Pharmaceutical Quality (Industry)
1.0.0 - STU1
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
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; Pharmaceutical Plan Type Codes#analytical-procedure "Analytical Procedure")
status: ACTIVE
subject: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
action
title: Preparation and Analysis of Drug Product Samples
participant
typeReference: : Diluent
role: Diluent (Manufacturing Participant Role Codes#diluent)
participant
typeReference: : Resulting material
role: Resulting Material (Manufacturing Participant Role Codes#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 on this page: 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:12e7e672-40a6-4036-3c2f-b8ba6a7d046e
Resource Binary:
Resource Binary "imageResource"
contentType: image/png
data: (base64 data - 3692 bytes)
Entry 7 - fullUrl = urn:uuid:12e7e672-40a6-4036-3c3f-b8ba6a7d046e
Resource Binary:
Resource Binary "imageResource2"
contentType: image/png
data: (base64 data - 3392 bytes)
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-b8ba6a7d046etitle: Identity
status: ACTIVE
code: Identity (Example Local Codes - Drug#IDT "Identification")
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-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 10 - 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 (Product Name Type - example#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 based on FHIR 5.0.0. Generated 2024-05-08
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