a39-6609-1c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72

> status: FINAL

> code: Buffer vessel mixing speed (rpm) (Example Local Codes - Drug#Buffer vessel mixing speed (rpm))

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 205 rpm

Entry 48 - fullUrl = urn:uuid:9c56948a-3a39-6609-1c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56948a-3a39-6609-1c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72

> status: FINAL

> code: Buffer vessel mixing speed (rpm) (Example Local Codes - Drug#Buffer vessel mixing speed (rpm))

> subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 210 rpm

Entry 49 - fullUrl = urn:uuid:9c56948a-4a39-6609-1c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56948a-4a39-6609-1c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72

> status: FINAL

> code: Buffer vessel mixing speed (rpm) (Example Local Codes - Drug#Buffer vessel mixing speed (rpm))

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 198 rpm

Entry 50 - fullUrl = urn:uuid:9c56948a-2a39-6609-2c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56948a-2a39-6609-2c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73

> status: FINAL

> code: Buffer vessel mixing time (min) (Example Local Codes - Drug#Buffer vessel mixing time (min))

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 51 mins

Entry 51 - fullUrl = urn:uuid:9c56948a-3a39-6609-2c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56948a-3a39-6609-2c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73

> status: FINAL

> code: Buffer vessel mixing time (min) (Example Local Codes - Drug#Buffer vessel mixing time (min))

> subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 49 mins

Entry 52 - fullUrl = urn:uuid:9c56948a-4a39-6609-3c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56948a-4a39-6609-3c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73

> status: FINAL

> code: Buffer vessel mixing time (min) (Example Local Codes - Drug#Buffer vessel mixing time (min))

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 52 mins

Entry 53 - fullUrl = urn:uuid:44aa47fd-8964-4f96-6495-b2bec7f160e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "44aa47fd-8964-4f96-6495-b2bec7f160e7"

> instantiates: See on this page: ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72

> status: FINAL

> code: pH (Example Local Codes - Drug#pH)

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 6.9 pH

Entry 54 - fullUrl = urn:uuid:54aa47fd-8964-4f96-6495-b2bec7f160e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54aa47fd-8964-4f96-6495-b2bec7f160e7"

> instantiates: See on this page: ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72

> status: FINAL

> code: pH (Example Local Codes - Drug#pH)

> subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 7.1 pH

Entry 55 - fullUrl = urn:uuid:54aa48fd-8964-4f96-6495-b2bec7f160e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54aa48fd-8964-4f96-6495-b2bec7f160e7"

> instantiates: See on this page: ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72

> status: FINAL

> code: pH (Example Local Codes - Drug#pH)

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 7.2 pH

Entry 56 - fullUrl = urn:uuid:44aa47fd-9964-5f96-6495-b2bec7f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "44aa47fd-9964-5f96-6495-b2bec7f161e8"

> instantiates: See on this page: ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434

> status: FINAL

> code: Hold Time (hr) (Example Local Codes - Drug#Hold Time "Hold Time")

> subject: See on this page: Procedure/44aa47fd-8964-5f96-8495-b2bec7f161a8

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 1.25 hours

Entry 57 - fullUrl = urn:uuid:44aa47fd-8964-5f96-6495-b2bec7f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "44aa47fd-8964-5f96-6495-b2bec7f161e8"

> instantiates: See on this page: ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434

> status: FINAL

> code: Hold Time (hr) (Example Local Codes - Drug#Hold Time "Hold Time")

> subject: See on this page: Procedure/44aa47fd-8964-5f96-6495-b2bec7f162a8

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 1.5 hours

Entry 58 - fullUrl = urn:uuid:44aa47fd-8964-5f96-7495-b2bec7f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "44aa47fd-8964-5f96-7495-b2bec7f161e8"

> instantiates: See on this page: ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434

> status: FINAL

> code: Hold Time (hr) (Example Local Codes - Drug#Hold Time "Hold Time")

> subject: See on this page: Procedure/44aa47fd-8964-5f96-6495-b2bec7f163a8

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 1.75 hours

Entry 59 - fullUrl = urn:uuid:44aa47fd-9964-5f97-6495-b2bec7f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "44aa47fd-9964-5f97-6495-b2bec7f161e8"

> instantiates: See on this page: ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524

> status: FINAL

> code: Bioburden (CFU/ 100 mL) (Example Local Codes - Drug#Bioburden (CFU/ 100 mL))

> subject: See on this page: Procedure/44aa47fd-8964-5f96-8495-b2bec7f161a8

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: Bioburden - Beginning (Example Local Codes - Drug#Bioburden - Beginning)

> > value: 8.0 CFU/100 mL

> > component

> > code: Bioburden - End (Example Local Codes - Drug#Bioburden - End)

> > value: 9.0 CFU/100 mL

Entry 60 - fullUrl = urn:uuid:44aa47fd-8964-5f98-6495-b2bec7f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "44aa47fd-8964-5f98-6495-b2bec7f161e8"

> instantiates: See on this page: ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524

> status: FINAL

> code: Bioburden (CFU/ 100 mL) (Example Local Codes - Drug#Bioburden (CFU/ 100 mL))

> subject: See on this page: Procedure/44aa47fd-8964-5f96-6495-b2bec7f162a8

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: Bioburden - Beginning (Example Local Codes - Drug#Bioburden - Beginning)

> > value: 8.5 CFU/100 mL

> > component

> > code: Bioburden - End (Example Local Codes - Drug#Bioburden - End)

> > value: 8.6 CFU/100 mL

Entry 61 - fullUrl = urn:uuid:44aa47fd-8964-5f99-7495-b2bec7f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "44aa47fd-8964-5f99-7495-b2bec7f161e8"

> instantiates: See on this page: ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524

> status: FINAL

> code: Bioburden (CFU/ 100 mL) (Example Local Codes - Drug#Bioburden (CFU/ 100 mL))

> subject: See on this page: Procedure/44aa47fd-8964-5f96-6495-b2bec7f163a8

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: Bioburden - Beginning (Example Local Codes - Drug#Bioburden - Beginning)

> > value: 9.5 CFU/100 mL

> > component

> > code: Bioburden - End (Example Local Codes - Drug#Bioburden - End)

> > value: 10.1 CFU/100 mL

Entry 62 - fullUrl = urn:uuid:54aa47fd-9965-5f97-6495-b2bec8f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54aa47fd-9965-5f97-6495-b2bec8f161e8"

> instantiates: See on this page: ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534

> status: FINAL

> code: Protein Concentration (mg/mL) (Example Local Codes - Drug#Protein Concentration (mg/mL))

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: Protein Concentration - Beginning - Middle - Mean (Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Mean)

> > value: 8.0 mg/mL

> > component

> > code: Protein Concentration - Beginning - End - Mean (Example Local Codes - Drug#Protein Concentration - Beginning - End - Mean)

> > value: 8.05 mg/mL

> > component

> > code: Protein Concentration - Middle - End - Mean (Example Local Codes - Drug#Protein Concentration - Middle - End - Mean)

> > value: 8.10 mg/mL

> > component

> > code: Protein Concentration - Beginning - Middle - Lower (Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Lower)

> > value: 8.15 mg/mL

> > component

> > code: Protein Concentration - Beginning - End - Lower (Example Local Codes - Drug#Protein Concentration - Beginning - End - Lower)

> > value: 8.2 mg/mL

> > component

> > code: Protein Concentration - Middle - End - Lower (Example Local Codes - Drug#Protein Concentration - Middle - End - Lower)

> > value: 8.25 mg/mL

> > component

> > code: Protein Concentration - Beginning - Middle - Higher (Example Local Codes - Drug#Protein Concentration - Beginning - Middle - Higher)

> > value: 8.45 mg/mL

> > component

> > code: Protein Concentration - Beginning - End - Higher (Example Local Codes - Drug#Protein Concentration - Beginning - End - Higher)

> > value: 8.3 mg/mL

> > component

> > code: Protein Concentration - Middle - End - Higher (Example Local Codes - Drug#Protein Concentration - Middle - End - Higher)

> > value: 8.35 mg/mL

> > component

> > code: Protein Concentration - Conclusion (Example Local Codes - Drug#Protein Concentration - Conclusion)

> > value: Pass

Entry 63 - fullUrl = urn:uuid:54aa47fd-9964-5f97-6495-b2bec8f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54aa47fd-9964-5f97-6495-b2bec8f161e8"

> instantiates: See on this page: ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524

> status: FINAL

> code: Protein Concentration (mg/mL) (Example Local Codes - Drug#Protein Concentration (mg/mL))

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: Protein Concentration - Beginning - Min (Example Local Codes - Drug#Protein Concentration - Beginning - Min)

> > value: 8.00 mg/mL

> > component

> > code: Protein Concentration - Beginning - Max (Example Local Codes - Drug#Protein Concentration - Beginning - Max)

> > value: 8.05 mg/mL

> > component

> > code: Protein Concentration - Middle - Min (Example Local Codes - Drug#Protein Concentration - Middle - Min)

> > value: 8.10 mg/mL

> > component

> > code: Protein Concentration - Middle - Max (Example Local Codes - Drug#Protein Concentration - Middle - Max)

> > value: 8.15 mg/mL

> > component

> > code: Protein Concentration - End - Min (Example Local Codes - Drug#Protein Concentration - End - Min)

> > value: 8.2 mg/mL

> > component

> > code: Protein Concentration - End - Max (Example Local Codes - Drug#Protein Concentration - End - Max)

> > value: 8.25 mg/mL

Entry 64 - fullUrl = urn:uuid:54aa47fd-9964-5f97-6495-b2bec8f162e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54aa47fd-9964-5f97-6495-b2bec8f162e8"

> instantiates: See on this page: ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524

> status: FINAL

> code: Polysorbate 80 concentration (% w/v) (Example Local Codes - Drug#Polysorbate 80 concentration (% w/v))

> subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: Polysorbate 80 concentration - Beginning - Min (Example Local Codes - Drug#Polysorbate 80 concentration - Beginning - Min)

> > value: 1.0 % w/v

> > component

> > code: Polysorbate 80 concentration - Beginning - Max (Example Local Codes - Drug#Polysorbate 80 concentration - Beginning - Max)

> > value: 1.05 % w/v

> > component

> > code: Polysorbate 80 concentration - Middle - Min (Example Local Codes - Drug#Polysorbate 80 concentration - Middle - Min)

> > value: 1.10 % w/v

> > component

> > code: Polysorbate 80 concentration - Middle - Max (Example Local Codes - Drug#Polysorbate 80 concentration - Middle - Max)

> > value: 1.15 % w/v

> > component

> > code: Polysorbate 80 concentration - End - Min (Example Local Codes - Drug#Polysorbate 80 concentration - End - Min)

> > value: 1.2 % w/v

> > component

> > code: Polysorbate 80 concentration - End - Max (Example Local Codes - Drug#Polysorbate 80 concentration - End - Max)

> > value: 1.25 % w/v

Entry 65 - fullUrl = urn:uuid:54aa47fd-9964-5f97-6495-b2bec7f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54aa47fd-9964-5f97-6495-b2bec7f161e8"

> instantiates: See on this page: ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524

> status: FINAL

> code: Growth Promotion (Example Local Codes - Drug#GrowthPromotion)

> subject: See on this page: Procedure/44aa47fd-8964-5f96-8495-b2bec7f161a8

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: Growth Promotion - Beginning (Example Local Codes - Drug#Growth Promotion - Beginning)

> > value: Pass

> > component

> > code: Growth Promotion - End (Example Local Codes - Drug#Growth Promotion - End)

> > value: Pass

Entry 66 - fullUrl = urn:uuid:64aa47fd-8964-5f98-6495-b2bec7f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "64aa47fd-8964-5f98-6495-b2bec7f161e8"

> instantiates: See on this page: ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524

> status: FINAL

> code: Growth Promotion (Example Local Codes - Drug#GrowthPromotion)

> subject: See on this page: Procedure/44aa47fd-8964-5f96-6495-b2bec7f162a8

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: Growth Promotion - Beginning (Example Local Codes - Drug#Growth Promotion - Beginning)

> > value: Pass

> > component

> > code: Growth Promotion - End (Example Local Codes - Drug#Growth Promotion - End)

> > value: Pass

Entry 67 - fullUrl = urn:uuid:74aa47fd-8964-5f99-7495-b2bec7f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "74aa47fd-8964-5f99-7495-b2bec7f161e8"

> instantiates: See on this page: ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524

> status: FINAL

> code: Growth Promotion (Example Local Codes - Drug#GrowthPromotion)

> subject: See on this page: Procedure/44aa47fd-8964-5f96-6495-b2bec7f163a8

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: Growth Promotion - Beginning (Example Local Codes - Drug#Growth Promotion - Beginning)

> > value: Pass

> > component

> > code: Growth Promotion - End (Example Local Codes - Drug#Growth Promotion - End)

> > value: Fail

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 (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 (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 (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 (Example Local Codes - Drug#LyophilizationHomogeneneity)

> subject: : Drug batch

> ### Performers

> - | Actor
> > * | ### Definitions
> > - | Reference
> > * | See on this page: #DDLyo1

> > Generated Narrative: Device #device-nosubject

> > ### Definitions

> > - | Reference
> > * | See on this page: #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 on this page: ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434

> status: FINAL

> code: Post-filtration Filter Integrity (psig) (Example Local Codes - Drug#Post-filtration Filter Integrity (psig))

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 280 mOsm/kg

> ### Components

> - | Code | Value[x]
> * | Test Success (Example Local Codes - Drug#test-success) | Pass ()

Entry 73 - fullUrl = urn:uuid:44aa47fd-8964-4f96-6495-b2bec7f161e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "44aa47fd-8964-4f96-6495-b2bec7f161e7"

> instantiates: See on this page: ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424

> status: FINAL

> code: osmolality (Example Local Codes - Drug#Osmolality "Osmolality")

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 280 mOsm/kg

Entry 74 - fullUrl = urn:uuid:54aa47fd-8964-4f96-6495-b2bec7f162e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54aa47fd-8964-4f96-6495-b2bec7f162e7"

> instantiates: See on this page: ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424

> status: FINAL

> code: osmolality (Example Local Codes - Drug#Osmolality "Osmolality")

> subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 285 mOsm/kg

Entry 75 - fullUrl = urn:uuid:54aa48fd-8964-4f96-6495-b2bec7f163e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54aa48fd-8964-4f96-6495-b2bec7f163e7"

> instantiates: See on this page: ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424

> status: FINAL

> code: osmolality (Example Local Codes - Drug#Osmolality "Osmolality")

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 290 mOsm/kg

Entry 76 - fullUrl = urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "44ba47fd-8964-4f96-6495-b2bec7f161e8"

> instantiates: See on this page: ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72

> status: FINAL

> code: Residual Moisture (%) (Example Local Codes - Drug#Residual Moisture "Residual Moisture")

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: Residual Moisture - Min (Example Local Codes - Drug#Residual Moisture - Min)

> > value: 3.1 %

> > component

> > code: Residual Moisture - Max (Example Local Codes - Drug#Residual Moisture - Max)

> > value: 3.2 %

> > component

> > code: Number of Samples (Example Local Codes - Drug#SAMP)

> > value: 2

Entry 77 - fullUrl = urn:uuid:44ba47fd-9964-4f96-6495-b2bec7f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "44ba47fd-9964-4f96-6495-b2bec7f161e8"

> instantiates: See on this page: ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72

> status: FINAL

> code: Residual Moisture (%) (Example Local Codes - Drug#Residual Moisture "Residual Moisture")

> subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 4.2 %

> ### Components

> - | Code | Value[x]
> * | Number of Samples (Example Local Codes - Drug#SAMP) | 3

Entry 78 - fullUrl = urn:uuid:44ba47fd-9964-4f96-6496-b2bec7f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "44ba47fd-9964-4f96-6496-b2bec7f161e8"

> instantiates: See on this page: ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72

> status: FINAL

> code: Residual Moisture (%) (Example Local Codes - Drug#Residual Moisture "Residual Moisture")

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 4.4 %

> ### Components

> - | Code | Value[x]
> * | Number of Samples (Example Local Codes - Drug#SAMP) | 3

Entry 79 - fullUrl = urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "44ba47fd-8964-4f96-6495-b2bec7f161e7"

> instantiates: See on this page: ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: SE-UHPLC Main Peak - Beginning (Example Local Codes - Drug#SE-UHPLC Main Peak - Beginning)

> > value: 8.0 %

> > component

> > code: SE-UHPLC Main Peak - End (Example Local Codes - Drug#SE-UHPLC Main Peak - End)

> > value: 8.5 %

Entry 80 - fullUrl = urn:uuid:54ca47fd-8964-4f96-6495-b2bec7f162e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54ca47fd-8964-4f96-6495-b2bec7f162e7"

> instantiates: See on this page: ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")

> subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: SE-UHPLC Main Peak - Beginning (Example Local Codes - Drug#SE-UHPLC Main Peak - Beginning)

> > value: 9.0 %

> > component

> > code: SE-UHPLC Main Peak - End (Example Local Codes - Drug#SE-UHPLC Main Peak - End)

> > value: 9.5 %

Entry 81 - fullUrl = urn:uuid:54da48fd-8964-4f96-6495-b2bec7f163e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54da48fd-8964-4f96-6495-b2bec7f163e7"

> instantiates: See on this page: ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: SE-UHPLC Main Peak - Beginning (Example Local Codes - Drug#SE-UHPLC Main Peak - Beginning)

> > value: 10.0 %

> > component

> > code: SE-UHPLC Main Peak - End (Example Local Codes - Drug#SE-UHPLC Main Peak - End)

> > value: 10.5 %

Entry 82 - fullUrl = urn:uuid:44ba47fd-8964-5f96-6495-b2bec7f161e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "44ba47fd-8964-5f96-6495-b2bec7f161e7"

> instantiates: See on this page: ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC Main Peak (Graph) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value:

Entry 83 - fullUrl = urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54ba47fd-8964-4f96-6495-b2bec7f161e7"

> instantiates: See on this page: ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 91 %

Entry 84 - fullUrl = urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54ba47fd-8964-4f96-6495-b2bec7f161e8"

> instantiates: See on this page: ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")

> subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 89 %

Entry 85 - fullUrl = urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e9

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54ba47fd-8964-4f96-6495-b2bec7f161e9"

> instantiates: See on this page: ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 92 %

Entry 86 - fullUrl = urn:uuid:54ba48fd-8964-4f96-6495-b2bec7f161e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54ba48fd-8964-4f96-6495-b2bec7f161e7"

> instantiates: See on this page: ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")

> subject: : Product

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: Number of Samples (Example Local Codes - Drug#SAMP)

> > value: 12

> > component

> > code: SE-UHPLC Main Peak Conclusion (Example Local Codes - Drug#SE-UHPLCMainPeak - Conclusion "SE-UHPLC Main Peak - Conclusion")

> > value: Pass

Entry 87 - fullUrl = urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54bb47fd-8964-4f96-6495-b2bec7f161e7"

> instantiates: See on this page: ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC HMW (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 88 %

Entry 88 - fullUrl = urn:uuid:54ba47fd-9964-4f96-6495-b2bec7f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54ba47fd-9964-4f96-6495-b2bec7f161e8"

> instantiates: See on this page: ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC HMW (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")

> subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 93 %

Entry 89 - fullUrl = urn:uuid:54ba47fe-8964-4f96-6495-b2bec7f161e9

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54ba47fe-8964-4f96-6495-b2bec7f161e9"

> instantiates: See on this page: ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC HMW (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> value: 99 %

Entry 90 - fullUrl = urn:uuid:64ba48fd-8964-4f96-6495-b2bec7f161e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "64ba48fd-8964-4f96-6495-b2bec7f161e7"

> instantiates: See on this page: ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC HMW (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")

> subject: : Product

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: Number of Samples (Example Local Codes - Drug#SAMP)

> > value: 9

> > component

> > code: SE-UHPLC HMW Conclusion (Example Local Codes - Drug#SE-UHPLCHMWPeak - Conclusion "SE-UHPLC HMW Peak - Conclusion")

> > value: Fail

Entry 91 - fullUrl = urn:uuid:44ba47fd-8964-4f97-6495-b2bec7f161e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "44ba47fd-8964-4f97-6495-b2bec7f161e7"

> instantiates: See on this page: ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC HMW (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: SE-UHPLC HMW - Beginning (Example Local Codes - Drug#SE-UHPLCHMW - Beginning)

> > value: 7.0 %

> > component

> > code: SE-UHPLC HMW - End (Example Local Codes - Drug#SE-UHPLCHMW - End)

> > value: 7.5 %

Entry 92 - fullUrl = urn:uuid:54ca47fd-8964-4f98-6495-b2bec7f162e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54ca47fd-8964-4f98-6495-b2bec7f162e7"

> instantiates: See on this page: ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC HMW (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")

> subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: SE-UHPLC HMW - Beginning (Example Local Codes - Drug#SE-UHPLCHMW - Beginning)

> > value: 8.0 %

> > component

> > code: SE-UHPLC HMW - End (Example Local Codes - Drug#SE-UHPLCHMW - End)

> > value: 8.5 %

Entry 93 - fullUrl = urn:uuid:54da48fd-8964-4f99-6495-b2bec7f163e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54da48fd-8964-4f99-6495-b2bec7f163e7"

> instantiates: See on this page: ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: SE-UHPLC HMW - Beginning (Example Local Codes - Drug#SE-UHPLCHMW - Beginning)

> > value: 9.0 %

> > component

> > code: SE-UHPLC HMW - End (Example Local Codes - Drug#SE-UHPLCHMW - End)

> > value: 9.5 %

Entry 94 - fullUrl = urn:uuid:55aa47fd-9964-5f97-6495-b2bec7f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "55aa47fd-9964-5f97-6495-b2bec7f161e8"

> instantiates: See on this page: ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524

> status: FINAL

> code: Fill Weight (Example Local Codes - Drug#Fill Weight)

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

> effective: 2023-01-01 12:00:00+0000

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: Fill Weight - Minimum (Example Local Codes - Drug#Fill Weight - Minimum)

> > value: 9.90 g

> > component

> > code: Fill Weight - Maximum (Example Local Codes - Drug#Fill Weight - Maximum)

> > value: 9.92 g

> > component

> > code: Fill Weight - Mean (Example Local Codes - Drug#Fill Weight - Mean)

> > value: 9.91 CFU/100 mL

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 (Product Name Type - example#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 on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5

> role: Active (Ingredient Role#100000072072)

> > substance

> > ### Codes

> > - | Reference
> > * | See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390

Entry 98 - fullUrl = urn:uuid:57a9af63-315d-1585-a261-0e337b289390

Resource SubstanceDefinition:

> Generated Narrative: SubstanceDefinition

> Resource SubstanceDefinition "57a9af63-315d-1585-a261-0e337b289390"

> manufacturer: See on this page: 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

> active: true

> type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#drug-substance-manufacture)

> name: AAA Molybdenum Products, Inc.

> ### Contacts

> - | Address
> * | 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA

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; Pharmaceutical Plan Type Codes#manufacturing-process "Manufacturing Process")

> status: ACTIVE

> subject: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5

> description: Narrative description of manufacturing process (5)

> > goal

> > > id

> > > goal-control-pH

> > category: Physical Property (Pharmaceutical Test Category Codes#C123456)

> > description: Controls - pH ()

> > priority: Critical (Goal Priority - example#critical)

> > ### Targets

> > - | Measure | Detail[x]
> > * | pH must be in range 6.9 to 7.1 (Example Local Codes - Drug#pH "pH") | 6.9-7.1 pH

> > goal

> > > id

> > > goal-control-water-content

> > category: Physical Property (Pharmaceutical Test Category Codes#C123456)

> > description: Controls - Water Content ()

> > priority: Critical (Goal Priority - example#critical)

> > ### Targets

> > - | Measure | Detail[x]
> > * | Under 2% (Example Local Codes - Drug#WaterContent "Water content") | ?-2

> > goal

> > > id

> > > goal-control-particle-size

> > category: Physical Property (Pharmaceutical Test Category Codes#C123456)

> > description: Controls - Particle Size ()

> > priority: Critical (Goal Priority - example#critical)

> > ### Targets

> > - | Measure | Detail[x]
> > * | Under 200 microns (Example Local Codes - Drug#particle-size "Particle Size") | ?-200

> > actor

> > ### Options

> > - | TypeReference | Role
> > * | See on this page: DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d | Mixing Vessel (Pharmaceutical Manufacturing Equipment Class Codes#mixing-vessel)

> > actor

> > ### Options

> > - | TypeReference | Role
> > * | See on this page: DeviceDefinition/82a39a18-91cf-b29d-76c1-a9e8bad9494d | Receiving Vessel (Pharmaceutical Manufacturing Equipment Class Codes#receiving-vessel)

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 (Device Type - example#mixing-vessel)

> ### Properties

> - | Type | Value[x]
> * | Capacity (Device Property Codes#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 (Device Type - example#receiving-tank)

> ### Properties

> - | Type | Value[x]
> * | Capacity (Device Property Codes#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 on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c

> Extension - Batch Release Date PQ: 2019-09-08

> Extension - Batch Retest Date PQ: 2022-09-08

> Extension - Actual Yield PQ: 4.8 kg

> identifier: CAT1

> instance: true

> ### Codes

> - | Reference
> * | See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390

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 on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c

> Extension - Batch Release Date PQ: 2019-09-08

> Extension - Batch Retest Date PQ: 2022-09-08

> Extension - Actual Yield PQ: 4.8 kg

> identifier: SUB2

> instance: true

> ### Codes

> - | Reference
> * | See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390

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 on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c

> Extension - Batch Release Date PQ: 2019-09-08

> Extension - Batch Retest Date PQ: 2022-09-08

> Extension - Actual Yield PQ: 4.8 kg

> identifier: SUB3

> instance: true

> ### Codes

> - | Reference
> * | See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390