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

## Manufacturing Process: synthetic data rendering - drug product

The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, section 3.2.P.3 Manufacture, subsection 3.2.P.3.3 Description of Manufacturing Process and Process Controls and subsection 3.2.P.3.4 Controls of Critical Steps and Intermediates.

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-ex1
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
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq
Title: Process 1.0
Description: Narrative description of manufacturing process (5)
Type: Workflow Definition [workflow-definition] (http://terminology.hl7.org/CodeSystem/plan-definition-type), Manufacturing Process [manufacturing-process] (http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type)
Status: active
History: This can be text about the history
Subject
Product [documentation R4 R5 R6]
id: medicinalproductdefinition-drug-product-dxpq-ex1
fullUrl: urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
- Name: Stelbat Tablets, 20mg
Name type: Proprietary [Proprietary] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-pq-example)
Strength name part: 20mg
Description: Textual description of the product
Route of Administration: Oral use [20053000] (http://standardterms.edqm.eu)
Dose Form (combination of all parts): Gastro-resistant tablet [10225000] (http://standardterms.edqm.eu)
Ingredient - Active [100000072072] (http://hl7.org/fhir/ingredient-role)
[documentation R4 R5 R6]
id: productIngredient
fullUrl: urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6
Status: active
Role: Active [100000072072] (http://hl7.org/fhir/ingredient-role)
Substance
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
Found a parent (Ingredient/code, id: productIngredient fullUrl: urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6)
which is linked to this by resource.id
Substance - Stelbatolol [documentation R4 R5 R6]
id: Stelbatolol
fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152
Name: Stelbatolol
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: Stelbatolol 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
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
Actor
Participant
Role: Mixing Vessel [mixing-vessel] (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: mixing-vessel
fullUrl: urn:uuid:82a39a18-91cf-a29d-76c1-a9e8bad9494d
Name: Mixing Vessel (name type: registered-name)
Type: Mixing Vessel [mixing-vessel] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceType-pq-example)
Property
Type: Capacity [Capacity] (http://terminology.hl7.org/CodeSystem/device-property)
Value: 1000 litres
Actor
Participant
Role: Receiving Vessel [receiving-vessel] (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: receiving-tank
fullUrl: urn:uuid:82a39a18-91cf-b29d-76c1-a9e8bad9494d
Name: Receiving Tank (name type: registered-name)
Type: Receiving Tank [receiving-tank] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceType-pq-example)
Property
Type: Capacity [Capacity] (http://terminology.hl7.org/CodeSystem/device-property)
Value: 1200 litres
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-drug-pq-process-flow-diagram
fullUrl: urn:uuid:74d4c070-6596-8252-8ad9-afa515a41feb
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DocumentReference-drug-pq
Identifier: FLOW-001 (http://example.org/fhir/identifier/document)
Status: current
Type: Process Flow Diagram [ProcessFlowDiagram] (http://terminology.hl7.org/CodeSystem/diagram-type)
Content
Content Type: image/x-png
Table 1. List of Equipment

Name / Type | Working Capacity (where appropriate)
--- | ---
Mixing Vessel | Capacity: 1000 litres
Receiving Tank | Capacity: 1200 litres
Blender | Maximum capacity: 1000 litres
Heated dryer | Power: 3 kW
Rotating Impeller with 1.5mm screen | Maximum Speed: 5000 RPM

Table 2. In-Process and Quality Controls

Process Step (name) | Parameter | Acceptance Criteria
--- | --- | ---
Step: 1 | Parameter - Capacity | 750 litres
Step: 1 | Parameter - Temperature | 150 °C [Cel] (http://unitsofmeasure.org)
Step: 1 | Controls - pH | pH must be in range 6.9 to 7.1
Step: 2 | Parameter - Maximum Temperature | 40 °C [Cel] (http://unitsofmeasure.org)
Step: 2 | Controls - Water Content | Under 2%
Step: 3 | Parameter - Rotational Speed | 2500 rpm
Step: 3 | Controls - Particle Size | Under 200 microns

Action - 1 - Mixing of ingredients [Mixing of ingredients] (http://terminology.hl7.org/CodeSystem/manufacturing-step)
Step (prefix): 1
Code: Mixing of ingredients [Mixing of ingredients] (http://terminology.hl7.org/CodeSystem/manufacturing-step)
Description: Mixing of ingredients
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: pH must be in range 6.9 to 7.1
Detail: from 6.9 pH to 7.1 pH
Parameters
Parameter: Capacity [Capacity] (http://terminology.hl7.org/CodeSystem/process-parameter)
Value Quantity: 750 litres
Parameters
Parameter: Temperature [TEMP] (http://terminology.hl7.org/CodeSystem/process-parameter)
Value Quantity: 150 °C [Cel] (http://unitsofmeasure.org)
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
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
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-afa515a41fee
Status: current
Content
url: https://www.accumulus.org/wp-content/uploads/2022/05/Accumulus_Logo_horizontal.png
Participant
Role: Blender [Blender] (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: mixer
fullUrl: urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9494d
Name: Blender (name type: registered-name)
Property
Type: Maximum capacity [Maximum capacity] (http://terminology.hl7.org/CodeSystem/device-property)
Value: 1000 litres
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: Stelbatolol 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
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: processingMaterial fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821155)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: manufacturerProcessingMaterial
fullUrl: urn:uuid:8d61736c-a6e3-8301-659f-17da402e012a
- AAA Pharmaceutical, Inc.
Identifier: 3010027650 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Pharmaceutical, Inc.
Type: Drug Product Manufacture [drug-product-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 681 Main Street, Lumberton, New Jersey, 08048, 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
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 - Stelbatolol Aqueous Solution [documentation R4 R5 R6]
id: StelbatololAqueousSolution
fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821154
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq
Name: Stelbatolol Aqueous Solution
Action - 2 - Drying [drying] (http://terminology.hl7.org/CodeSystem/manufacturing-step)
Step (prefix): 2
Code: Drying [drying] (http://terminology.hl7.org/CodeSystem/manufacturing-step)
Description: Drying using a heater
Scale: Production Scale [PROD] (http://terminology.hl7.org/CodeSystem/manufacturing-step-scale)
Goal (goal-control-water-content)
Description: Controls - Water Content
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: Water content [WaterContent] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Under 2%
Detail: to 2%
Parameters
Parameter: Maximum Temperature [TEMP-MAX] (http://terminology.hl7.org/CodeSystem/process-parameter) - Text: Process temperature must be below 40°C
Value Quantity: 40 °C [Cel] (http://unitsofmeasure.org)
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
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
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-afa515a41fee
Status: current
Content
url: https://www.accumulus.org/wp-content/uploads/2022/05/Accumulus_Logo_horizontal.png
Participant
Role: Dryer [Dryer] (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: dryer
fullUrl: urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bbd9494c
Name: Heated dryer (name type: registered-name)
Property
Type: Power [Power] (http://terminology.hl7.org/CodeSystem/device-property)
Value: 3 kW
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
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 - Stelbatolol Aqueous Solution [documentation R4 R5 R6]
id: StelbatololAqueousSolution
fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821154
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq
Name: Stelbatolol Aqueous Solution
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
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 - Stelbatolol Granules [documentation R4 R5 R6]
id: StelbatololGranules
fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821113
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq
Name: Stelbatolol Granules
Action - 3 - Particle Size Reduction [particleSizeReduction] (http://terminology.hl7.org/CodeSystem/manufacturing-step)
Step (prefix): 3
Code: Particle Size Reduction [particleSizeReduction] (http://terminology.hl7.org/CodeSystem/manufacturing-step)
Description: Particle Size Reduction by using a rotating impeller
Scale: Production Scale [PROD] (http://terminology.hl7.org/CodeSystem/manufacturing-step-scale)
Goal (goal-control-particle-size)
Description: Controls - Particle Size
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: Particle Size [particle-size] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Under 200 microns
Detail: to 200 microns
Parameters
Parameter: Rotational Speed [ROTATIONSPEED] (http://terminology.hl7.org/CodeSystem/process-parameter)
Value Quantity: 2500 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
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
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-afa515a41fee
Status: current
Content
url: https://www.accumulus.org/wp-content/uploads/2022/05/Accumulus_Logo_horizontal.png
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: devicedefinition-drug-pq-ex1
fullUrl: urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9494c
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DeviceDefinition-drug-pq
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
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 - Stelbatolol Granules [documentation R4 R5 R6]
id: StelbatololGranules
fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821113
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq
Name: Stelbatolol Granules
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
Found a parent (Ingredient/code, id: productIngredient fullUrl: urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6)
which is linked to this by resource.id
Substance - Stelbatolol [documentation R4 R5 R6]
id: Stelbatolol
fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152
Name: Stelbatolol
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: Stelbatolol 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
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