Example: Bundle - Manufacturing, product - Pharmaceutical Quality (Industry) v1.0.0-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

Example Bundle: Example: Bundle - Manufacturing, product

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 above (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-a552-65c169e2265a
title: Process 1.0
type: Workflow Definition (PlanDefinitionType#workflow-definition; CodeSystem - Plan Type#manufacturing-process "Manufacturing Process")
status: ACTIVE
subject: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)
description: Narrative description of manufacturing process (5)
goal
id
goal-control-pH
category: Physical Property (CodeSystem - Test Category#C123456)
description: Controls - pH ()
priority: Critical (CodeSystem - Goal Priority#critical)
Targets
- Measure Detail[x]
* pH must be in range 6.9 to 7.1 (CodeSystem - Example Local Codes - Drug#pH "pH") 6.9-7.1 pH
goal
id
goal-control-water-content
category: Physical Property (CodeSystem - Test Category#C123456)
description: Controls - Water Content ()
priority: Critical (CodeSystem - Goal Priority#critical)
Targets
- Measure Detail[x]
* Under 2% (CodeSystem - Example Local Codes - Drug#WaterContent "Water content") ?-2
goal
id
goal-control-particle-size
category: Physical Property (CodeSystem - Test Category#C123456)
description: Controls - Particle Size ()
priority: Critical (CodeSystem - Goal Priority#critical)
Targets
- Measure Detail[x]
* Under 200 microns (CodeSystem - Example Local Codes - Drug#particle-size "Particle Size") ?-200
actor
Options
- TypeReference Role
* See above (DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d) Mixing Vessel (CodeSystem - Equipment Class#mixing-vessel)
actor
Options
- TypeReference Role
* See above (DeviceDefinition/82a39a18-91cf-b29d-76c1-a9e8bad9494d) Receiving Vessel (CodeSystem - Equipment Class#receiving-vessel)
action
Extension - Process Step Scale PQ: Production Scale (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq code PROD = 'Production Scale', stated as 'Production Scale')
Extension - Process Parameters PQ
url
parameter
value: Capacity (CodeSystem - Process Parameter#Capacity)
url
value
value: 750 litres
Extension - Process Parameters PQ
url
parameter
value: Temperature (CodeSystem - Process Parameter#TEMP)
url
value
value: 150 °C (Details: UCUM code Cel = 'Cel')
prefix: 1
description: Mixing of ingredients
code: Mixing of ingredients (CodeSystem - Manufacturing Step#Mixing of ingredients)
Documentations
- Type ResourceReference
* SPECIFICATIONOF See above (DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee)
goalId: goal-control-pH
participant
typeReference: See above (DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9494d)
role: Blender (CodeSystem - Equipment Class#Blender)
participant
typeReference: : starting material
role: Starting Material (CodeSystem - Manufacturing Participant Role#StartingMaterial)
participant
typeReference: : processing material
role: Processing Material (CodeSystem - Manufacturing Participant Role#ProcessingMaterial)
participant
typeReference: : resulting material
role: Resulting Material (CodeSystem - Manufacturing Participant Role#ResultingMaterial)
action
Extension - Process Step Scale PQ: Production Scale (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq code PROD = 'Production Scale', stated as 'Production Scale')
Extension - Process Parameters PQ
url
parameter
value: Process temperature must be below 40°C (CodeSystem - Process Parameter#TEMP-MAX "Maximum Temperature")
url
value
value: 40 °C (Details: UCUM code Cel = 'Cel')
prefix: 2
description: Drying using a heater
code: Drying (CodeSystem - Manufacturing Step#drying)
Documentations
- Type ResourceReference
* SPECIFICATIONOF See above (DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee)
goalId: goal-control-water-content
participant
typeReference: See above (DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bbd9494c)
role: Dryer (CodeSystem - Equipment Class#Dryer)
participant
typeReference: : starting material
role: Starting Material (CodeSystem - Manufacturing Participant Role#StartingMaterial)
participant
typeReference: : resulting material
role: Resulting Material (CodeSystem - Manufacturing Participant Role#ResultingMaterial)
action
Extension - Process Step Scale PQ: Production Scale (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq code PROD = 'Production Scale', stated as 'Production Scale')
Extension - Process Parameters PQ
url
parameter
value: Rotational Speed (CodeSystem - Process Parameter#ROTATIONSPEED)
url
value
value: 2500 rpm
prefix: 3
description: Particle Size Reduction by using a rotating impeller
code: Particle Size Reduction (CodeSystem - Manufacturing Step#particleSizeReduction)
Documentations
- Type ResourceReference
* SPECIFICATIONOF See above (DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee)
goalId: goal-control-particle-size
participant
typeReference: See above (DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9494c)
role: Compression Milling (CodeSystem - Equipment Class#Compression Milling)
participant
typeReference: : starting material
role: Starting Material (CodeSystem - Manufacturing Participant Role#StartingMaterial)
participant
typeReference: : resulting material
role: Resulting Material (CodeSystem - Manufacturing Participant Role#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 (CodeSystem - Device Property#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 (CodeSystem - Device Property#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 (CodeSystem - Device Property#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: id: FLOW-001
status: CURRENT
type: Process Flow Diagram (CodeSystem - Diagram Type#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 (CodeSystem - Product Name Type#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 above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)
role: Active (Ingredient Role#100000072072)
substance
Codes
- Reference
* See above (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 above (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"
Profile: SubstanceDefinition - Component Substance Drug PQ
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: id: 3003040516
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: id: 3010027650
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 above (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"
Profile: SubstanceDefinition - Component Substance Drug PQ
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 above (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 (CodeSystem - Device Type#mixing-vessel)
Properties
- Type Value[x]
* Capacity (CodeSystem - Device Property#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 (CodeSystem - Device Type#receiving-tank)
Properties
- Type Value[x]
* Capacity (CodeSystem - Device Property#Capacity) 1200 litres