Generated Narrative: MedicinalProductDefinition medicinalproductdefinition-drug-product-pq-ex1 Profile: MedicinalProductDefinition - Drug Product PQ identifier: http://example.org/identifiers/product/PROD-12345 combinedPharmaceuticalDoseForm: Tablet route: Oral use Names - ProductName Type * Stelbatolol 10mg Tablets Invented Name
Generated Narrative: Ingredient ingredient-drug-pq-ex1 Profile: Ingredient - Drug Pq status: Active role: Active substance Codes - Reference * SubstanceDefinition: status = Active
Generated Narrative: SubstanceDefinition substancedefinition-component-substance-drug-pq-ex1 Profile: SubstanceDefinition - Component Substance Drug PQ status: Active manufacturer: Organization AAA Molybdenum Products, Inc. Names - Name * Stelbatolol Hydrochloride
Generated Narrative: Medication medication-batch-information-drug-pq-ex1 Profile: Medication - Batch Information Drug PQ code: batch Medication Manufacturing Batch url manufacturingDate value: 2020-06 url batchQuantity value: 100100 tablets url batchUtilization value: Production url assignedManufacturer value: Organization AAA Molybdenum Products, Inc. closureSystemDescription: 100 cc HDPE Bottle 2 g desiccant url container Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Designation PQ: Maximum Extension - Batch Number of Vials PQ: 3 Extension - Batch Substance Batch PQ: Substance Extension - Packaging Date PQ: 2020-08 Extension - Packaging Site PQ: Organization AAA Molybdenum Products, Inc. Extension - Actual Yield PQ: 4.81 kg Extension - Actual Yield Unfiltered PQ: 4.91 kg Extension Target Fill Weight PQ: 30 g lotNumber: 33445
Generated Narrative: Substance substance-drug-pq-ex1 Profile: Substance - Drug PQ Medication Manufacturing Batch manufacturingDate: 2019-09-07 batchQuantity: 5 kg batchUtilization: Development assignedManufacturer: Organization AAA Molybdenum Products, Inc. Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Retest Date PQ: 2022-09-08 Extension - Actual Yield PQ: 4.8 kg identifier: CAT1 instance: false Codes - Concept * Substance
Metadata Title DP PROCESS VALIDATION Subject Type MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use Description Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies... Type Workflow Definition Process Validation PlanDefinition Action Title Formulation Buffer Preparation Process Parameter Step Code Formulation Buffer Preparation Process Parameter Step PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step) Title Formulation Buffer Preparation Process Parameter Step Code FormulationBufferPreparationProcessParameterStep PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step) Code Conclusion Definition http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424 PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72 PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73 PlanDefinition Action Title Formulation Buffer Preparation Performance Indicator Results Code Formulation Buffer Preparation Performance Indicator Results PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Performance Indicator Results) Title ??? Code ??? PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-939ce1958424 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958424 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958424 PlanDefinition Action Title Thawing and Formulation Process Parameter Results Code Thawing and Formulation Process Parameter Resultss PlanDefinition Sub-Action (Parent Action Title: Thawing and Formulation Process Parameter Results) Title ??? Code ??? PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/74515a3c-5034-448a-9c19-938ce1958424 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe2-91c2-2d16-47cb5b295e72 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc27b5d5-9fe1-92c2-2d06-47cb5b295e73 PlanDefinition Action Title Thawing and Formulation Performance Indicator Results Code Thawing and Formulation Performance Indicator Results PlanDefinition Sub-Action (Parent Action Title: Thawing and Formulation Performance Indicator Results) Title ??? Code ??? PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-47cb5b295e72 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/74515a3c-5134-448a-9c19-939ce1958424 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b4c-5134-448a-9c19-949ce1958424 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958434 PlanDefinition Action Title Bioburden Reduction Filtration Process Parameter Results Code Bioburden Reduction Filtration Process Parameter Results PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Process Parameter Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434 PlanDefinition Action Title Bioburden Reduction Filtration Performance Indicator Results Code Bioburden Reduction Filtration Performance Indicator Results PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Performance Indicator Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434 PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Performance Indicator Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434 PlanDefinition Action Title Media Challenge Hold Times Code Media Challenge Hold Times PlanDefinition Sub-Action (Parent Action Title: Media Challenge Hold Times) Code Test Definition http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434 PlanDefinition Action Title Media Challenge Results Code Media Challenge Results PlanDefinition Sub-Action (Parent Action Title: Media Challenge Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524 PlanDefinition Sub-Action (Parent Action Title: Media Challenge Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524 PlanDefinition Action Title Filtered Formulated Drug Product Performance Indicator Results Code Filtered Formulated Drug Product Performance Indicator Results PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424 PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424 PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424 PlanDefinition Action Title Fill Weight Summary Code Fill Weight Summary PlanDefinition Sub-Action (Parent Action Title: Fill Weight Summary) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524 PlanDefinition Action Title Filling Homogeneity Quality Attributes Code Filling Homogeneity Quality Attributes PlanDefinition Sub-Action (Parent Action Title: Filling Homogeneity Quality Attributes) Code Conclusion Definition http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424 PlanDefinition Action Title Filling Results Summary Code Filling Results Summary PlanDefinition Sub-Action (Parent Action Title: Filling Results Summary) Code Test Definition http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524 PlanDefinition Sub-Action (Parent Action Title: Filling Results Summary) Code Test Definition http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524 PlanDefinition Action Title Statistical Evaluation of Homogeneity Data Code Statistical Evaluation of Homogeneity Data PlanDefinition Sub-Action (Parent Action Title: Statistical Evaluation of Homogeneity Data) Code Test Definition http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534 PlanDefinition Sub-Action (Parent Action Title: Statistical Evaluation of Homogeneity Data) Code Test Definition http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524 PlanDefinition Action Title Consistency of the Lyophilization Process Code Consistency of the Lyophilization Process PlanDefinition Sub-Action (Parent Action Title: Consistency of the Lyophilization Process) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72 PlanDefinition Sub-Action (Parent Action Title: Consistency of the Lyophilization Process) Code Definition Definition http://example-server.com/fhir/ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bd PlanDefinition Action Title Lyophilization Homogeneity Code Lyophilization Homogeneity Results PlanDefinition Sub-Action (Parent Action Title: Lyophilization Homogeneity) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424 PlanDefinition Sub-Action (Parent Action Title: Lyophilization Homogeneity) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424 Generated using version 0.5.4 of the sample-content-ig Liquid templates
Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...
Formulation Buffer Preparation Process Parameter Step
Formulation Buffer Preparation Performance Indicator Results
Thawing and Formulation Process Parameter Results
Thawing and Formulation Process Parameter Resultss
Thawing and Formulation Performance Indicator Results
Bioburden Reduction Filtration Process Parameter Results
Bioburden Reduction Filtration Performance Indicator Results
Filtered Formulated Drug Product Performance Indicator Results
Statistical Evaluation of Homogeneity Data
Consistency of the Lyophilization Process
Metadata Title Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ. Generated using version 0.5.4 of the sample-content-ig Liquid templates
Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ.
Generated Narrative: ObservationDefinition Assay Profile: ObservationDefinition - Test Method PQ status: Active code: Assay method: Assay by UHPLC
Generated Narrative: DeviceDefinition devicedefinition-drug-pq-ex1 Profile: DeviceDefinition - Drug PQ DeviceNames - Name Type * Rotating Impeller with 1.5mm screen Registered name Properties - Type Value[x] * Maximum Speed 5000 RPM
Generated Narrative: DiagnosticReport diagnosticreport-analysis-drug-pq-stability-prod Profile: DiagnosticReport - Analysis Drug PQ Stability Study Report - 18 months When For 2020-12 Performer Organization AAA Molybdenum Products, Inc. Identifier https://eudract.europa.eu/example/identifier/ABC1234 Report Details Code Value Flags When For Test Components - Long-term 25C etc - Initial (XYZ) Final 2023-01-01 12:00:00+0000 The samples have been assessed for initial period; no shelf life determined.
information about statistical model utilized to interpret stability study results
The samples have been assessed for initial period; no shelf life determined.
Generated Narrative: Procedure procedure-drug-pq-ex1 Profile: Procedure - Drug PQ identifier: Run 1 status: Completed code: Media Challenge Run subject: Drug product
Generated Narrative: Observation observation-test-result-lt25c-i1-degradation-imp-total Profile: Observation - Test Result Drug PQ status: Final code: Degradation Products subject: Medication effective: 2023-01-01 12:00:00+0000 performer: Organization AAA Molybdenum Products, Inc. value: 0.801 % w/w (Details: UCUM code% = '%') Components - Code Value[x] * Impurity Total Degradation Impurities
Generated Narrative: Organization organization-drug-pq-ex1 Profile: Organization - Drug PQ identifier: <a href="http://terminology.hl7.org/7.1.0/NamingSystem-FEI.html" title=""A FDA Establishment Identifier or Firm Establishment Identifier (FEI) is an FDA system generated number used to identify a firm. FDA systems interact, occasionally creating multiple records (FEIs) for one firm. Upon evaluation, these numbers are merged into one surviving FEI which is used to identify the firm. The remaining FEIs become children of the surviving FEI and are not used to identify the firm."#xD;#xA;#xD;#xA;For more information, see [https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=common.faq](https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=common.faq).">FDA Establishment Identifier/3003040516 active: true type: Drug Substance Manufacture name: AAA Molybdenum Products, Inc. Contacts - Address * 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA