Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
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
Bundle bundle-analytical-procedure-pq-ex1-prod of type collection
Entry 1 - fullUrl = urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f
Resource PlanDefinition:
Generated Narrative: PlanDefinition
Resource PlanDefinition "analyticalProcedure"
url:
http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763ftitle: Analytical Procedure
type: Workflow Definition (PlanDefinitionType#workflow-definition; CodeSystem - Plan Type#analytical-procedure "Analytical Procedure")
status: ACTIVE
subject: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)
action
title: Preparation and Analysis of Drug Product Samples
participant
typeReference: : Diluent
role: Diluent (CodeSystem - Manufacturing Participant Role#diluent)
participant
typeReference: : Resulting material
role: Resulting Material (CodeSystem - Manufacturing Participant Role#ResultingMaterial)
action
action
Entry 2 - fullUrl = urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f81
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "9f69ec9c-5fd1-30d2-0790-9e8035565f81"
Names
Name 0.05 % trifluoroacetic acid (TFA) in 50:50 acetonitrile: water (v/v)
Entry 3 - fullUrl = urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "9f69ec9c-5fd1-30d2-0790-9e8035565f82"
Names
Name Stelbat in Diluent (approximately 0.36 mg/mL)
Entry 4 - 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-b8ba6a7d046etitle: Sample Analysis
status: ACTIVE
description: Number of Injections: 1 of each preparation
code: ()
specimen: See above (SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2)
hasMember:
Entry 5 - fullUrl = urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e
Resource ObservationDefinition:
Determine the amount of Stelbat in each sample replicate as follows:
Where:
A SPL = Area of Stelbat in the sample
ANSR = Average normalized standard response factor of standard injections
DF = Overall sample dilution factor
N = Number of tablets in sample preparation
Determine the % label claim of the sample as follows:
Where:
LC = Label claim (mg/tablet) of tested sample
Entry 6 - 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-b8ba6a7d046etitle: Identity
status: ACTIVE
code: Identity (CodeSystem - Example Local Codes - Drug#IDT "Identification")
QualifiedValues
Extension ,
Entry 7 - 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-08e3fc9646a2status: ACTIVE
description: Number of Preparations: 2 (only 1 is required for identity)
typeTested
preference: PREFERRED
handling
MaxDurations
Value Unit 4 days instruction: at ambient or refrigerated conditions protected from light (may be extended with supporting data)
Entry 8 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
Resource MedicinalProductDefinition:
Generated Narrative: MedicinalProductDefinition
Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
combinedPharmaceuticalDoseForm: Gastro-resistant tablet (standardterms.edqm.eu#10225000)
route: Oral use (standardterms.edqm.eu#20053000)
name
productName: Stelbat Tablets, 20mg
type: Proprietary (CodeSystem - Product Name Type#Proprietary)
Parts
Part Type 20mg Strength part (Product Name Part Type#StrengthPart)
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
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