Example: Bundle – Analytical Procedure, substance - Pharmaceutical Quality (Industry) v1.0.0-ballot

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

This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Example Bundle: Example: Bundle – Analytical Procedure, substance

Bundle bundle-analytical-procedure-pq-ex2-sub of type collection

Entry 1 - fullUrl = urn:uuid:2138e4c7-22b8-4c56-2d28-6c077648763f

Resource PlanDefinition:

Generated Narrative: PlanDefinition
Resource PlanDefinition "analyticalProcedure"
url: http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f
title: Analytical Procedure
type: Workflow Definition (PlanDefinitionType#workflow-definition; CodeSystem - Plan Type#analytical-procedure "Analytical Procedure")
status: ACTIVE
subject: See above (SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152)
action
Extension - Process Parameters PQ
url
parameter
value: Optical properties (CodeSystem - Process Parameter#OPTICAL)
url
valueText
value: Same as for blue light
Extension - Process Parameters PQ
url
parameter
value: Theory (CodeSystem - Process Parameter#THEORY)
url
valueText
value: MIE
Extension - Process Parameters PQ
url
parameter
value: Stir Time (CodeSystem - Process Parameter#STIR)
url
value
value: 1 minute
title: Determination of Particle Size of Stelbat by Laser Diffraction (G1112)
participant
typeReference: : Dispersant
role: Dispersant (CodeSystem - Manufacturing Participant Role#dispersant)
participant
typeReference: : Resulting material
role: Resulting Material (CodeSystem - Manufacturing Participant Role#ResultingMaterial)
action
action
action
action

Entry 2 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821152"
Names
- Name
* Stelbatolol

Entry 3 - fullUrl = urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8135565f82

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "9f69ec9c-5fd1-30d2-0790-9e8135565f82"
Properties
- Type Value[x]
* Shelf life () Refer to local laboratory expiration date (may be extended with supporting data) ()
Names
- Name
* 0.1% Sorbitan monooleate (Span 80) in hexanes (m/v)

Entry 4 - fullUrl = urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "9f69ec9c-5fd1-30d2-0790-9e8035565f82"
Names
- Name
* Stelbat in dispersant (approximately 10 mg/mL)

Entry 5 - fullUrl = urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "12e7e672-40a6-4136-3c1f-b8ba6a7d046e"
url: http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e
title: Particle Size
status: ACTIVE
description: Number of Analyses: 1 replicate for each sample preparation
code: ()
specimen: See above (SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2)
device: See above (DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9495c)
hasMember:
See above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e)
See above (ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e)
See above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e)

Entry 6 - fullUrl = urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "12e7e672-40a6-4036-3c1f-b8ba6a7d045e"
url: http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e
title: Obscuration
status: ACTIVE
code: Obscuration (%) (CodeSystem - Example Local Codes - Drug#Obscuration "Obscuration")
QualifiedValues
- Range
* 10-30 %

Entry 7 - fullUrl = urn:uuid:12e7e672-41a6-4036-3c1f-b8ba6a7d045e

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "12e7e672-41a6-4036-3c1f-b8ba6a7d045e"
url: http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e
title: Particle refractive index
status: ACTIVE
code: Particle refractive index (CodeSystem - Example Local Codes - Drug#Refractive index "Refractive index")
QualifiedValues
- Range
* 1.75-1.75

Entry 8 - fullUrl = urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "12e7e672-40a6-4036-3c1f-b8ba6a7d046e"
url: http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e
title: Particle Size RSD
status: ACTIVE
code: Particle Size RSD (CodeSystem - Example Local Codes - Drug#Particle Size RSD)
QualifiedValues
- Extension
*

Entry 9 - fullUrl = urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2

Resource SpecimenDefinition:

Generated Narrative: SpecimenDefinition
Resource SpecimenDefinition "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"
url: http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2
status: ACTIVE
description: Number of Preparations: 3

Entry 10 - fullUrl = urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9495c

Resource DeviceDefinition:

Generated Narrative: DeviceDefinition
Resource DeviceDefinition "82a39a18-91cf-a19d-76c1-a9e8bad9495c"
description: Analyzer with disperser and temperature control accessory, or equivalent
Classifications
- Type
* Particle Size Analyzer with Laser Diffraction ()

IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
Links: Table of Contents | QA Report | Version History | | Propose a change