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-product-manufacturing-pq-ex1 of type collection
Entry 1 - fullUrl = urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a
Resource PlanDefinition:
Generated Narrative: PlanDefinition
Resource PlanDefinition "bf6b038b-1334-3dd4-a552-65c169e2265a"
Profile: PlanDefinition - Drug PQ
Extension - Plan Document Reference PQ: See on this page: DocumentReference/74d4c070-6596-8252-8ad9-afa515a41feb
Extension - History of Process PQ: This can be text about the history
url:
http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265atitle: Process 1.0
type: Workflow Definition (PlanDefinitionType#workflow-definition; Pharmaceutical Plan Type Codes#manufacturing-process "Manufacturing Process")
status: ACTIVE
subject: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
description: Narrative description of manufacturing process (5)
goal
id
goal-control-pHcategory: Physical Property (Pharmaceutical Test Category Codes#C123456)
description: Controls - pH ()
priority: Critical (Goal Priority - example#critical)
Targets
Measure Detail[x] pH must be in range 6.9 to 7.1 (Example Local Codes - Drug#pH "pH") 6.9-7.1 pH goal
id
goal-control-water-contentcategory: Physical Property (Pharmaceutical Test Category Codes#C123456)
description: Controls - Water Content ()
priority: Critical (Goal Priority - example#critical)
Targets
Measure Detail[x] Under 2% (Example Local Codes - Drug#WaterContent "Water content") ?-2 goal
id
goal-control-particle-sizecategory: Physical Property (Pharmaceutical Test Category Codes#C123456)
description: Controls - Particle Size ()
priority: Critical (Goal Priority - example#critical)
Targets
Measure Detail[x] Under 200 microns (Example Local Codes - Drug#particle-size "Particle Size") ?-200 actor
Options
TypeReference Role See on this page: DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d Mixing Vessel (Pharmaceutical Manufacturing Equipment Class Codes#mixing-vessel) actor
Options
TypeReference Role See on this page: DeviceDefinition/82a39a18-91cf-b29d-76c1-a9e8bad9494d Receiving Vessel (Pharmaceutical Manufacturing Equipment Class Codes#receiving-vessel) 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
parametervalue: Capacity (Process Parameter Codes#Capacity)
url
valuevalue: 750 litres
Extension - Process Parameters PQ
url
parametervalue: Temperature (Process Parameter Codes#TEMP)
url
valuevalue: 150 °C (Details: UCUM code Cel = 'Cel')
prefix: 1
description: Mixing of ingredients
code: Mixing of ingredients (Manufacturing Step Codes#Mixing of ingredients)
Documentations
Type ResourceReference SPECIFICATIONOF See on this page: DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee goalId: goal-control-pH
participant
typeReference: See on this page: DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9494d
role: Blender (Pharmaceutical Manufacturing Equipment Class Codes#Blender)
participant
typeReference: : starting material
role: Starting Material (Manufacturing Participant Role Codes#StartingMaterial)
participant
typeReference: : processing material
role: Processing Material (Manufacturing Participant Role Codes#ProcessingMaterial)
participant
typeReference: : resulting material
role: Resulting Material (Manufacturing Participant Role Codes#ResultingMaterial)
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
parametervalue: Process temperature must be below 40°C (Process Parameter Codes#TEMP-MAX "Maximum Temperature")
url
valuevalue: 40 °C (Details: UCUM code Cel = 'Cel')
prefix: 2
description: Drying using a heater
code: Drying (Manufacturing Step Codes#drying)
Documentations
Type ResourceReference SPECIFICATIONOF See on this page: DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee goalId: goal-control-water-content
participant
typeReference: See on this page: DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bbd9494c
role: Dryer (Pharmaceutical Manufacturing Equipment Class Codes#Dryer)
participant
typeReference: : starting material
role: Starting Material (Manufacturing Participant Role Codes#StartingMaterial)
participant
typeReference: : resulting material
role: Resulting Material (Manufacturing Participant Role Codes#ResultingMaterial)
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
parametervalue: Rotational Speed (Process Parameter Codes#ROTATIONSPEED)
url
valuevalue: 2500 rpm
prefix: 3
description: Particle Size Reduction by using a rotating impeller
code: Particle Size Reduction (Manufacturing Step Codes#particleSizeReduction)
Documentations
Type ResourceReference SPECIFICATIONOF See on this page: DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee goalId: goal-control-particle-size
participant
typeReference: See on this page: DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9494c
role: Compression Milling (Pharmaceutical Manufacturing Equipment Class Codes#Compression Milling)
participant
typeReference: : starting material
role: Starting Material (Manufacturing Participant Role Codes#StartingMaterial)
participant
typeReference: : resulting material
role: Resulting Material (Manufacturing Participant Role Codes#ResultingMaterial)
Entry 2 - fullUrl = urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9494c
Resource DeviceDefinition:
Generated Narrative: DeviceDefinition
Resource DeviceDefinition "82a39a18-91cf-a19d-76c1-a9e8bad9494c"
DeviceNames
Name Type Rotating Impeller with 1.5mm screen REGISTEREDNAME Properties
Type Value[x] Maximum Speed (Device Property Codes#Maximum Speed) 5000 RPM
Entry 3 - fullUrl = urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bbd9494c
Resource DeviceDefinition:
Generated Narrative: DeviceDefinition
Resource DeviceDefinition "82a39a18-91cf-a19d-76c1-a9e8bbd9494c"
DeviceNames
Name Type Heated dryer REGISTEREDNAME Properties
Type Value[x] Power (Device Property Codes#Power) 3 kW
Entry 4 - fullUrl = urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9494d
Resource DeviceDefinition:
Generated Narrative: DeviceDefinition
Resource DeviceDefinition "82a39a18-91cf-a19d-76c1-a9e8bad9494d"
DeviceNames
Name Type Blender REGISTEREDNAME Properties
Type Value[x] Maximum capacity (Device Property Codes#Maximum capacity) 1000 litres
Entry 5 - fullUrl = urn:uuid:74d4c070-6596-8252-8ad9-afa515a41feb
Resource DocumentReference:
Generated Narrative: DocumentReference
Resource DocumentReference "74d4c070-6596-8252-8ad9-afa515a41feb"
identifier:
http://example.org/fhir/identifier/document/FLOW-001status: CURRENT
type: Process Flow Diagram (Diagram Type Codes#ProcessFlowDiagram)
content
Attachments
ContentType Data image/x-png (base64 data - 8838 bytes)
Entry 6 - fullUrl = urn:uuid:74d4c070-6596-8252-8ad9-afa515a41fee
Resource DocumentReference:
Generated Narrative: DocumentReference
Resource DocumentReference "74d4c070-6596-8252-8ad9-afa515a41fee"
status: CURRENT
content
Attachments
Url https://www.accumulus.org/wp-content/uploads/2022/05/Accumulus_Logo_horizontal.png
Entry 7 - 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
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)
Entry 8 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6
Resource Ingredient:
Generated Narrative: Ingredient
Resource Ingredient "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6"
status: ACTIVE
for: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
role: Active (Ingredient Role#100000072072)
substance
Codes
Reference See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152
Entry 9 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821152"
manufacturer: See on this page: Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d
Names
Name Stelbatolol
Entry 10 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821113
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821113"
Names
Name Stelbatolol Granules
Entry 11 - fullUrl = urn:uuid:9fe98cfa-9245-8313-0fc5-d15e613b5d6d
Resource Organization:
Generated Narrative: Organization
Resource Organization "9fe98cfa-9245-8313-0fc5-d15e613b5d6d"
identifier:
urn:oid:2.16.840.1.113883.4.82/3003040516active: true
type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#drug-substance-manufacture)
name: AAA Molybdenum Products, Inc.
Contacts
Address 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA
Entry 12 - fullUrl = urn:uuid:8d61736c-a6e3-8301-659f-17da402e012a
Resource Organization:
Generated Narrative: Organization
Resource Organization "8d61736c-a6e3-8301-659f-17da402e012a"
identifier:
urn:oid:2.16.840.1.113883.4.82/3010027650active: true
type: Drug Product Manufacture (Pharmaceutical Organization Type Codes#drug-product-manufacture)
name: AAA Pharmaceutical, Inc.
Contacts
Address 681 Main Street Lumberton New Jersey 08048 USA
Entry 13 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821153
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821153"
manufacturer: See on this page: Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d
Names
Name Stelbatosubstance
Entry 14 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821154
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821154"
Names
Name Stelbatolol Aqueous Solution
Entry 15 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821155
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821155"
manufacturer: See on this page: Organization/8d61736c-a6e3-8301-659f-17da402e012a
Names
Name Processohol
Entry 16 - fullUrl = urn:uuid:82a39a18-91cf-a29d-76c1-a9e8bad9494d
Resource DeviceDefinition:
Generated Narrative: DeviceDefinition
Resource DeviceDefinition "82a39a18-91cf-a29d-76c1-a9e8bad9494d"
DeviceNames
Name Type Mixing Vessel REGISTEREDNAME Classifications
Type Mixing Vessel (Device Type - example#mixing-vessel) Properties
Type Value[x] Capacity (Device Property Codes#Capacity) 1000 litres
Entry 17 - fullUrl = urn:uuid:82a39a18-91cf-b29d-76c1-a9e8bad9494d
Resource DeviceDefinition:
Generated Narrative: DeviceDefinition
Resource DeviceDefinition "82a39a18-91cf-b29d-76c1-a9e8bad9494d"
DeviceNames
Name Type Receiving Tank REGISTEREDNAME Classifications
Type Receiving Tank (Device Type - example#receiving-tank) Properties
Type Value[x] Capacity (Device Property Codes#Capacity) 1200 litres
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
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change
