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-a552-65c169e2265a title: 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-pH category: 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-content category: 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-size category: 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 parameter value: Capacity (Process Parameter Codes#Capacity) url value value: 750 litres Extension - Process Parameters PQ url parameter value: Temperature (Process Parameter Codes#TEMP) url value value: 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 * specification-of 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 parameter value: Process temperature must be below 40°C (Process Parameter Codes#TEMP-MAX "Maximum Temperature") url value value: 40 °C (Details: UCUM code Cel = 'Cel') prefix: 2 description: Drying using a heater code: Drying (Manufacturing Step Codes#drying) Documentations - Type ResourceReference * specification-of 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 parameter value: Rotational Speed (Process Parameter Codes#ROTATIONSPEED) url value value: 2500 rpm prefix: 3 description: Particle Size Reduction by using a rotating impeller code: Particle Size Reduction (Manufacturing Step Codes#particleSizeReduction) Documentations - Type ResourceReference * specification-of 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)
Narrative description of manufacturing process (5)
Particle Size Reduction by using a rotating impeller
Generated Narrative: DeviceDefinition Resource DeviceDefinition "82a39a18-91cf-a19d-76c1-a9e8bad9494c" DeviceNames - Name Type * Rotating Impeller with 1.5mm screen registered-name Properties - Type Value[x] * Maximum Speed (Device Property Codes#Maximum Speed) 5000 RPM
Generated Narrative: DeviceDefinition Resource DeviceDefinition "82a39a18-91cf-a19d-76c1-a9e8bbd9494c" DeviceNames - Name Type * Heated dryer registered-name Properties - Type Value[x] * Power (Device Property Codes#Power) 3 kW
Generated Narrative: DeviceDefinition Resource DeviceDefinition "82a39a18-91cf-a19d-76c1-a9e8bad9494d" DeviceNames - Name Type * Blender registered-name Properties - Type Value[x] * Maximum capacity (Device Property Codes#Maximum capacity) 1000 litres
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 (Diagram Type Codes#ProcessFlowDiagram) content Attachments - ContentType Data * image/x-png (base64 data - 8838 bytes)
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
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)
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
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821152" manufacturer: See on this page: Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d Names - Name * Stelbatolol
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821113" Profile: SubstanceDefinition - Component Substance Drug PQ Names - Name * Stelbatolol Granules
Generated Narrative: Organization Resource Organization "9fe98cfa-9245-8313-0fc5-d15e613b5d6d" identifier: urn:oid:2.16.840.1.113883.4.82/3003040516 active: 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
Generated Narrative: Organization Resource Organization "8d61736c-a6e3-8301-659f-17da402e012a" identifier: urn:oid:2.16.840.1.113883.4.82/3010027650 active: 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
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821153" manufacturer: See on this page: Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d Names - Name * Stelbatosubstance
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821154" Profile: SubstanceDefinition - Component Substance Drug PQ Names - Name * Stelbatolol Aqueous Solution
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821155" manufacturer: See on this page: Organization/8d61736c-a6e3-8301-659f-17da402e012a Names - Name * Processohol
Generated Narrative: DeviceDefinition Resource DeviceDefinition "82a39a18-91cf-a29d-76c1-a9e8bad9494d" DeviceNames - Name Type * Mixing Vessel registered-name Classifications - Type * Mixing Vessel (Device Type - example#mixing-vessel) Properties - Type Value[x] * Capacity (Device Property Codes#Capacity) 1000 litres
Generated Narrative: DeviceDefinition Resource DeviceDefinition "82a39a18-91cf-b29d-76c1-a9e8bad9494d" DeviceNames - Name Type * Receiving Tank registered-name Classifications - Type * Receiving Tank (Device Type - example#receiving-tank) Properties - Type Value[x] * Capacity (Device Property Codes#Capacity) 1200 litres