Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot 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-ballot 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; CodeSystem - Plan Type#process-validation "Process Validation")

status: ACTIVE

subject: See above (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 (CodeSystem - Manufacturing Step#compounding)

action

action

title: Filling Steps

code: Filling Step (CodeSystem - Manufacturing Step#filling)

action

action

title: Lyophilization Step

code: Lyophilization Step (CodeSystem - Manufacturing Step#lyophilization)

Actions

-CodeDefinition[x]
*Conclusion ()ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424
*Test ()ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424
*Test ()ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e
*Test ()ObservationDefinition/32e29d22-5fcb-546e-24fd-52a4a4004467
*Homogeneity ()ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467
*Homogeneity ()ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467

action

title: Release Step

code: Release Step (CodeSystem - Manufacturing Step#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) (CodeSystem - 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) (CodeSystem - 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) (CodeSystem - 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) (CodeSystem - 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) (CodeSystem - 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) (CodeSystem - 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) (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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 (%) (CodeSystem - Example Local Codes - Drug#WWWH "Water Content Homogeneity")

QualifiedValues

-ExtensionRange
*-1.5-1.5 % w/w

component

code: Do statistically significant effects (CodeSystem - Example Local Codes - Drug#SSE "Statistically significant effects")

component

code: Lower one-sided 95% confidence limit of Max Difference (CodeSystem - Example Local Codes - Drug#LCL)

component

code: Upper one-sided 95% confidence limit of Max Difference (CodeSystem - Example Local Codes - Drug#UCL)

component

code: Was Homogeneity demonstrated? (CodeSystem - 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) (CodeSystem - Example Local Codes - Drug#ASSH "Assay Content Homogeneity")

QualifiedValues

-ExtensionRange
*-2.3-2.3 %

component

code: Do statistically significant effects (CodeSystem - Example Local Codes - Drug#SSE "Statistically significant effects")

component

code: Lower one-sided 95% confidence limit of Max Difference (CodeSystem - Example Local Codes - Drug#LCL)

component

code: Upper one-sided 95% confidence limit of Max Difference (CodeSystem - Example Local Codes - Drug#UCL)

component

code: Was Homogeneity demonstrated? (CodeSystem - 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 (CodeSystem - 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) (CodeSystem - 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) (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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) (CodeSystem - 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 (CodeSystem - Example Local Codes - Drug#Actual Avg. Weight from Target)

QualifiedValues

-ExtensionRange
*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) (CodeSystem - 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) (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - Example Local Codes - Drug#ASSAY)

method: Assay by UHPLC ()

QualifiedValues

-ExtensionRange
*95-105 %

Components

-Code
*Number of Locations (CodeSystem - 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

-ExtensionLotNumber
*, , , , , , , , , 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

-ExtensionLotNumber
*, , , , , , , , , 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

-ExtensionLotNumber
*, , , , , , , , , 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

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"

name: MySite


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

Resource Organization:

Generated Narrative: Organization

Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b08"

name: Testing Lab


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

Resource DiagnosticReport:

Process Validation Report

When For2020-12

Report Details

CodeValueWhen For
pH (adjustment of pre-clarification bulk solution)6.91 pH2023-01-01 12:00:00+0000
pH (adjustment of pre-clarification bulk solution)6.92 pH2023-01-01 12:00:00+0000
pH (adjustment of pre-clarification bulk solution)6.93 pH2023-01-01 12:00:00+0000
pH (adjustment of pre-clarification bulk solution)7.01 pH2023-01-01 12:00:00+0000
pH (adjustment of pre-clarification bulk solution)7.02 pH2023-01-01 12:00:00+0000
pH (adjustment of pre-clarification bulk solution)6.93 pH2023-01-01 12:00:00+0000
Assay (pre-clarification filtration) (mg/mL)21.1 mg/mL2023-01-01 12:00:00+0000
Assay (pre-clarification filtration) (mg/mL)21.2 mg/mL2023-01-01 12:00:00+0000
Assay (pre-clarification filtration) (mg/mL)21.3 mg/mL2023-01-01 12:00:00+0000
Assay (Post dilution bulk solution) (mg/mL)20.1 mg/mL2023-01-01 12:00:00+0000
Assay (Post dilution bulk solution) (mg/mL)20.2 mg/mL2023-01-01 12:00:00+0000
Assay (Post dilution bulk solution) (mg/mL)20.3 mg/mL2023-01-01 12:00:00+0000
IdentificationComplies2023-01-01 12:00:00+0000
IdentificationDoes not comply2023-01-01 12:00:00+0000
IdentificationComplies2023-01-01 12:00:00+0000
Assay103 %2023-01-01 12:00:00+0000
Assay102 %2023-01-01 12:00:00+0000
Assay101 %2023-01-01 12:00:00+0000
Degradation Products0.1 % w/w2023-01-01 12:00:00+0000
Degradation Products0.2 % w/w2023-01-01 12:00:00+0000
Degradation Products0.2 % w/w2023-01-01 12:00:00+0000
Degradation Products0.2 % w/w2023-01-01 12:00:00+0000
Degradation Products0.2 % w/w2023-01-01 12:00:00+0000
Degradation Products0.2 % w/w2023-01-01 12:00:00+0000
Degradation Products0.2 % w/w2023-01-01 12:00:00+0000
Degradation Products0.2 % w/w2023-01-01 12:00:00+0000
Degradation Products0.2 % w/w2023-01-01 12:00:00+0000
Degradation Products0.1 % w/w2023-01-01 12:00:00+0000
Degradation Products0.1 % w/w2023-01-01 12:00:00+0000
Degradation Products0.1 % w/w2023-01-01 12:00:00+0000
Degradation Products0.6 % w/w2023-01-01 12:00:00+0000
Degradation Products0.7 % w/w2023-01-01 12:00:00+0000
Degradation Products0.6 % w/w2023-01-01 12:00:00+0000
Water Content0.5 % w/w2023-01-01 12:00:00+0000
Water Content0.5 % w/w2023-01-01 12:00:00+0000
Water Content0.5 % w/w2023-01-01 12:00:00+0000
TAMC9.1 CFU/100ml2023-01-01 12:00:00+0000
ConclusionConclusion of filling tests....2023-01-01 12:00:00+0000
ConclusionConclusion of lyophilization tests....2023-01-01 12:00:00+0000
Assay12342023-01-01 12:00:00+0000
Assay12352023-01-01 12:00:00+0000
Assay12362023-01-01 12:00:00+0000
Assay97 %2023-01-01 12:00:00+0000
Assay98 %2023-01-01 12:00:00+0000
Assay96 %2023-01-01 12:00:00+0000
Lyophilization Water Homogeneity2023-01-01 12:00:00+0000
Lyophilization Assay Homogeneity2023-01-01 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 above (ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d)

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d)

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d)

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72)

status: FINAL

code: pH (adjustment of pre-clarification bulk solution) (CodeSystem - Example Local Codes - Drug#pH (adjustment of pre-clarification bulk solution))

subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72)

status: FINAL

code: pH (adjustment of pre-clarification bulk solution) (CodeSystem - Example Local Codes - Drug#pH (adjustment of pre-clarification bulk solution))

subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72)

status: FINAL

code: pH (adjustment of pre-clarification bulk solution) (CodeSystem - Example Local Codes - Drug#pH (adjustment of pre-clarification bulk solution))

subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73)

status: FINAL

code: pH (adjustment of pre-clarification bulk solution) (CodeSystem - Example Local Codes - Drug#pH (adjustment of pre-clarification bulk solution))

subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73)

status: FINAL

code: pH (adjustment of pre-clarification bulk solution) (CodeSystem - Example Local Codes - Drug#pH (adjustment of pre-clarification bulk solution))

subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73)

status: FINAL

code: pH (adjustment of pre-clarification bulk solution) (CodeSystem - Example Local Codes - Drug#pH (adjustment of pre-clarification bulk solution))

subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72)

status: FINAL

code: Assay (pre-clarification filtration) (mg/mL) (CodeSystem - Example Local Codes - Drug#Assay (pre-clarification filtration) (mg/mL))

subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72)

status: FINAL

code: Assay (pre-clarification filtration) (mg/mL) (CodeSystem - Example Local Codes - Drug#Assay (pre-clarification filtration) (mg/mL))

subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72)

status: FINAL

code: Assay (pre-clarification filtration) (mg/mL) (CodeSystem - Example Local Codes - Drug#Assay (pre-clarification filtration) (mg/mL))

subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73)

status: FINAL

code: Assay (Post dilution bulk solution) (mg/mL) (CodeSystem - Example Local Codes - Drug#Assay (Post dilution bulk solution) (mg/mL))

subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73)

status: FINAL

code: Assay (Post dilution bulk solution) (mg/mL) (CodeSystem - Example Local Codes - Drug#Assay (Post dilution bulk solution) (mg/mL))

subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73)

status: FINAL

code: Assay (Post dilution bulk solution) (mg/mL) (CodeSystem - Example Local Codes - Drug#Assay (Post dilution bulk solution) (mg/mL))

subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.1 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - 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 above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.2 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - 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 above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.2 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - 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 above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.2 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - 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 above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.2 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - 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 above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.2 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - 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 above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.2 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - 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 above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.2 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - 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 above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.2 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - 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 above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.1 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - 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 above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.1 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - 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 above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.1 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - 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 above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.6 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - 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 above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.7 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - 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 above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.6 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - 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 above (ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467)

status: FINAL

code: Water Content (CodeSystem - Example Local Codes - Drug#WaterContent)

subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467)

status: FINAL

code: Water Content (CodeSystem - Example Local Codes - Drug#WaterContent)

subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467)

status: FINAL

code: Water Content (CodeSystem - Example Local Codes - Drug#WaterContent)

subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/64505a3c-5034-448a-9c19-938ce1958424)

status: FINAL

code: TAMC (CodeSystem - Example Local Codes - Drug#TAMC)

subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424)

status: FINAL

code: Conclusion (CodeSystem - Example Local Codes - Drug#CONC)

subject: : all batches

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424)

status: FINAL

code: Conclusion (CodeSystem - Example Local Codes - Drug#CONC)

subject: : all batches

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#Lyophilizer Number "Lyophilizer Number")

subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#Lyophilizer Number "Lyophilizer Number")

subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#Lyophilizer Number "Lyophilizer Number")

subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)

effective: 2023-01-01 12:00:00+0000

performer: See above (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 above (ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 97 % (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Number of Locations (CodeSystem - 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 above (ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 98 % (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Number of Locations (CodeSystem - 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 above (ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 96 % (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Number of Locations (CodeSystem - 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 above (ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467)

status: FINAL

code: Lyophilization Water Homogeneity (CodeSystem - Example Local Codes - Drug#Lyophilization Water Homogeneity)

subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

component

code: Do statistically significant effects (CodeSystem - Example Local Codes - Drug#SSE "Statistically significant effects")

value: Yes

component

code: Lower one-sided 95% confidence limit of Max Difference (CodeSystem - Example Local Codes - Drug#LCL)

value: 0.8 %

component

code: Upper one-sided 95% confidence limit of Max Difference (CodeSystem - Example Local Codes - Drug#UCL)

value: 0.9 %

component

code: Was Homogeneity demonstrated? (CodeSystem - 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 above (ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467)

status: FINAL

code: Lyophilization Assay Homogeneity (CodeSystem - Example Local Codes - Drug#Lyophilization Assay Homogeneity)

subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

component

code: Do statistically significant effects (CodeSystem - Example Local Codes - Drug#SSE "Statistically significant effects")

value: No

component

code: Lower one-sided 95% confidence limit of Max Difference (CodeSystem - Example Local Codes - Drug#LCL)

value: Not calculated

component

code: Upper one-sided 95% confidence limit of Max Difference (CodeSystem - Example Local Codes - Drug#UCL)

value: Not calculated

component

code: Was Homogeneity demonstrated? (CodeSystem - 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 (CodeSystem - Product Name Type#Proprietary)

Parts

-PartType
*20mgStrength 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 above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)

role: Active (Ingredient Role#100000072072)

substance

Codes

-Reference
*See above (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 above (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

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 above (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

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; CodeSystem - Plan Type#manufacturing-process "Manufacturing Process")

status: ACTIVE

subject: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)

description: Narrative description of manufacturing process (5)

goal

id

goal-control-pH

category: Physical Property (CodeSystem - Test Category#C123456)

description: Controls - pH ()

priority: Critical (CodeSystem - Goal Priority#critical)

Targets

-MeasureDetail[x]
*pH must be in range 6.9 to 7.1 (CodeSystem - Example Local Codes - Drug#pH "pH")6.9-7.1 pH

goal

id

goal-control-water-content

category: Physical Property (CodeSystem - Test Category#C123456)

description: Controls - Water Content ()

priority: Critical (CodeSystem - Goal Priority#critical)

Targets

-MeasureDetail[x]
*Under 2% (CodeSystem - Example Local Codes - Drug#WaterContent "Water content")?-2

goal

id

goal-control-particle-size

category: Physical Property (CodeSystem - Test Category#C123456)

description: Controls - Particle Size ()

priority: Critical (CodeSystem - Goal Priority#critical)

Targets

-MeasureDetail[x]
*Under 200 microns (CodeSystem - Example Local Codes - Drug#particle-size "Particle Size")?-200

actor

Options

-TypeReferenceRole
*See above (DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d)Mixing Vessel (CodeSystem - Equipment Class#mixing-vessel)

actor

Options

-TypeReferenceRole
*See above (DeviceDefinition/82a39a18-91cf-b29d-76c1-a9e8bad9494d)Receiving Vessel (CodeSystem - Equipment Class#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

-NameType
*Mixing VesselREGISTEREDNAME

Classifications

-Type
*Mixing Vessel (CodeSystem - Device Type#mixing-vessel)

Properties

-TypeValue[x]
*Capacity (CodeSystem - Device Property#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

-NameType
*Receiving TankREGISTEREDNAME

Classifications

-Type
*Receiving Tank (CodeSystem - Device Type#receiving-tank)

Properties

-TypeValue[x]
*Capacity (CodeSystem - Device Property#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 above (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 above (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 above (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 above (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 above (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 above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)