Example: Bundle - Process Validation, substance - Pharmaceutical Quality (Industry) v1.0.0

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, substance

Bundle bundle-product-process-validation-pq-ex2-sub of type collection

Entry 1 - fullUrl = urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f

Resource PlanDefinition:

Generated Narrative: PlanDefinition
Resource PlanDefinition "2038e4c7-22b8-4c56-2d28-6c077648763f"
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: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390
description: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...
action
Extension - Process Step Scale PQ: Production Scale (Details: http://terminology.hl7.org/CodeSystem/manufacturing-step-scale code PROD = 'Production Scale', stated as 'Production Scale')
Extension - Process Parameters PQ
url
parameter
value: Mix speed (Process Parameter Codes#SPEED)
url
value
value: 1500 rpm
prefix: 1
title: Step 1 Yield
description: Description of this step
code: Particle Size Reduction (Manufacturing Step Codes#particleSizeReduction)
participant
typeReference: : Starting material
role: Starting Material (Manufacturing Participant Role Codes#StartingMaterial)
participant
typeReference: : Intermediate material
role: Intermediate Material (Manufacturing Participant Role Codes#IntermediateMaterial)
participant
typeReference: : Resulting material
role: Resulting Material (Manufacturing Participant Role Codes#ResultingMaterial)
Actions
- Code Definition[x]
* Test () http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
action
title: Step 1 In-Process Control Data
code: Step 1 In-Process Control Data (Manufacturing Step Codes#Step1In-ProcessControlData)
Actions
- Code Definition[x]
* Test () http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72
* Test () http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9ff1-91c2-2d16-57cb5b295e72
action
title: Step 1 DS Release Testing Results
code: Step 1 DS Release Testing Results (Manufacturing Step Codes#Step1DSReleaseTestingResults)
Actions
- Code Definition[x]
* Test () http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72
* Test () http://example-server.com/fhir/ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d
* Test () http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e
action
Extension - Process Step Scale PQ: Production Scale (Details: http://terminology.hl7.org/CodeSystem/manufacturing-step-scale code PROD = 'Production Scale', stated as 'Production Scale')
prefix: 2
title: Step 2 Yield
description: Description of this step
code: Drying (Manufacturing Step Codes#drying)
participant
typeReference: : Starting material
role: Starting Material (Manufacturing Participant Role Codes#StartingMaterial)
participant
typeReference: : Intermediate material
role: Intermediate Material (Manufacturing Participant Role Codes#IntermediateMaterial)
participant
typeReference: : Resulting material
role: Resulting Material (Manufacturing Participant Role Codes#ResultingMaterial)
Actions
- Code Definition[x]
* Test () http://example-server.com/fhir/ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72

Entry 2 - fullUrl = urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd

Resource DiagnosticReport:

Process Validation Report
When For 2020-12
Report Details
Code Value When For
Yield (%) 75 % 2023-01-01 12:00:00+0000
Yield (%) 77 % 2023-01-01 12:00:00+0000
Yield (%) 76 % 2023-01-01 12:00:00+0000
ResidualWaterContent (w/w%) 6.9 % 2023-01-01 12:00:00+0000
ResidualWaterContent (w/w%) 7.0 % 2023-01-01 12:00:00+0000
ResidualWaterContent (w/w%) 6.8 % 2023-01-01 12:00:00+0000
Appearance Off-white solid 2023-01-01 12:00:00+0000
Appearance Off-white solid 2023-01-01 12:00:00+0000
Appearance Off-white solid 2023-01-01 12:00:00+0000
ID by HPLC Conforms 2023-01-01 12:00:00+0000
ID by HPLC Conforms 2023-01-01 12:00:00+0000
ID by HPLC Does not conform 2023-01-01 12:00:00+0000
Yield (%) 85 % 2023-01-01 12:00:00+0000
Yield (%) 87 % 2023-01-01 12:00:00+0000
Yield (%) 86 % 2023-01-01 12:00:00+0000
The samples have been assessed and the conclusion is...

Entry 3 - fullUrl = urn:uuid:fc07b5d5-9fe1-92c2-2d06-57cb5b295e72