Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot International flag

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-ballot 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

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

-MeasureDetail[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

-MeasureDetail[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

-MeasureDetail[x]
*Under 200 microns (CodeSystem - Example Local Codes - Drug#particle-size "Particle Size")?-200

actor

Options

-TypeReferenceRole
*See above (DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d)Mixing Vessel (CodeSystem - Equipment Class#mixing-vessel)

actor

Options

-TypeReferenceRole
*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

-TypeResourceReference
*SPECIFICATIONOFSee 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

-TypeResourceReference
*SPECIFICATIONOFSee 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

-TypeResourceReference
*SPECIFICATIONOFSee 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

-NameType
*Rotating Impeller with 1.5mm screenREGISTEREDNAME

Properties

-TypeValue[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

-NameType
*Heated dryerREGISTEREDNAME

Properties

-TypeValue[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

-NameType
*BlenderREGISTEREDNAME

Properties

-TypeValue[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: http://example.org/fhir/identifier/document/FLOW-001

status: CURRENT

type: Process Flow Diagram (CodeSystem - Diagram Type#ProcessFlowDiagram)

content

Attachments

-ContentTypeData
*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

-PartType
*20mgStrength 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: urn:oid:2.16.840.1.113883.4.82/3003040516

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: urn:oid:2.16.840.1.113883.4.82/3010027650

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

-NameType
*Mixing VesselREGISTEREDNAME

Classifications

-Type
*Mixing Vessel (CodeSystem - Device Type#mixing-vessel)

Properties

-TypeValue[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

-NameType
*Receiving TankREGISTEREDNAME

Classifications

-Type
*Receiving Tank (CodeSystem - Device Type#receiving-tank)

Properties

-TypeValue[x]
*Capacity (CodeSystem - Device Property#Capacity)1200 litres