bundle-product-process-validation-pq-ex1 - Pharmaceutical Quality (Industry) v1.0.0

Pharmaceutical Quality (Industry)
1.0.0 - STU1 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 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: bundle-product-process-validation-pq-ex1

Language: en

Profile: Bundle - Product Process Validation PQ

Bundle bundle-product-process-validation-pq-ex1 of type collection

Entry 1 - fullUrl = urn:uuid:1h1h1h1h-1h1h-1h1h-1h1h-1h1h1h1h1h1h

Resource MedicinalProductDefinition:

Language: en
Profile: MedicinalProductDefinition - Drug Product PQ
identifier: http://example.org/identifiers/product/PROD-12345
combinedPharmaceuticalDoseForm: Tablet
route: Oral use
Names
- ProductName Type
* Stelbatolol 10mg Tablets Invented Name

Entry 2 - fullUrl = urn:uuid:2h2h2h2h-2h2h-2h2h-2h2h-2h2h2h2h2h2h

Resource Ingredient:

Language: en
Profile: Ingredient - Drug Pq
status: Active
role: Active
substance
Codes
- Reference
* SubstanceDefinition: status = Active

Entry 3 - fullUrl = urn:uuid:3h3h3h3h-3h3h-3h3h-3h3h-3h3h3h3h3h3h

Resource SubstanceDefinition:

Language: en
Profile: SubstanceDefinition - Component Substance Drug PQ
status: Active
manufacturer: Organization AAA Molybdenum Products, Inc.
Names
- Name
* Stelbatolol Hydrochloride

Entry 4 - fullUrl = urn:uuid:4h4h4h4h-4h4h-4h4h-4h4h-4h4h4h4h4h4h

Resource Medication:

Language: en
Profile: Medication - Batch Information Drug PQ
code:
batch
Medication Manufacturing Batch
url
manufacturingDate
value: 2020-06
url
batchQuantity
value: 100100 tablets
url
batchUtilization
value: Production
url
assignedManufacturer
value: Organization AAA Molybdenum Products, Inc.
closureSystemDescription: 100 cc HDPE Bottle 2 g desiccant
url
container
Extension - Batch Release Date PQ: 2019-09-08
Extension - Batch Designation PQ: Maximum
Extension - Batch Number of Vials PQ: 3
Extension - Batch Substance Batch PQ: Substance
Extension - Packaging Date PQ: 2020-08
Extension - Packaging Site PQ: Organization AAA Molybdenum Products, Inc.
Extension - Actual Yield PQ: 4.81 kg
Extension - Actual Yield Unfiltered PQ: 4.91 kg
Extension Target Fill Weight PQ: 30 g
lotNumber: 33445

Entry 5 - fullUrl = urn:uuid:5h5h5h5h-5h5h-5h5h-5h5h-5h5h5h5h5h5h

Resource Substance:

Language: en
Profile: Substance - Drug PQ
Medication Manufacturing Batch
manufacturingDate: 2019-09-07
batchQuantity: 5 kg
batchUtilization: Development
assignedManufacturer: Organization AAA Molybdenum Products, Inc.
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: false
Codes
- Concept
* Substance

Entry 6 - fullUrl = urn:uuid:6h6h6h6h-6h6h-6h6h-6h6h-6h6h6h6h6h6h

Resource PlanDefinition:

Metadata

Title DP PROCESS VALIDATION

Subject Type MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use

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

Type Workflow Definition Process Validation

PlanDefinition Action

Title Formulation Buffer Preparation Process Parameter Step

Code Formulation Buffer Preparation Process Parameter Step

PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)

Title Formulation Buffer Preparation Process Parameter Step

Code FormulationBufferPreparationProcessParameterStep

PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)

Code Conclusion

Definition http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424

PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72

PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73

PlanDefinition Action

Title Formulation Buffer Preparation Performance Indicator Results

Code Formulation Buffer Preparation Performance Indicator Results

PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Performance Indicator Results)

Title ???

Code ???

PlanDefinition Sub-Action (Parent Action Title: ???)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72

PlanDefinition Sub-Action (Parent Action Title: ???)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424

PlanDefinition Sub-Action (Parent Action Title: ???)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-939ce1958424

PlanDefinition Sub-Action (Parent Action Title: ???)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958424

PlanDefinition Sub-Action (Parent Action Title: ???)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958424

PlanDefinition Action

Title Thawing and Formulation Process Parameter Results

Code Thawing and Formulation Process Parameter Resultss

PlanDefinition Sub-Action (Parent Action Title: Thawing and Formulation Process Parameter Results)

Title ???

Code ???

PlanDefinition Sub-Action (Parent Action Title: ???)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/74515a3c-5034-448a-9c19-938ce1958424

PlanDefinition Sub-Action (Parent Action Title: ???)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe2-91c2-2d16-47cb5b295e72

PlanDefinition Sub-Action (Parent Action Title: ???)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72

PlanDefinition Sub-Action (Parent Action Title: ???)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/fc27b5d5-9fe1-92c2-2d06-47cb5b295e73

PlanDefinition Action

Title Thawing and Formulation Performance Indicator Results

Code Thawing and Formulation Performance Indicator Results

PlanDefinition Sub-Action (Parent Action Title: Thawing and Formulation Performance Indicator Results)

Title ???

Code ???

PlanDefinition Sub-Action (Parent Action Title: ???)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-47cb5b295e72

PlanDefinition Sub-Action (Parent Action Title: ???)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424

PlanDefinition Sub-Action (Parent Action Title: ???)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/74515a3c-5134-448a-9c19-939ce1958424

PlanDefinition Sub-Action (Parent Action Title: ???)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/64515b4c-5134-448a-9c19-949ce1958424

PlanDefinition Sub-Action (Parent Action Title: ???)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958434

PlanDefinition Action

Title Bioburden Reduction Filtration Process Parameter Results

Code Bioburden Reduction Filtration Process Parameter Results

PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Process Parameter Results)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434

PlanDefinition Action

Title Bioburden Reduction Filtration Performance Indicator Results

Code Bioburden Reduction Filtration Performance Indicator Results

PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Performance Indicator Results)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434

PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Performance Indicator Results)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434

PlanDefinition Action

Title Media Challenge Hold Times

Code Media Challenge Hold Times

PlanDefinition Sub-Action (Parent Action Title: Media Challenge Hold Times)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434

PlanDefinition Action

Title Media Challenge Results

Code Media Challenge Results

PlanDefinition Sub-Action (Parent Action Title: Media Challenge Results)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524

PlanDefinition Sub-Action (Parent Action Title: Media Challenge Results)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524

PlanDefinition Action

Title Filtered Formulated Drug Product Performance Indicator Results

Code Filtered Formulated Drug Product Performance Indicator Results

PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424

PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424

PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424

PlanDefinition Action

Title Fill Weight Summary

Code Fill Weight Summary

PlanDefinition Sub-Action (Parent Action Title: Fill Weight Summary)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524

PlanDefinition Action

Title Filling Homogeneity Quality Attributes

Code Filling Homogeneity Quality Attributes

PlanDefinition Sub-Action (Parent Action Title: Filling Homogeneity Quality Attributes)

Code Conclusion

Definition http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424

PlanDefinition Action

Title Filling Results Summary

Code Filling Results Summary

PlanDefinition Sub-Action (Parent Action Title: Filling Results Summary)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524

PlanDefinition Sub-Action (Parent Action Title: Filling Results Summary)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524

PlanDefinition Action

Title Statistical Evaluation of Homogeneity Data

Code Statistical Evaluation of Homogeneity Data

PlanDefinition Sub-Action (Parent Action Title: Statistical Evaluation of Homogeneity Data)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534

PlanDefinition Sub-Action (Parent Action Title: Statistical Evaluation of Homogeneity Data)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524

PlanDefinition Action

Title Consistency of the Lyophilization Process

Code Consistency of the Lyophilization Process

PlanDefinition Sub-Action (Parent Action Title: Consistency of the Lyophilization Process)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72

PlanDefinition Sub-Action (Parent Action Title: Consistency of the Lyophilization Process)

Code Definition

Definition http://example-server.com/fhir/ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bd

PlanDefinition Action

Title Lyophilization Homogeneity

Code Lyophilization Homogeneity Results

PlanDefinition Sub-Action (Parent Action Title: Lyophilization Homogeneity)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424

PlanDefinition Sub-Action (Parent Action Title: Lyophilization Homogeneity)

Code Test

Definition http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424

Generated using version 0.5.4 of the sample-content-ig Liquid templates

Metadata
Title	DP PROCESS VALIDATION
Subject Type	MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use
Description	Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...
Type	Workflow Definition Process Validation
PlanDefinition Action
Title	Formulation Buffer Preparation Process Parameter Step
Code	Formulation Buffer Preparation Process Parameter Step
PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)
Title	Formulation Buffer Preparation Process Parameter Step
Code	FormulationBufferPreparationProcessParameterStep
PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)
Code	Conclusion
Definition	`http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424`
PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72`
PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73`
PlanDefinition Action
Title	Formulation Buffer Preparation Performance Indicator Results
Code	Formulation Buffer Preparation Performance Indicator Results
PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Performance Indicator Results)
Title	???
Code	???
PlanDefinition Sub-Action (Parent Action Title: ???)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72`
PlanDefinition Sub-Action (Parent Action Title: ???)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424`
PlanDefinition Sub-Action (Parent Action Title: ???)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-939ce1958424`
PlanDefinition Sub-Action (Parent Action Title: ???)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958424`
PlanDefinition Sub-Action (Parent Action Title: ???)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958424`
PlanDefinition Action
Title	Thawing and Formulation Process Parameter Results
Code	Thawing and Formulation Process Parameter Resultss
PlanDefinition Sub-Action (Parent Action Title: Thawing and Formulation Process Parameter Results)
Title	???
Code	???
PlanDefinition Sub-Action (Parent Action Title: ???)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/74515a3c-5034-448a-9c19-938ce1958424`
PlanDefinition Sub-Action (Parent Action Title: ???)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe2-91c2-2d16-47cb5b295e72`
PlanDefinition Sub-Action (Parent Action Title: ???)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72`
PlanDefinition Sub-Action (Parent Action Title: ???)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/fc27b5d5-9fe1-92c2-2d06-47cb5b295e73`
PlanDefinition Action
Title	Thawing and Formulation Performance Indicator Results
Code	Thawing and Formulation Performance Indicator Results
PlanDefinition Sub-Action (Parent Action Title: Thawing and Formulation Performance Indicator Results)
Title	???
Code	???
PlanDefinition Sub-Action (Parent Action Title: ???)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-47cb5b295e72`
PlanDefinition Sub-Action (Parent Action Title: ???)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424`
PlanDefinition Sub-Action (Parent Action Title: ???)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/74515a3c-5134-448a-9c19-939ce1958424`
PlanDefinition Sub-Action (Parent Action Title: ???)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/64515b4c-5134-448a-9c19-949ce1958424`
PlanDefinition Sub-Action (Parent Action Title: ???)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958434`
PlanDefinition Action
Title	Bioburden Reduction Filtration Process Parameter Results
Code	Bioburden Reduction Filtration Process Parameter Results
PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Process Parameter Results)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434`
PlanDefinition Action
Title	Bioburden Reduction Filtration Performance Indicator Results
Code	Bioburden Reduction Filtration Performance Indicator Results
PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Performance Indicator Results)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434`
PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Performance Indicator Results)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434`
PlanDefinition Action
Title	Media Challenge Hold Times
Code	Media Challenge Hold Times
PlanDefinition Sub-Action (Parent Action Title: Media Challenge Hold Times)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434`
PlanDefinition Action
Title	Media Challenge Results
Code	Media Challenge Results
PlanDefinition Sub-Action (Parent Action Title: Media Challenge Results)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524`
PlanDefinition Sub-Action (Parent Action Title: Media Challenge Results)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524`
PlanDefinition Action
Title	Filtered Formulated Drug Product Performance Indicator Results
Code	Filtered Formulated Drug Product Performance Indicator Results
PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424`
PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424`
PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424`
PlanDefinition Action
Title	Fill Weight Summary
Code	Fill Weight Summary
PlanDefinition Sub-Action (Parent Action Title: Fill Weight Summary)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524`
PlanDefinition Action
Title	Filling Homogeneity Quality Attributes
Code	Filling Homogeneity Quality Attributes
PlanDefinition Sub-Action (Parent Action Title: Filling Homogeneity Quality Attributes)
Code	Conclusion
Definition	`http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424`
PlanDefinition Action
Title	Filling Results Summary
Code	Filling Results Summary
PlanDefinition Sub-Action (Parent Action Title: Filling Results Summary)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524`
PlanDefinition Sub-Action (Parent Action Title: Filling Results Summary)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524`
PlanDefinition Action
Title	Statistical Evaluation of Homogeneity Data
Code	Statistical Evaluation of Homogeneity Data
PlanDefinition Sub-Action (Parent Action Title: Statistical Evaluation of Homogeneity Data)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534`
PlanDefinition Sub-Action (Parent Action Title: Statistical Evaluation of Homogeneity Data)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524`
PlanDefinition Action
Title	Consistency of the Lyophilization Process
Code	Consistency of the Lyophilization Process
PlanDefinition Sub-Action (Parent Action Title: Consistency of the Lyophilization Process)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72`
PlanDefinition Sub-Action (Parent Action Title: Consistency of the Lyophilization Process)
Code	Definition
Definition	`http://example-server.com/fhir/ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bd`
PlanDefinition Action
Title	Lyophilization Homogeneity
Code	Lyophilization Homogeneity Results
PlanDefinition Sub-Action (Parent Action Title: Lyophilization Homogeneity)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424`
PlanDefinition Sub-Action (Parent Action Title: Lyophilization Homogeneity)
Code	Test
Definition	`http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424`
Generated using version 0.5.4 of the sample-content-ig Liquid templates

Entry 7 - fullUrl = urn:uuid:7h7h7h7h-7h7h-7h7h-7h7h-7h7h7h7h7h7h

Resource ActivityDefinition:

Metadata

Title Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ.

Generated using version 0.5.4 of the sample-content-ig Liquid templates

Metadata
Title	Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ.
Generated using version 0.5.4 of the sample-content-ig Liquid templates

Entry 8 - fullUrl = urn:uuid:8h8h8h8h-8h8h-8h8h-8h8h-8h8h8h8h8h8h

Resource ObservationDefinition:

Language: en
Profile: ObservationDefinition - Test Method PQ
status: Active
code: Assay
method: Assay by UHPLC

Entry 9 - fullUrl = urn:uuid:9h9h9h9h-9h9h-9h9h-9h9h-9h9h9h9h9h9h

Resource DeviceDefinition:

Language: en
Profile: DeviceDefinition - Drug PQ
DeviceNames
- Name Type
* Rotating Impeller with 1.5mm screen Registered name
Properties
- Type Value[x]
* Maximum Speed 5000 RPM

Entry 10 - fullUrl = urn:uuid:0j0j0j0j-0j0j-0j0j-0j0j-0j0j0j0j0j0j

Resource DiagnosticReport:

Language: en
Profile: DiagnosticReport - Analysis Drug PQ
Stability Study Report - 18 months
When For 2020-12
Performer Organization AAA Molybdenum Products, Inc.
Identifier https://eudract.europa.eu/example/identifier/ABC1234
Report Details
Code Value Flags When For
Test Components - Long-term 25C etc - Initial (XYZ) Final 2023-01-01 12:00:00+0000
The samples have been assessed for initial period; no shelf life determined.

Entry 11 - fullUrl = urn:uuid:1j1j1j1j-1j1j-1j1j-1j1j-1j1j1j1j1j1j

Resource Procedure:

Language: en
Profile: Procedure - Drug PQ
identifier: Run 1
status: Completed
code: Media Challenge Run
subject: Drug product

Entry 12 - fullUrl = urn:uuid:2j2j2j2j-2j2j-2j2j-2j2j-2j2j2j2j2j2j

Resource Observation:

Language: en
Profile: Observation - Test Result Drug PQ
status: Final
code: Degradation Products
subject: Medication
effective: 2023-01-01 12:00:00+0000
performer: Organization AAA Molybdenum Products, Inc.
value: 0.801 % w/w (Details: UCUM code% = '%')
Components
- Code Value[x]
* Impurity Total Degradation Impurities

Entry 13 - fullUrl = urn:uuid:3j3j3j3j-3j3j-3j3j-3j3j-3j3j3j3j3j3j

Resource Organization:

Language: en
Profile: Organization - Drug PQ
identifier: FDA Establishment Identifier/3003040516
active: true
type: Drug Substance Manufacture
name: AAA Molybdenum Products, Inc.
Contacts
- Address
* 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA

IG © 2023+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0. Generated 2026-05-10
Links: Table of Contents | QA Report | Version History | | Propose a change