Generated Narrative: PlanDefinition Resource PlanDefinition "2038e4c7-22b8-4c56-2d28-6c077648763f" url: http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f title: DP PROCESS VALIDATION type: Workflow Definition (PlanDefinitionType#workflow-definition; Pharmaceutical Plan Type Codes#process-validation "Process Validation") status: active subject: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5 description: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies... action title: Compounding Step code: Compounding Step (Manufacturing Step Codes#compounding) action title: Compounding Steps code: Compounding () action action action action action title: Filling Steps code: Filling Step (Manufacturing Step Codes#filling) action title: ??? code: ??? () action action action action action action action action action action title: Lyophilization Step code: Lyophilization Step (Manufacturing Step Codes#lyophilization) Actions - Code Definition[x] * Conclusion () http://example-server.com/fhir/ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424 * Test () http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424 * Test () http://example-server.com/fhir/ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e * Test () http://example-server.com/fhir/ObservationDefinition/32e29d22-5fcb-546e-24fd-52a4a4004467 * Homogeneity () http://example-server.com/fhir/ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467 * Homogeneity () http://example-server.com/fhir/ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467 action title: Release Step code: Release Step (Manufacturing Step Codes#release) action title: ??? code: ??? () action action action action action action action action action action
Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...
Generated Narrative: ObservationDefinition Resource ObservationDefinition "fc17b5d5-9fe1-91c2-2d06-47cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72 title: pH (adjustment of pre-clarification bulk solution) status: active code: pH (adjustment of pre-clarification bulk solution) (Example Local Codes - Drug#pH (adjustment of pre-clarification bulk solution)) QualifiedValues - Range * 6.9-7.1 pH
pH (adjustment of pre-clarification bulk solution)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "fc17b5d5-9fe1-91c2-2d06-47cb5b295e73" url: http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73 title: pH (post-dilution bulk solution) status: active code: pH (post-dilution bulk solution) (Example Local Codes - Drug#pH (post-dilution bulk solution)) QualifiedValues - Range * 7.0-7.1 pH
Generated Narrative: ObservationDefinition Resource ObservationDefinition "fd17b5d5-9fe1-91c2-2d06-47cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72 title: Assay (pre-clarification filtration) (mg/mL) status: active code: Assay (pre-clarification filtration) (mg/mL) (Example Local Codes - Drug#Assay (pre-clarification filtration) (mg/mL)) QualifiedValues - Range * 22-? mg/mL
Assay (pre-clarification filtration) (mg/mL)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "fd17b5d5-9fe1-91c2-2d06-47cb5b295e73" url: http://example-server.com/fhir/ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73 title: Assay (Post dilution bulk solution) (mg/mL) status: active code: Assay (Post dilution bulk solution) (mg/mL) (Example Local Codes - Drug#Assay (Post dilution bulk solution) (mg/mL)) QualifiedValues - Range * 20-21 mg/mL
Assay (Post dilution bulk solution) (mg/mL)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "fc07b5d5-9fe1-92c2-2d06-47cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-47cb5b295e72 title: Appearance (Product Container, visual) status: active code: Appearance (Product Container, visual) (Example Local Codes - Drug#Appearance (Product Container, visual)) method: Visual inspection () QualifiedValues - Extension *
1) Clear glass vial sealed with a gray rubber stopper and a flip off overseal 2) No visible damage or breach of vial container or closure
Generated Narrative: ObservationDefinition Resource ObservationDefinition "fc07b5d5-9fe1-92c3-2d16-47cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c3-2d16-47cb5b295e72 title: Appearance (Lyophilized, Visual) status: active code: Appearance (Lyophilized, Visual) (Example Local Codes - Drug#Appearance (Lyophilized, Visual)) method: Visual inspection () QualifiedValues - Extension *
White to off white cake or powder, essentially free from evidence of contamination with no visible foreign particulates
Generated Narrative: ObservationDefinition Resource ObservationDefinition "fc07b5d5-9fe1-92c3-2d06-47cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c3-2d06-47cb5b295e72 title: Appearance (Reconstituted, Visual) status: active code: Appearance (Reconstituted, Visual) (Example Local Codes - Drug#Appearance (Reconstituted, Visual)) method: Visual inspection () QualifiedValues - Extension *
Clear, colorless to slightly yellow solution, essentially free of visible particulates
Generated Narrative: ObservationDefinition Resource ObservationDefinition "3b0e878e-4bc9-8864-862f-e28b21233e8d" url: http://example-server.com/fhir/ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d title: Identification status: active code: Identification (Example Local Codes - Drug#IDT) method: ID by UHPLC () QualifiedValues - Extension *
Consistent with the retention time and UV spectrum of the reference standard
Generated Narrative: ObservationDefinition Resource ObservationDefinition "12e7e672-40a6-4036-3c1f-b8ba6a7d045e" url: http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e title: Assay status: active code: Assay (Example Local Codes - Drug#ASSAY) method: Assay by UHPLC () QualifiedValues - Extension *
Generated Narrative: ObservationDefinition Resource ObservationDefinition "8bdea820-4197-7c7d-0990-7be06bf78aaf" url: http://example-server.com/fhir/ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf title: Degradation Products status: active code: Degradation Products (Example Local Codes - Drug#DGP) method: Degradation products by UHPLC () qualifiedValue appliesTo: Impurity 1 () range: ?-0.2 qualifiedValue appliesTo: Impurity 2 () range: ?-0.3 qualifiedValue appliesTo: Impurity 3 () range: ?-0.3 qualifiedValue appliesTo: Individual unspecified degradation products () range: ?-0.2 qualifiedValue appliesTo: Total degradation products () range: ?-1.4 Components - Code * Impurity (Example Local Codes - Drug#IMP)
Individual unspecified degradation products
Generated Narrative: ObservationDefinition Resource ObservationDefinition "31e29d22-5fcb-546e-24fd-52a4a4004467" url: http://example-server.com/fhir/ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467 title: Water Content status: active code: Water Content (Example Local Codes - Drug#WaterContent) method: USP <921> () QualifiedValues - Range * ?-1.0
Generated Narrative: ObservationDefinition Resource ObservationDefinition "32e29d22-5fcb-546e-24fd-52a4a4004467" url: http://example-server.com/fhir/ObservationDefinition/32e29d22-5fcb-546e-24fd-52a4a4004467 title: Water Content status: active code: Water Content (Example Local Codes - Drug#WaterContent) method: USP <921> () QualifiedValues - Range * ?-1.2
Generated Narrative: ObservationDefinition Resource ObservationDefinition "32e29d22-6fcb-546e-24fd-52a4a4004467" url: http://example-server.com/fhir/ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467 title: Water Content status: active code: Moisture (%) (Example Local Codes - Drug#WWWH "Water Content Homogeneity") QualifiedValues - Extension Range * -1.5-1.5 % w/w component code: Do statistically significant effects (Example Local Codes - Drug#SSE "Statistically significant effects") component code: Lower one-sided 95% confidence limit of Max Difference (Example Local Codes - Drug#LCL) component code: Upper one-sided 95% confidence limit of Max Difference (Example Local Codes - Drug#UCL) component code: Was Homogeneity demonstrated? (Example Local Codes - Drug#Homogeneity "Homogeneity demonstrated")
Lower one-sided 95% confidence limit of Max Difference
Upper one-sided 95% confidence limit of Max Difference
Generated Narrative: ObservationDefinition Resource ObservationDefinition "32e29d32-6fcb-546e-24fd-52a4a4004467" url: http://example-server.com/fhir/ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467 title: Assay status: active code: Assay by HPLC (% Main Peak) (Example Local Codes - Drug#ASSH "Assay Content Homogeneity") QualifiedValues - Extension Range * -2.3-2.3 % component code: Do statistically significant effects (Example Local Codes - Drug#SSE "Statistically significant effects") component code: Lower one-sided 95% confidence limit of Max Difference (Example Local Codes - Drug#LCL) component code: Upper one-sided 95% confidence limit of Max Difference (Example Local Codes - Drug#UCL) component code: Was Homogeneity demonstrated? (Example Local Codes - Drug#Homogeneity "Homogeneity demonstrated")
Generated Narrative: ObservationDefinition Resource ObservationDefinition "ef17cff1-6586-a5a4-9168-2602140548d7" url: http://example-server.com/fhir/ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d7 title: Uniformity of Dosage Units, Weight Variation - Meets USP / Ph. Eur. requirements (% label claim) status: active code: Uniformity of Dosage Units, Weight Variation (Example Local Codes - Drug#Uniformity of Dosage Units, Weight Variation) method: Weight variation () QualifiedValues - Range * 97-? %
Uniformity of Dosage Units, Weight Variation - Meets USP / Ph. Eur. requirements (% label claim)
Uniformity of Dosage Units, Weight Variation
Generated Narrative: ObservationDefinition Resource ObservationDefinition "ef17cff1-6586-a5a4-9168-2602140548d8" url: http://example-server.com/fhir/ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d8 title: Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV) status: active code: Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV) (Example Local Codes - Drug#Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)) method: Weight variation () QualifiedValues - Range * ?-25
Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "fc17b5d6-9fe1-91c2-2d06-47cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d06-47cb5b295e72 title: pH (reconstituted) status: active code: pH (reconstituted) (Example Local Codes - Drug#pH (reconstituted)) QualifiedValues - Range * 6.95-7.05 pH
Generated Narrative: ObservationDefinition Resource ObservationDefinition "22515a3c-5034-448a-9c19-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424 title: Conclusion status: active code: Conclusion (Example Local Codes - Drug#CONC)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64505a3c-5034-448a-9c19-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64505a3c-5034-448a-9c19-938ce1958424 title: TAMC [a] status: active code: TAMC (Example Local Codes - Drug#TAMC) QualifiedValues - Range * ?-10
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64515a3c-5034-448a-9c19-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424 title: TYMC [a] status: active code: TAMC (Example Local Codes - Drug#TAMC) QualifiedValues - Range * ?-10
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64515a3c-5134-448a-9c19-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-938ce1958424 title: Fill Weight Average status: active code: Fill Weight Average (Example Local Codes - Drug#Fill Weight Average) QualifiedValues - Extension *
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64525a3c-5134-448a-9c19-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64525a3c-5134-448a-9c19-938ce1958424 title: Fill Weight Target status: active code: Fill Weight Target (g) (Example Local Codes - Drug#Fill Weight Target (g)) QualifiedValues - Extension *
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64515a3c-5134-448a-9c29-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c29-938ce1958424 title: Actual Avg. Weight from Target status: active code: Actual Avg. Weight from Target (Example Local Codes - Drug#Actual Avg. Weight from Target) QualifiedValues - Extension Range * 2-2 %
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64515a3c-5234-448a-9c29-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64515a3c-5234-448a-9c29-938ce1958424 title: Hold Time (filtration To filling) status: active code: Hold Time (filtration To filling) (Example Local Codes - Drug#Hold Time (filtration To filling)) QualifiedValues - Range * ?-2.5
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64515a3c-5334-448a-9c29-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64515a3c-5334-448a-9c29-938ce1958424 title: Hold Time (start filling to end filling) status: active code: Hold Time (start filling to end filling) (Example Local Codes - Drug#Hold Time (start filling to end filling)) QualifiedValues - Range * ?-1.25
Hold Time (start filling to end filling)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64535a3c-5334-448a-9c29-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce1958424 title: Filter Integrity Test status: active code: Filter Integrity Test (Example Local Codes - Drug#Filter Integrity Test) QualifiedValues - Range * 3.5-? psi
Generated Narrative: ObservationDefinition Resource ObservationDefinition "22525a3c-5034-448a-9c19-938ce1958424" url: http://example-server.com/fhir/ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424 title: Conclusion status: active code: Conclusion (Example Local Codes - Drug#CONC)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "64535a3c-5334-448a-9c29-938ce2958424" url: http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424 title: Lyophilizer Number status: active code: Lyophilizer Number (Example Local Codes - Drug#Lyophilizer Number)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "22e7e672-40a6-4036-3c1f-b8ba6a7d045e" url: http://example-server.com/fhir/ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e title: Assay status: active code: Assay (Example Local Codes - Drug#ASSAY) method: Assay by UHPLC () QualifiedValues - Extension Range * 95-105 % Components - Code * Number of Locations (Example Local Codes - Drug#LOC)
Generated Narrative: Medication Resource Medication "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51" Profile: Medication - Batch Information Drug PQ code: () Batches - Extension LotNumber * , , , , , , , , , 33445
Generated Narrative: Medication Resource Medication "a9dfda53-734b-045f-7ae4-94a6281d53bc" code: () Batches - Extension LotNumber * , , , , , , , , , 33446
Generated Narrative: Medication Resource Medication "c6f5fadd-62e6-3a01-93d9-b3b182f67d06" code: () Batches - Extension LotNumber * , , , , , , , , , 33447
Generated Narrative: Organization Resource Organization "0102bca4-46c1-a6bf-1025-cd403fee710a" 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: Organization Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b07" identifier: urn:oid:2.16.840.1.113883.4.82/3008816891 active: true type: Packaging (Pharmaceutical Organization Type Codes#packaging) name: MySite
Generated Narrative: Organization Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b08" identifier: urn:oid:2.16.840.1.113883.4.82/3007270600 active: true type: Analytical Testing - Release (Pharmaceutical Organization Type Codes#analytical-testing-release) name: Testing Lab
Generated Narrative: DiagnosticReport Resource DiagnosticReport "processValidationReport" Triggered by: See on this page: PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f status: final code: Process Validation Report (Pharmaceutical Report Type Codes#Process Validation Report) effective: 2020-12 result: See on this page: Observation/9c56948a-2a39-6609-1c01-4d197ea57a33 See on this page: Observation/9c56948a-3a39-6609-1c01-4d197ea57a33 See on this page: Observation/9c56948a-4a39-6609-1c01-4d197ea57a33 See on this page: Observation/9c56948a-3a49-6609-1c01-4d197ea57a33 See on this page: Observation/9c56958a-4a39-6609-1c01-4d197ea57a33 See on this page: Observation/9c56948a-5a39-6609-1c01-4d197ea57a33 See on this page: Observation/9c56948a-2a39-6609-1c01-4d297ea57a33 See on this page: Observation/9c56948a-3a39-6619-1c01-4d197ea57a33 See on this page: Observation/9c56948a-4a39-6619-1c01-4d197ea57a33 See on this page: Observation/9c56948a-3a49-6619-1c01-4d197ea57a33 See on this page: Observation/9c56958a-4a39-6619-1c01-4d197ea57a33 See on this page: Observation/9c56948a-5a39-6709-1c01-4d197ea57a33 See on this page: Observation/f0a04328-905c-4ec5-372e-4d6cfef18629 See on this page: Observation/5e5a5e67-7fc6-0064-1be9-5d9d14d887e5 See on this page: Observation/cfde6776-673c-72e2-68c4-07b77cd85b74 See on this page: Observation/9c56948a-1a39-6609-1c01-4d197ea57a33 See on this page: Observation/1e20aed7-7626-1664-8d96-235f860d9a2c See on this page: Observation/ec6d7e30-4d70-491b-0669-a613eedd3c60 See on this page: Observation/ab7997fa-7b46-1175-3f01-6f6997f7878a See on this page: Observation/4052f28b-64a2-392d-35e4-ec8e912434d2 See on this page: Observation/34ebc51d-8105-0589-3c8d-e7aa6bd0a06c See on this page: Observation/2940bf11-05bf-6ce2-3c64-457d0d1f9913 See on this page: Observation/332b1e76-6f70-2b4e-5d0c-f22a0e042d3e See on this page: Observation/f0a13a3b-2e8b-594f-6874-6050511e4c57 See on this page: Observation/7fe7ccd7-6449-0186-2282-3eeb4cf6a795 See on this page: Observation/be016630-8754-7414-9014-21e020ad66c6 See on this page: Observation/92568f68-78f3-908c-6935-ff5f3d574dd6 See on this page: Observation/a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12 See on this page: Observation/d8533dcb-03f8-5997-6ccf-4f9b6f7a5745 See on this page: Observation/7cec19a2-34a7-6b80-3d60-083b2cc64fcb See on this page: Observation/27aa47fd-7964-4f96-6495-b2bec7f160e7 See on this page: Observation/6a78bcde-4781-226c-946e-a4b6915c1899 See on this page: Observation/f9f11088-7527-947c-3d3f-e71b32e13c78 See on this page: Observation/66c2f585-678e-78b8-2235-1a3b37bd6e46 See on this page: Observation/f8232d25-023d-679f-9c58-a6dc234b7a28 See on this page: Observation/368b82be-75dd-1d97-3dbc-a7eed9869daa See on this page: Observation/44aa47fd-8964-4f96-6495-b2bec7f160e7 See on this page: Observation/45aa47fd-8964-4f96-6495-b2bec7f160e7 See on this page: Observation/45ab47fd-8964-4f96-6495-b2bec7f160e7 See on this page: Observation/37aa47fd-8964-4f96-6495-b2bec7f160e7 See on this page: Observation/38aa47fd-8964-4f96-6495-b2bec7f160e7 See on this page: Observation/38aa48fd-8964-4f96-6495-b2bec7f160e7 See on this page: Observation/37aa47fd-7964-4f96-6495-b2bec7f160e7 See on this page: Observation/47aa47fd-7964-4f96-6495-b2bec7f160e7 See on this page: Observation/47aa47fd-7964-4f96-6495-b2bec7f160e8 See on this page: Observation/47aa47fd-8964-4f96-6495-b2bec7f160e7 See on this page: Observation/47aa47fd-8964-5f96-6495-b2bec7f160e7 conclusion: The samples have been assessed and the conclusion is...
The samples have been assessed and the conclusion is...
Generated Narrative: Observation Resource Observation "f0a04328-905c-4ec5-372e-4d6cfef18629" instantiates: See on this page: ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Observation Resource Observation "5e5a5e67-7fc6-0064-1be9-5d9d14d887e5" instantiates: See on this page: ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Does not comply ()
Generated Narrative: Observation Resource Observation "cfde6776-673c-72e2-68c4-07b77cd85b74" instantiates: See on this page: ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Observation Resource Observation "9c56948a-2a39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72 status: final code: pH (adjustment of pre-clarification bulk solution) (Example Local Codes - Drug#pH (adjustment of pre-clarification bulk solution)) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 6.91 pH (Details: UCUM code pH = 'pH')
Generated Narrative: Observation Resource Observation "9c56948a-3a39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72 status: final code: pH (adjustment of pre-clarification bulk solution) (Example Local Codes - Drug#pH (adjustment of pre-clarification bulk solution)) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 6.92 pH (Details: UCUM code pH = 'pH')
Generated Narrative: Observation Resource Observation "9c56948a-4a39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72 status: final code: pH (adjustment of pre-clarification bulk solution) (Example Local Codes - Drug#pH (adjustment of pre-clarification bulk solution)) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 6.93 pH (Details: UCUM code pH = 'pH')
Generated Narrative: Observation Resource Observation "9c56948a-3a49-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73 status: final code: pH (adjustment of pre-clarification bulk solution) (Example Local Codes - Drug#pH (adjustment of pre-clarification bulk solution)) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 7.01 pH (Details: UCUM code pH = 'pH')
Generated Narrative: Observation Resource Observation "9c56958a-4a39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73 status: final code: pH (adjustment of pre-clarification bulk solution) (Example Local Codes - Drug#pH (adjustment of pre-clarification bulk solution)) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 7.02 pH (Details: UCUM code pH = 'pH')
Generated Narrative: Observation Resource Observation "9c56948a-5a39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73 status: final code: pH (adjustment of pre-clarification bulk solution) (Example Local Codes - Drug#pH (adjustment of pre-clarification bulk solution)) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 6.93 pH (Details: UCUM code pH = 'pH')
Generated Narrative: Observation Resource Observation "9c56948a-2a39-6609-1c01-4d297ea57a33" instantiates: See on this page: ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72 status: final code: Assay (pre-clarification filtration) (mg/mL) (Example Local Codes - Drug#Assay (pre-clarification filtration) (mg/mL)) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 21.1 mg/mL (Details: UCUM code mg/mL = 'mg/mL')
Generated Narrative: Observation Resource Observation "9c56948a-3a39-6619-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72 status: final code: Assay (pre-clarification filtration) (mg/mL) (Example Local Codes - Drug#Assay (pre-clarification filtration) (mg/mL)) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 21.2 mg/mL (Details: UCUM code mg/mL = 'mg/mL')
Generated Narrative: Observation Resource Observation "9c56948a-4a39-6619-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72 status: final code: Assay (pre-clarification filtration) (mg/mL) (Example Local Codes - Drug#Assay (pre-clarification filtration) (mg/mL)) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 21.3 mg/mL (Details: UCUM code mg/mL = 'mg/mL')
Generated Narrative: Observation Resource Observation "9c56948a-3a49-6619-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73 status: final code: Assay (Post dilution bulk solution) (mg/mL) (Example Local Codes - Drug#Assay (Post dilution bulk solution) (mg/mL)) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 20.1 mg/mL (Details: UCUM code mg/mL = 'mg/mL')
Generated Narrative: Observation Resource Observation "9c56958a-4a39-6619-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73 status: final code: Assay (Post dilution bulk solution) (mg/mL) (Example Local Codes - Drug#Assay (Post dilution bulk solution) (mg/mL)) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 20.2 mg/mL (Details: UCUM code mg/mL = 'mg/mL')
Generated Narrative: Observation Resource Observation "9c56948a-5a39-6709-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73 status: final code: Assay (Post dilution bulk solution) (mg/mL) (Example Local Codes - Drug#Assay (Post dilution bulk solution) (mg/mL)) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 20.3 mg/mL (Details: UCUM code mg/mL = 'mg/mL')
Generated Narrative: Observation Resource Observation "9c56948a-1a39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 103 % (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "1e20aed7-7626-1664-8d96-235f860d9a2c" instantiates: See on this page: ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 102 % (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "ec6d7e30-4d70-491b-0669-a613eedd3c60" instantiates: See on this page: ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 101 % (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "ab7997fa-7b46-1175-3f01-6f6997f7878a" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 ()
Generated Narrative: Observation Resource Observation "4052f28b-64a2-392d-35e4-ec8e912434d2" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 ()
Generated Narrative: Observation Resource Observation "34ebc51d-8105-0589-3c8d-e7aa6bd0a06c" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 ()
Generated Narrative: Observation Resource Observation "2940bf11-05bf-6ce2-3c64-457d0d1f9913" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 ()
Generated Narrative: Observation Resource Observation "332b1e76-6f70-2b4e-5d0c-f22a0e042d3e" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 ()
Generated Narrative: Observation Resource Observation "f0a13a3b-2e8b-594f-6874-6050511e4c57" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 ()
Generated Narrative: Observation Resource Observation "7fe7ccd7-6449-0186-2282-3eeb4cf6a795" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 3 ()
Generated Narrative: Observation Resource Observation "be016630-8754-7414-9014-21e020ad66c6" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 3 ()
Generated Narrative: Observation Resource Observation "92568f68-78f3-908c-6935-ff5f3d574dd6" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 3 ()
Generated Narrative: Observation Resource Observation "a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Individual unspecified degradation products ()
Generated Narrative: Observation Resource Observation "d8533dcb-03f8-5997-6ccf-4f9b6f7a5745" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Individual unspecified degradation products ()
Generated Narrative: Observation Resource Observation "7cec19a2-34a7-6b80-3d60-083b2cc64fcb" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Individual unspecified degradation products ()
Generated Narrative: Observation Resource Observation "27aa47fd-7964-4f96-6495-b2bec7f160e7" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.6 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total degradation products ()
Generated Narrative: Observation Resource Observation "6a78bcde-4781-226c-946e-a4b6915c1899" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.7 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total degradation products ()
Generated Narrative: Observation Resource Observation "f9f11088-7527-947c-3d3f-e71b32e13c78" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.6 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total degradation products ()
Generated Narrative: Observation Resource Observation "66c2f585-678e-78b8-2235-1a3b37bd6e46" instantiates: See on this page: ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467 status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.5 % w/w (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "f8232d25-023d-679f-9c58-a6dc234b7a28" instantiates: See on this page: ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467 status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.5 % w/w (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "368b82be-75dd-1d97-3dbc-a7eed9869daa" instantiates: See on this page: ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467 status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.5 % w/w (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "44aa47fd-8964-4f96-6495-b2bec7f160e7" instantiates: See on this page: ObservationDefinition/64505a3c-5034-448a-9c19-938ce1958424 status: final code: TAMC (Example Local Codes - Drug#TAMC) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 9.1 CFU/100ml
Generated Narrative: Observation Resource Observation "45aa47fd-8964-4f96-6495-b2bec7f160e7" instantiates: See on this page: ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424 status: final code: Conclusion (Example Local Codes - Drug#CONC) subject: : all batches effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Conclusion of filling tests....
Generated Narrative: Observation Resource Observation "45ab47fd-8964-4f96-6495-b2bec7f160e7" instantiates: See on this page: ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424 status: final code: Conclusion (Example Local Codes - Drug#CONC) subject: : all batches effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Conclusion of lyophilization tests....
Generated Narrative: Observation Resource Observation "37aa47fd-8964-4f96-6495-b2bec7f160e7" instantiates: See on this page: ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424 status: final code: Assay (Example Local Codes - Drug#Lyophilizer Number "Lyophilizer Number") subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 1234
Generated Narrative: Observation Resource Observation "38aa47fd-8964-4f96-6495-b2bec7f160e7" instantiates: See on this page: ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424 status: final code: Assay (Example Local Codes - Drug#Lyophilizer Number "Lyophilizer Number") subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 1235
Generated Narrative: Observation Resource Observation "38aa48fd-8964-4f96-6495-b2bec7f160e7" instantiates: See on this page: ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424 status: final code: Assay (Example Local Codes - Drug#Lyophilizer Number "Lyophilizer Number") subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 1236
Generated Narrative: Observation Resource Observation "37aa47fd-7964-4f96-6495-b2bec7f160e7" instantiates: See on this page: ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 97 % (Details: UCUM code % = '%') Components - Code Value[x] * Number of Locations (Example Local Codes - Drug#LOC) 3
Generated Narrative: Observation Resource Observation "47aa47fd-7964-4f96-6495-b2bec7f160e7" instantiates: See on this page: ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 98 % (Details: UCUM code % = '%') Components - Code Value[x] * Number of Locations (Example Local Codes - Drug#LOC) 4
Generated Narrative: Observation Resource Observation "47aa47fd-7964-4f96-6495-b2bec7f160e8" instantiates: See on this page: ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 96 % (Details: UCUM code % = '%') Components - Code Value[x] * Number of Locations (Example Local Codes - Drug#LOC) 2
Generated Narrative: Observation Resource Observation "47aa47fd-8964-4f96-6495-b2bec7f160e7" instantiates: See on this page: ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467 status: final code: Lyophilization Water Homogeneity (Example Local Codes - Drug#Lyophilization Water Homogeneity) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: Do statistically significant effects (Example Local Codes - Drug#SSE "Statistically significant effects") value: Yes component code: Lower one-sided 95% confidence limit of Max Difference (Example Local Codes - Drug#LCL) value: 0.8 % component code: Upper one-sided 95% confidence limit of Max Difference (Example Local Codes - Drug#UCL) value: 0.9 % component code: Was Homogeneity demonstrated? (Example Local Codes - Drug#Homogeneity "Homogeneity demonstrated") value: Yes
Generated Narrative: Observation Resource Observation "47aa47fd-8964-5f96-6495-b2bec7f160e7" instantiates: See on this page: ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467 status: final code: Lyophilization Assay Homogeneity (Example Local Codes - Drug#Lyophilization Assay Homogeneity) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 component code: Do statistically significant effects (Example Local Codes - Drug#SSE "Statistically significant effects") value: No component code: Lower one-sided 95% confidence limit of Max Difference (Example Local Codes - Drug#LCL) value: Not calculated component code: Upper one-sided 95% confidence limit of Max Difference (Example Local Codes - Drug#UCL) value: Not calculated component code: Was Homogeneity demonstrated? (Example Local Codes - Drug#Homogeneity "Homogeneity demonstrated") value: Yes
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/6eb94d34-48b4-5bb0-4c05-e183d2ea3e95
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "6eb94d34-48b4-5bb0-4c05-e183d2ea3e95" manufacturer: See on this page: Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2 Names - Name * Stelbatolol
Generated Narrative: Organization Resource Organization "23dbbd32-2962-9fc3-40b1-67e864f21cd2" 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: SubstanceDefinition Resource SubstanceDefinition "57a9af63-315d-1585-a261-0e337b289390" Profile: SubstanceDefinition - Component Substance Drug PQ manufacturer: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c Names - Name * Stelbatolol
Generated Narrative: Organization Resource Organization "49d2f0c0-4b28-9271-8aaf-2996a8b9739c" Profile: Organization - Drug PQ 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: PlanDefinition Resource PlanDefinition "plandefinition-drug-pq-ex2-manufacturing-plan" Profile: PlanDefinition - Drug PQ Tag: http://terminology.hl7.org/CodeSystem/v3-ObservationValue 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)
Narrative description of manufacturing process (5)
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
Generated Narrative: Substance Resource Substance "fc078762-81c5-5656-9744-13c7ad1e595b" Profile: Substance - Drug PQ Medication Manufacturing Batch url manufacturingDate value: 2019-09-07 url batchQuantity value: 5 kg url batchUtilization value: Development (NCI Thesaurus#C133991) url assignedManufacturer value: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c 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: true Codes - Reference * See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390
Generated Narrative: Substance Resource Substance "cb31d747-2338-88d5-342c-8e9c097e4dad" Medication Manufacturing Batch url manufacturingDate value: 2019-09-07 url batchQuantity value: 5 kg url batchUtilization value: Development (NCI Thesaurus#C133991) url assignedManufacturer value: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Retest Date PQ: 2022-09-08 Extension - Actual Yield PQ: 4.8 kg identifier: CAT2 instance: true Codes - Reference * See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390
Generated Narrative: Substance Resource Substance "1551f97b-6f6d-825e-1fb3-44b0b090808c" Medication Manufacturing Batch url manufacturingDate value: 2019-09-07 url batchQuantity value: 5 kg url batchUtilization value: Development (NCI Thesaurus#C133991) url assignedManufacturer value: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Retest Date PQ: 2022-09-08 Extension - Actual Yield PQ: 4.8 kg identifier: CAT3 instance: true Codes - Reference * See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390