Pharmaceutical Quality (Industry)
1.0.0 - STU1 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 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

Manufacturing Process: synthetic data rendering - drug substance

The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, section 3.2.S.2 Manufacture, subsection 3.2.S.2.2 Description of Manufacturing Process and Process Controls.

This is the same data as in the example files here in xml and in json, presented for easier viewing. Hovering on words below will show the corresponding sections of the underlying data.

Bundle [documentation R4 R5 R6]
id: bundle-product-manufacturing-pq-ex2-sub
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-manufacturing-pq
Type: collection
Plan [documentation R4 R5 R6]
id: manufacturingProcess-unlinked
fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a
url (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a
Description: Narrative description of substance manufacturing process
Type: Manufacturing Process [manufacturing-process] (http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type)
Status: active
History: This can be text about the history
Subject
Found a parent (PlanDefinition/subjectReference, id: manufacturingProcess-unlinked fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by resource.id
Substance - Stelbatolol [documentation R4 R5 R6]
id: substance1
fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152
Name: Stelbatolol
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: substance1 fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: startingMaterial fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821153)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: processingMaterial fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821155)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: substance-manufacturer
fullUrl: urn:uuid:9fe98cfa-9245-8313-0fc5-d15e613b5d6d
- AAA Molybdenum Products, Inc.
Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Molybdenum Products, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 7233 W 116th Pl, Ste C, Broomfield, Colorado, 80020, USA
Found a parent (PlanDefinition/valueReference, id: manufacturingProcess-unlinked fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by resource.id
Document [documentation R4 R5 R6]
id: DocumentReference-process-flow-diagram-dxpq-ex1
fullUrl: urn:uuid:74d4c070-6596-8252-8ad9-afa515a41feb
Version: 1
Updated: 2023-01-12 Time: 17:57:08.898+00:00
Source: #n4xHiP0iat7deVDt
Identifier: FLOW-001 (http://example.org/fhir/identifier/document)
Status: current
Type: Process Flow Diagram [ProcessFlowDiagram] (http://terminology.hl7.org/CodeSystem/diagram-type)
Content
url: https://example.org/docStore/flow-001
Action - Overall Process [overall process] (http://terminology.hl7.org/CodeSystem/manufacturing-step) - Text: overall process
Code: Overall Process [overall process] (http://terminology.hl7.org/CodeSystem/manufacturing-step) - Text: overall process
Action - 1 - Particle Size Reduction [particleSizeReduction] (http://terminology.hl7.org/CodeSystem/manufacturing-step)
Step (prefix): 1
Code: Particle Size Reduction [particleSizeReduction] (http://terminology.hl7.org/CodeSystem/manufacturing-step)
Description: Description of this step
Scale: Production Scale [PROD] (http://terminology.hl7.org/CodeSystem/manufacturing-step-scale)
Goal (goal-control-pH)
Description: Controls - pH
Category: Physical Property [C123456] (http://terminology.hl7.org/CodeSystem/pharmaceutical-test-category)
Priority: Critical [critical] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-pq-example)
Target
Measure: pH [pH] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Long description of the acceptance criteria - pH must be in range 6.9 to 7.1
Detail: from 6.9 pH to 7.1 pH
Goal (goal-control-temp)
Description: Controls - Temperature
Category: Physical Property [C123456] (http://terminology.hl7.org/CodeSystem/pharmaceutical-test-category)
Priority: Non-critical [non-critical] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-pq-example)
Target
Measure: Temperature [TEMP] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Long description of the control value - Temperature must be below 150°C
Detail: to 150 °C [Cel] (http://unitsofmeasure.org)
Parameters
Parameter: Mix speed [SPEED] (http://terminology.hl7.org/CodeSystem/process-parameter)
Value Quantity: 1500 rpm
Documentation
Type: specification-of
Found a parent (PlanDefinition/resourceReference, id: manufacturingProcess-unlinked fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by resource.id
Document [documentation R4 R5 R6]
id: DocumentReference-image
fullUrl: urn:uuid:74d4c070-6596-8252-8ad9-afa515a41fef
Status: current
Content
Participant
Role: Compression Milling [Compression Milling] (http://terminology.hl7.org/CodeSystem/pharmaceutical-manufacturing-equipment-class)
Found a parent (PlanDefinition/typeReference, id: manufacturingProcess-unlinked fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by resource.id
Device [documentation R4 R5 R6]
id: impeller
fullUrl: urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9494c
Name: Rotating Impeller with 1.5mm screen (name type: registered-name)
Property
Type: Maximum Speed [Maximum Speed] (http://terminology.hl7.org/CodeSystem/device-property)
Value: 5000 RPM
Participant
Role: Starting Material [StartingMaterial] (http://terminology.hl7.org/CodeSystem/manufacturing-participant-role)
Display: Starting Material
Found a parent (PlanDefinition/valueReference, id: manufacturingProcess-unlinked fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by resource.id
Substance - Stelbatosubstance [documentation R4 R5 R6]
id: startingMaterial
fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821153
Name: Stelbatosubstance
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: substance1 fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: startingMaterial fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821153)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: processingMaterial fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821155)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: substance-manufacturer
fullUrl: urn:uuid:9fe98cfa-9245-8313-0fc5-d15e613b5d6d
- AAA Molybdenum Products, Inc.
Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Molybdenum Products, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 7233 W 116th Pl, Ste C, Broomfield, Colorado, 80020, USA
Participant
Role: Processing Material [ProcessingMaterial] (http://terminology.hl7.org/CodeSystem/manufacturing-participant-role)
Display: Processing Material
Found a parent (PlanDefinition/valueReference, id: manufacturingProcess-unlinked fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by resource.id
Substance - Processohol [documentation R4 R5 R6]
id: processingMaterial
fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821155
Name: Processohol
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: substance1 fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: startingMaterial fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821153)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: processingMaterial fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821155)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: substance-manufacturer
fullUrl: urn:uuid:9fe98cfa-9245-8313-0fc5-d15e613b5d6d
- AAA Molybdenum Products, Inc.
Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Molybdenum Products, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 7233 W 116th Pl, Ste C, Broomfield, Colorado, 80020, USA
Participant
Role: Resulting Material [ResultingMaterial] (http://terminology.hl7.org/CodeSystem/manufacturing-participant-role)
Display: Resulting Material
Found a parent (PlanDefinition/valueReference, id: manufacturingProcess-unlinked fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by resource.id
Substance - Resultothane [documentation R4 R5 R6]
id: resultingMaterial
fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821154
Name: Resultothane