Example: Bundle - Process Validation, product - Pharmaceutical Quality (Industry) v1.0.0

Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Example Bundle: Example: Bundle - Process Validation, product

Bundle bundle-product-process-validation-pq-ex1 of type collection

Entry 1 - fullUrl = urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f

Resource PlanDefinition:

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
action
title: Filling Steps
code: Filling Step (Manufacturing Step Codes#filling)
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

Entry 2 - fullUrl = urn:uuid:fc17b5d5-9fe1-91c2-2d06-47cb5b295e72

Resource ObservationDefinition:

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

Entry 3 - fullUrl = urn:uuid:fc17b5d5-9fe1-91c2-2d06-47cb5b295e73

Resource ObservationDefinition:

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

Entry 4 - fullUrl = urn:uuid:fd17b5d5-9fe1-91c2-2d06-47cb5b295e72

Resource ObservationDefinition:

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

Entry 5 - fullUrl = urn:uuid:fd17b5d5-9fe1-91c2-2d06-47cb5b295e73

Resource ObservationDefinition:

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

Entry 6 - fullUrl = urn:uuid:fc07b5d5-9fe1-92c2-2d06-47cb5b295e72

Resource ObservationDefinition:

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
*

Entry 7 - fullUrl = urn:uuid:fc07b5d5-9fe1-92c3-2d16-47cb5b295e72

Resource ObservationDefinition:

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
*

Entry 8 - fullUrl = urn:uuid:fc07b5d5-9fe1-92c3-2d06-47cb5b295e72

Resource ObservationDefinition:

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
*

Entry 9 - fullUrl = urn:uuid:3b0e878e-4bc9-8864-862f-e28b21233e8d

Resource ObservationDefinition:

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
*

Entry 10 - fullUrl = urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e

Resource ObservationDefinition:

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
*

Entry 11 - fullUrl = urn:uuid:8bdea820-4197-7c7d-0990-7be06bf78aaf

Resource ObservationDefinition:

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)

Entry 12 - fullUrl = urn:uuid:31e29d22-5fcb-546e-24fd-52a4a4004467

Resource ObservationDefinition:

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

Entry 13 - fullUrl = urn:uuid:32e29d22-5fcb-546e-24fd-52a4a4004467

Resource ObservationDefinition:

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

Entry 14 - fullUrl = urn:uuid:32e29d22-6fcb-546e-24fd-52a4a4004467

Resource ObservationDefinition:

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")

Entry 15 - fullUrl = urn:uuid:32e29d32-6fcb-546e-24fd-52a4a4004467

Resource ObservationDefinition:

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")

Entry 16 - fullUrl = urn:uuid:ef17cff1-6586-a5a4-9168-2602140548d7

Resource ObservationDefinition:

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-? %

Entry 17 - fullUrl = urn:uuid:ef17cff1-6586-a5a4-9168-2602140548d8

Resource ObservationDefinition:

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

Entry 18 - fullUrl = urn:uuid:fc17b5d6-9fe1-91c2-2d06-47cb5b295e72

Resource ObservationDefinition:

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

Entry 19 - fullUrl = urn:uuid:22515a3c-5034-448a-9c19-938ce1958424

Resource ObservationDefinition:

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)

Entry 20 - fullUrl = urn:uuid:64505a3c-5034-448a-9c19-938ce1958424

Resource ObservationDefinition:

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

Entry 21 - fullUrl = urn:uuid:64515a3c-5034-448a-9c19-938ce1958424

Resource ObservationDefinition:

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

Entry 22 - fullUrl = urn:uuid:64515a3c-5134-448a-9c19-938ce1958424

Resource ObservationDefinition:

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
*

Entry 23 - fullUrl = urn:uuid:64525a3c-5134-448a-9c19-938ce1958424

Resource ObservationDefinition:

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
*

Entry 24 - fullUrl = urn:uuid:64515a3c-5134-448a-9c29-938ce1958424

Resource ObservationDefinition:

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 %

Entry 25 - fullUrl = urn:uuid:64515a3c-5234-448a-9c29-938ce1958424

Resource ObservationDefinition:

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

Entry 26 - fullUrl = urn:uuid:64515a3c-5334-448a-9c29-938ce1958424

Resource ObservationDefinition:

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

Entry 27 - fullUrl = urn:uuid:64535a3c-5334-448a-9c29-938ce1958424

Resource ObservationDefinition:

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

Entry 28 - fullUrl = urn:uuid:22525a3c-5034-448a-9c19-938ce1958424

Resource ObservationDefinition:

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)

Entry 29 - fullUrl = urn:uuid:64535a3c-5334-448a-9c29-938ce2958424

Resource ObservationDefinition:

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)

Entry 30 - fullUrl = urn:uuid:22e7e672-40a6-4036-3c1f-b8ba6a7d045e

Resource ObservationDefinition:

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)

Entry 31 - fullUrl = urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

Resource Medication:

Generated Narrative: Medication
Resource Medication "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
Profile: Medication - Batch Information Drug PQ
code: ()
Batches
- Extension LotNumber
* , , , , , , , , , 33445

Entry 32 - fullUrl = urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc

Resource Medication:

Generated Narrative: Medication
Resource Medication "a9dfda53-734b-045f-7ae4-94a6281d53bc"
code: ()
Batches
- Extension LotNumber
* , , , , , , , , , 33446

Entry 33 - fullUrl = urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06

Resource Medication:

Generated Narrative: Medication
Resource Medication "c6f5fadd-62e6-3a01-93d9-b3b182f67d06"
code: ()
Batches
- Extension LotNumber
* , , , , , , , , , 33447

Entry 34 - fullUrl = urn:uuid:0102bca4-46c1-a6bf-1025-cd403fee710a

Resource Organization:

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

Entry 35 - fullUrl = urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b07

Resource Organization:

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

Entry 36 - fullUrl = urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08

Resource Organization:

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

Entry 37 - fullUrl = urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd

Resource DiagnosticReport:

Process Validation Report
When For 2020-12
Report Details
Code Value When For
pH (adjustment of pre-clarification bulk solution) 6.91 pH 2023-01-01 12:00:00+0000
pH (adjustment of pre-clarification bulk solution) 6.92 pH 2023-01-01 12:00:00+0000
pH (adjustment of pre-clarification bulk solution) 6.93 pH 2023-01-01 12:00:00+0000
pH (adjustment of pre-clarification bulk solution) 7.01 pH 2023-01-01 12:00:00+0000
pH (adjustment of pre-clarification bulk solution) 7.02 pH 2023-01-01 12:00:00+0000
pH (adjustment of pre-clarification bulk solution) 6.93 pH 2023-01-01 12:00:00+0000
Assay (pre-clarification filtration) (mg/mL) 21.1 mg/mL 2023-01-01 12:00:00+0000
Assay (pre-clarification filtration) (mg/mL) 21.2 mg/mL 2023-01-01 12:00:00+0000
Assay (pre-clarification filtration) (mg/mL) 21.3 mg/mL 2023-01-01 12:00:00+0000
Assay (Post dilution bulk solution) (mg/mL) 20.1 mg/mL 2023-01-01 12:00:00+0000
Assay (Post dilution bulk solution) (mg/mL) 20.2 mg/mL 2023-01-01 12:00:00+0000
Assay (Post dilution bulk solution) (mg/mL) 20.3 mg/mL 2023-01-01 12:00:00+0000
Identification Complies 2023-01-01 12:00:00+0000
Identification Does not comply 2023-01-01 12:00:00+0000
Identification Complies 2023-01-01 12:00:00+0000
Assay 103 % 2023-01-01 12:00:00+0000
Assay 102 % 2023-01-01 12:00:00+0000
Assay 101 % 2023-01-01 12:00:00+0000
Degradation Products 0.1 % w/w 2023-01-01 12:00:00+0000
Degradation Products 0.2 % w/w 2023-01-01 12:00:00+0000
Degradation Products 0.2 % w/w 2023-01-01 12:00:00+0000
Degradation Products 0.2 % w/w 2023-01-01 12:00:00+0000
Degradation Products 0.2 % w/w 2023-01-01 12:00:00+0000
Degradation Products 0.2 % w/w 2023-01-01 12:00:00+0000
Degradation Products 0.2 % w/w 2023-01-01 12:00:00+0000
Degradation Products 0.2 % w/w 2023-01-01 12:00:00+0000
Degradation Products 0.2 % w/w 2023-01-01 12:00:00+0000
Degradation Products 0.1 % w/w 2023-01-01 12:00:00+0000
Degradation Products 0.1 % w/w 2023-01-01 12:00:00+0000
Degradation Products 0.1 % w/w 2023-01-01 12:00:00+0000
Degradation Products 0.6 % w/w 2023-01-01 12:00:00+0000
Degradation Products 0.7 % w/w 2023-01-01 12:00:00+0000
Degradation Products 0.6 % w/w 2023-01-01 12:00:00+0000
Water Content 0.5 % w/w 2023-01-01 12:00:00+0000
Water Content 0.5 % w/w 2023-01-01 12:00:00+0000
Water Content 0.5 % w/w 2023-01-01 12:00:00+0000
TAMC 9.1 CFU/100ml 2023-01-01 12:00:00+0000
Conclusion Conclusion of filling tests.... 2023-01-01 12:00:00+0000
Conclusion Conclusion of lyophilization tests.... 2023-01-01 12:00:00+0000
Assay 1234 2023-01-01 12:00:00+0000
Assay 1235 2023-01-01 12:00:00+0000
Assay 1236 2023-01-01 12:00:00+0000
Assay 97 % 2023-01-01 12:00:00+0000
Assay 98 % 2023-01-01 12:00:00+0000
Assay 96 % 2023-01-01 12:00:00+0000
Lyophilization Water Homogeneity 2023-01-01 12:00:00+0000
Lyophilization Assay Homogeneity 2023-01-01 12:00:00+0000
The samples have been assessed and the conclusion is...

Entry 38 - fullUrl = urn:uuid:f0a04328-905c-4ec5-372e-4d6cfef18629

Resource Observation:

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 ()

Entry 39 - fullUrl = urn:uuid:5e5a5e67-7fc6-0064-1be9-5d9d14d887e5

Resource Observation:

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 ()

Entry 40 - fullUrl = urn:uuid:cfde6776-673c-72e2-68c4-07b77cd85b74

Resource Observation:

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 ()

Entry 41 - fullUrl = urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33

Resource Observation:

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')

Entry 42 - fullUrl = urn:uuid:9c56948a-3a39-6609-1c01-4d197ea57a33

Resource Observation:

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')

Entry 43 - fullUrl = urn:uuid:9c56948a-4a39-6609-1c01-4d197ea57a33

Resource Observation:

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')

Entry 44 - fullUrl = urn:uuid:9c56948a-3a49-6609-1c01-4d197ea57a33

Resource Observation:

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')

Entry 45 - fullUrl = urn:uuid:9c56958a-4a39-6609-1c01-4d197ea57a33

Resource Observation:

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')

Entry 46 - fullUrl = urn:uuid:9c56948a-5a39-6609-1c01-4d197ea57a33

Resource Observation:

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')

Entry 47 - fullUrl = urn:uuid:9c56948a-2a39-6609-1c01-4d297ea57a33

Resource Observation:

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')

Entry 48 - fullUrl = urn:uuid:9c56948a-3a39-6619-1c01-4d197ea57a33

Resource Observation:

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')

Entry 49 - fullUrl = urn:uuid:9c56948a-4a39-6619-1c01-4d197ea57a33

Resource Observation:

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')

Entry 50 - fullUrl = urn:uuid:9c56948a-3a49-6619-1c01-4d197ea57a33

Resource Observation:

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')

Entry 51 - fullUrl = urn:uuid:9c56958a-4a39-6619-1c01-4d197ea57a33

Resource Observation:

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')

Entry 52 - fullUrl = urn:uuid:9c56948a-5a39-6709-1c01-4d197ea57a33

Resource Observation:

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')

Entry 53 - fullUrl = urn:uuid:9c56948a-1a39-6609-1c01-4d197ea57a33

Resource Observation:

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 % = '%')

Entry 54 - fullUrl = urn:uuid:1e20aed7-7626-1664-8d96-235f860d9a2c

Resource Observation:

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 % = '%')

Entry 55 - fullUrl = urn:uuid:ec6d7e30-4d70-491b-0669-a613eedd3c60

Resource Observation:

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 % = '%')

Entry 56 - fullUrl = urn:uuid:ab7997fa-7b46-1175-3f01-6f6997f7878a

Resource Observation:

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 ()

Entry 57 - fullUrl = urn:uuid:4052f28b-64a2-392d-35e4-ec8e912434d2

Resource Observation:

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 ()

Entry 58 - fullUrl = urn:uuid:34ebc51d-8105-0589-3c8d-e7aa6bd0a06c

Resource Observation:

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 ()

Entry 59 - fullUrl = urn:uuid:2940bf11-05bf-6ce2-3c64-457d0d1f9913

Resource Observation:

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 ()

Entry 60 - fullUrl = urn:uuid:332b1e76-6f70-2b4e-5d0c-f22a0e042d3e

Resource Observation:

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 ()

Entry 61 - fullUrl = urn:uuid:f0a13a3b-2e8b-594f-6874-6050511e4c57

Resource Observation:

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 ()

Entry 62 - fullUrl = urn:uuid:7fe7ccd7-6449-0186-2282-3eeb4cf6a795

Resource Observation:

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 ()

Entry 63 - fullUrl = urn:uuid:be016630-8754-7414-9014-21e020ad66c6

Resource Observation:

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 ()

Entry 64 - fullUrl = urn:uuid:92568f68-78f3-908c-6935-ff5f3d574dd6

Resource Observation:

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 ()

Entry 65 - fullUrl = urn:uuid:a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12

Resource Observation:

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 ()

Entry 66 - fullUrl = urn:uuid:d8533dcb-03f8-5997-6ccf-4f9b6f7a5745

Resource Observation:

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 ()

Entry 67 - fullUrl = urn:uuid:7cec19a2-34a7-6b80-3d60-083b2cc64fcb

Resource Observation:

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 ()

Entry 68 - fullUrl = urn:uuid:27aa47fd-7964-4f96-6495-b2bec7f160e7

Resource Observation:

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 ()

Entry 69 - fullUrl = urn:uuid:6a78bcde-4781-226c-946e-a4b6915c1899

Resource Observation:

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 ()

Entry 70 - fullUrl = urn:uuid:f9f11088-7527-947c-3d3f-e71b32e13c78

Resource Observation:

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 ()

Entry 71 - fullUrl = urn:uuid:66c2f585-678e-78b8-2235-1a3b37bd6e46

Resource Observation:

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 % = '%')

Entry 72 - fullUrl = urn:uuid:f8232d25-023d-679f-9c58-a6dc234b7a28

Resource Observation:

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 % = '%')

Entry 73 - fullUrl = urn:uuid:368b82be-75dd-1d97-3dbc-a7eed9869daa

Resource Observation:

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 % = '%')

Entry 74 - fullUrl = urn:uuid:44aa47fd-8964-4f96-6495-b2bec7f160e7

Resource Observation:

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

Entry 75 - fullUrl = urn:uuid:45aa47fd-8964-4f96-6495-b2bec7f160e7

Resource Observation:

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....

Entry 76 - fullUrl = urn:uuid:45ab47fd-8964-4f96-6495-b2bec7f160e7

Resource Observation:

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....

Entry 77 - fullUrl = urn:uuid:37aa47fd-8964-4f96-6495-b2bec7f160e7

Resource Observation:

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

Entry 78 - fullUrl = urn:uuid:38aa47fd-8964-4f96-6495-b2bec7f160e7

Resource Observation:

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

Entry 79 - fullUrl = urn:uuid:38aa48fd-8964-4f96-6495-b2bec7f160e7

Resource Observation:

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

Entry 80 - fullUrl = urn:uuid:37aa47fd-7964-4f96-6495-b2bec7f160e7

Resource Observation:

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

Entry 81 - fullUrl = urn:uuid:47aa47fd-7964-4f96-6495-b2bec7f160e7

Resource Observation:

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

Entry 82 - fullUrl = urn:uuid:47aa47fd-7964-4f96-6495-b2bec7f160e8

Resource Observation:

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

Entry 83 - fullUrl = urn:uuid:47aa47fd-8964-4f96-6495-b2bec7f160e7

Resource Observation:

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

Entry 84 - fullUrl = urn:uuid:47aa47fd-8964-5f96-6495-b2bec7f160e7

Resource Observation:

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

Entry 85 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5

Resource MedicinalProductDefinition:

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)

Entry 86 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6

Resource Ingredient:

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

Entry 87 - fullUrl = urn:uuid:6eb94d34-48b4-5bb0-4c05-e183d2ea3e95

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "6eb94d34-48b4-5bb0-4c05-e183d2ea3e95"
manufacturer: See on this page: Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2
Names
- Name
* Stelbatolol

Entry 88 - fullUrl = urn:uuid:23dbbd32-2962-9fc3-40b1-67e864f21cd2

Resource Organization:

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

Entry 89 - fullUrl = urn:uuid:57a9af63-315d-1585-a261-0e337b289390

Resource SubstanceDefinition:

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

Entry 90 - fullUrl = urn:uuid:49d2f0c0-4b28-9271-8aaf-2996a8b9739c

Resource Organization:

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

Entry 91 - fullUrl = urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a

Resource PlanDefinition:

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)

Entry 92 - fullUrl = urn:uuid:82a39a18-91cf-a29d-76c1-a9e8bad9494d

Resource DeviceDefinition:

Generated Narrative: DeviceDefinition
Resource DeviceDefinition "82a39a18-91cf-a29d-76c1-a9e8bad9494d"
DeviceNames
- Name Type
* Mixing Vessel REGISTEREDNAME
Classifications
- Type
* Mixing Vessel (Device Type - example#mixing-vessel)
Properties
- Type Value[x]
* Capacity (Device Property Codes#Capacity) 1000 litres

Entry 93 - fullUrl = urn:uuid:82a39a18-91cf-b29d-76c1-a9e8bad9494d

Resource DeviceDefinition:

Generated Narrative: DeviceDefinition
Resource DeviceDefinition "82a39a18-91cf-b29d-76c1-a9e8bad9494d"
DeviceNames
- Name Type
* Receiving Tank REGISTEREDNAME
Classifications
- Type
* Receiving Tank (Device Type - example#receiving-tank)
Properties
- Type Value[x]
* Capacity (Device Property Codes#Capacity) 1200 litres

Entry 94 - fullUrl = urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b

Resource Substance:

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

Entry 95 - fullUrl = urn:uuid:cb31d747-2338-88d5-342c-8e9c097e4dad

Resource Substance:

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

Entry 96 - fullUrl = urn:uuid:1551f97b-6f6d-825e-1fb3-44b0b090808c

Resource Substance:

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