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-drug-product-compatibility-pq-ex1 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"
Profile: PlanDefinition - Drug PQ
url:
http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763ftitle: Drug Product Compatibility
type: Workflow Definition (PlanDefinitionType#workflow-definition; CodeSystem - Plan Type#product-compatibility "Product Compatibility")
status: ACTIVE
subject: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)
description: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...
action
title: Results From Evaluation of Drug Product Compatibility With the Glass Syringe Using the Autoinjector/Pen
Actions
Code Definition[x] Test () ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424Test () ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424Test () ObservationDefinition/54bb47fd-8964-4f96-6495-b2bec7f161e8Test () ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958424
Entry 2 - fullUrl = urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd
Resource DiagnosticReport:
Product Compatibility Report
When For 2020-12 Report Details
Code Value When For SE-UHPLC Main Peak (%) 2023-01-01 12:00:00+0000 SE-UHPLC Main Peak (%) 2023-01-01 12:00:00+0000 SE-UHPLC HMW (%) 2023-01-01 12:00:00+0000 SE-UHPLC HMW (%) 2023-01-01 12:00:00+0000 CEX-HPLC Acidic Peak (%) 2023-01-01 12:00:00+0000 CEX-HPLC Acidic Peak (%) 2023-01-01 12:00:00+0000 CEX-HPLC Main Peak (%) 2023-01-01 12:00:00+0000 CEX-HPLC Main Peak (%) 2023-01-01 12:00:00+0000 The samples have been assessed and the conclusion is...
Entry 3 - fullUrl = urn:uuid:64525a3d-5034-448a-9c19-938ce1958424
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "64525a3d-5034-448a-9c19-938ce1958424"
url:
http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424title: SE-UHPLC % Main Peak
status: ACTIVE
code: SE-UHPLC Main Peak (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")
component
code: SE-UHPLC Main Peak - 15 (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak-15)
component
code: SE-UHPLC Main Peak - 25 (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak-25)
Entry 4 - fullUrl = urn:uuid:64525a33-5034-448a-9c19-938ce1958424
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "64525a33-5034-448a-9c19-938ce1958424"
url:
http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424title: SE-UHPLC % HMW
status: ACTIVE
code: SE-UHPLC HMW (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")
component
code: SE-UHPLC HMW - 15 (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW-15)
component
code: SE-UHPLC HMW - 25 (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW-25)
Entry 5 - fullUrl = urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e8
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "54bb47fd-8964-4f96-6495-b2bec7f161e8"
url:
http://example-server.com/fhir/ObservationDefinition/54bb47fd-8964-4f96-6495-b2bec7f161e8title: CEX-HPLC % Acidic Peak
status: ACTIVE
code: CEX-HPLC Acidic Peak (%) (CodeSystem - Example Local Codes - Drug#CEX-HPLCAcidicPeak "CEX-HPLC Acidic Peak")
component
code: CEX-HPLC Acidic Peak - 15 (CodeSystem - Example Local Codes - Drug#CEX-HPLCAcidicPeak-15)
component
code: CEX-HPLC Acidic Peak - 25 (CodeSystem - Example Local Codes - Drug#CEX-HPLCAcidicPeak-25)
Entry 6 - fullUrl = urn:uuid:74525a3d-5034-448a-9c19-938ce1958424
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "74525a3d-5034-448a-9c19-938ce1958424"
url:
http://example-server.com/fhir/ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958424title: CEX-HPLC % Main Peak
status: ACTIVE
code: CEX-HPLC Main Peak (%) (CodeSystem - Example Local Codes - Drug#CEX-HPLCMainPeak "CEX-HPLC Main Peak")
component
code: CEX-HPLC Main Peak - 15 (CodeSystem - Example Local Codes - Drug#CEX-HPLCMainPeak-15)
component
code: CEX-HPLC Main Peak - 25 (CodeSystem - Example Local Codes - Drug#CEX-HPLCMainPeak-25)
Entry 7 - fullUrl = urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "44ba47fd-8964-4f96-6495-b2bec7f161e7"
instantiates: See above (ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC Main Peak (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: SE-UHPLC Main Peak - 15 (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak-15)
value: 8.5 %
component
code: SE-UHPLC Main Peak - 25 (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak-25)
value: 9.5 %
Entry 8 - fullUrl = urn:uuid:54ca47fd-8964-4f96-6495-b2bec7f162e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "54ca47fd-8964-4f96-6495-b2bec7f162e7"
instantiates: See above (ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC Main Peak (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: SE-UHPLC Main Peak - 15 (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak-15)
value: 12.5 %
component
code: SE-UHPLC Main Peak - 25 (CodeSystem - Example Local Codes - Drug#SE-UHPLCMainPeak-25)
value: 13.5 %
Entry 9 - fullUrl = urn:uuid:44ba47fd-8964-4f97-6495-b2bec7f161e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "44ba47fd-8964-4f97-6495-b2bec7f161e7"
instantiates: See above (ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC HMW (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: SE-UHPLC HMW - 15 (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW-15)
value: 73.0 %
component
code: SE-UHPLC HMW - 25 (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW-25)
value: 79.0 %
Entry 10 - fullUrl = urn:uuid:54ca47fd-8964-4f98-6495-b2bec7f162e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "54ca47fd-8964-4f98-6495-b2bec7f162e7"
instantiates: See above (ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424)
status: FINAL
code: SE-UHPLC HMW (%) (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: SE-UHPLC HMW - 15 (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW-15)
value: 74.0 %
component
code: SE-UHPLC HMW - 25 (CodeSystem - Example Local Codes - Drug#SE-UHPLCHMW-25)
value: 78.0 %
Entry 11 - fullUrl = urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "54ba47fd-8964-4f96-6495-b2bec7f161e7"
instantiates: See above (ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958424)
status: FINAL
code: CEX-HPLC Main Peak (%) (CodeSystem - Example Local Codes - Drug#CEX-HPLCMainPeak "CEX-HPLC Main Peak")
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: CEX-HPLC Main Peak - 15 (CodeSystem - Example Local Codes - Drug#CEX-HPLCMainPeak-15)
value: 18.5 %
component
code: CEX-HPLC Main Peak - 25 (CodeSystem - Example Local Codes - Drug#CEX-HPLCMainPeak-25)
value: 19.5 %
Entry 12 - fullUrl = urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "54bb47fd-8964-4f96-6495-b2bec7f161e7"
instantiates: See above (ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958424)
status: FINAL
code: CEX-HPLC Main Peak (%) (CodeSystem - Example Local Codes - Drug#CEX-HPLCMainPeak "CEX-HPLC Main Peak")
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: CEX-HPLC Main Peak - 15 (CodeSystem - Example Local Codes - Drug#CEX-HPLCMainPeak-15)
value: 15.5 %
component
code: CEX-HPLC Main Peak - 25 (CodeSystem - Example Local Codes - Drug#CEX-HPLCMainPeak-25)
value: 16.5 %
Entry 13 - fullUrl = urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "54ba47fd-8964-4f96-6495-b2bec7f161e8"
instantiates: See above (ObservationDefinition/54bb47fd-8964-4f96-6495-b2bec7f161e8)
status: FINAL
code: CEX-HPLC Acidic Peak (%) (CodeSystem - Example Local Codes - Drug#CEX-HPLCAcidicPeak "CEX-HPLC Acidic Peak")
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: CEX-HPLC Acidic Peak (%) (CodeSystem - Example Local Codes - Drug#CEX-HPLCAcidicPeak-15 "CEX-HPLC Acidic Peak - 15")
value: 28.5 %
component
code: CEX-HPLC Acidic Peak (%) (CodeSystem - Example Local Codes - Drug#CEX-HPLCAcidicPeak-25 "CEX-HPLC Acidic Peak - 25")
value: 29.5 %
Entry 14 - fullUrl = urn:uuid:54ba48fd-8964-4f96-6495-b2bec7f161e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "54ba48fd-8964-4f96-6495-b2bec7f161e7"
instantiates: See above (ObservationDefinition/54bb47fd-8964-4f96-6495-b2bec7f161e8)
status: FINAL
code: CEX-HPLC Acidic Peak (%) (CodeSystem - Example Local Codes - Drug#CEX-HPLCAcidicPeak "CEX-HPLC Acidic Peak")
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
component
code: CEX-HPLC Acidic Peak (%) (CodeSystem - Example Local Codes - Drug#CEX-HPLCAcidicPeak-15 "CEX-HPLC Acidic Peak - 15")
value: 28.6 %
component
code: CEX-HPLC Acidic Peak (%) (CodeSystem - Example Local Codes - Drug#CEX-HPLCAcidicPeak-25 "CEX-HPLC Acidic Peak - 25")
value: 29.3 %
Entry 15 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
Resource MedicinalProductDefinition:
Generated Narrative: MedicinalProductDefinition
Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
description: Textual description of the product
Names
ProductName Stelbatolol
Entry 16 - fullUrl = urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51
Resource Medication:
Generated Narrative: Medication
Resource Medication "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
code: ()
Batches
Extension LotNumber 88877
Entry 17 - fullUrl = urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc
Resource Medication:
Generated Narrative: Medication
Resource Medication "a9dfda53-734b-045f-7ae4-94a6281d53bc"
code: ()
Batches
Extension LotNumber 88878
Entry 18 - fullUrl = urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08
Resource Organization:
Generated Narrative: Organization
Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b08"
name: Testing Lab
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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