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
Bundle bundle-product-process-validation-pq-ex2-sub 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: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390
description: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...
action
Extension - Process Step Scale PQ: Production Scale (Details: http://terminology.hl7.org/CodeSystem/manufacturing-step-scale code PROD = 'Production Scale', stated as 'Production Scale')
Extension - Process Parameters PQ
url
parameter
value: Mix speed (Process Parameter Codes#SPEED)
url
value
value: 1500 rpm
prefix: 1
title: Step 1 Yield
description: Description of this step
code: Particle Size Reduction (Manufacturing Step Codes#particleSizeReduction)
participant
typeReference: : Starting material
role: Starting Material (Manufacturing Participant Role Codes#StartingMaterial)
participant
typeReference: : Intermediate material
role: Intermediate Material (Manufacturing Participant Role Codes#IntermediateMaterial)
participant
typeReference: : Resulting material
role: Resulting Material (Manufacturing Participant Role Codes#ResultingMaterial)
Actions
Code Definition[x] Test () http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72 action
title: Step 1 In-Process Control Data
code: Step 1 In-Process Control Data (Manufacturing Step Codes#Step1In-ProcessControlData)
Actions
action
title: Step 1 DS Release Testing Results
code: Step 1 DS Release Testing Results (Manufacturing Step Codes#Step1DSReleaseTestingResults)
Actions
action
Extension - Process Step Scale PQ: Production Scale (Details: http://terminology.hl7.org/CodeSystem/manufacturing-step-scale code PROD = 'Production Scale', stated as 'Production Scale')
prefix: 2
title: Step 2 Yield
description: Description of this step
code: Drying (Manufacturing Step Codes#drying)
participant
typeReference: : Starting material
role: Starting Material (Manufacturing Participant Role Codes#StartingMaterial)
participant
typeReference: : Intermediate material
role: Intermediate Material (Manufacturing Participant Role Codes#IntermediateMaterial)
participant
typeReference: : Resulting material
role: Resulting Material (Manufacturing Participant Role Codes#ResultingMaterial)
Actions
Code Definition[x] Test () http://example-server.com/fhir/ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72
Entry 2 - fullUrl = urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd
Resource DiagnosticReport:
Process Validation Report
When For 2020-12 Report Details
Code Value When For Yield (%) 75 % 2023-01-01 12:00:00+0000 Yield (%) 77 % 2023-01-01 12:00:00+0000 Yield (%) 76 % 2023-01-01 12:00:00+0000 ResidualWaterContent (w/w%) 6.9 % 2023-01-01 12:00:00+0000 ResidualWaterContent (w/w%) 7.0 % 2023-01-01 12:00:00+0000 ResidualWaterContent (w/w%) 6.8 % 2023-01-01 12:00:00+0000 Appearance Off-white solid 2023-01-01 12:00:00+0000 Appearance Off-white solid 2023-01-01 12:00:00+0000 Appearance Off-white solid 2023-01-01 12:00:00+0000 ID by HPLC Conforms 2023-01-01 12:00:00+0000 ID by HPLC Conforms 2023-01-01 12:00:00+0000 ID by HPLC Does not conform 2023-01-01 12:00:00+0000 Yield (%) 85 % 2023-01-01 12:00:00+0000 Yield (%) 87 % 2023-01-01 12:00:00+0000 Yield (%) 86 % 2023-01-01 12:00:00+0000 The samples have been assessed and the conclusion is...
Entry 3 - fullUrl = urn:uuid:fc07b5d5-9fe1-92c2-2d06-57cb5b295e72
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "fc07b5d5-9fe1-92c2-2d06-57cb5b295e72"
url:
http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72
title: Appearance
status: ACTIVE
code: Appearance (Example Local Codes - Drug#Appearance)
method: Visual inspection ()
QualifiedValues
Extension
Entry 4 - fullUrl = urn:uuid:3b1e878e-4bc9-8864-862f-e28b21233e8d
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "3b1e878e-4bc9-8864-862f-e28b21233e8d"
url:
http://example-server.com/fhir/ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d
title: ID by HPLC
status: ACTIVE
code: ID by HPLC (Example Local Codes - Drug#IDT "Identification")
method: ID by UHPLC ()
QualifiedValues
Extension
Entry 5 - 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 by HPLC (as is) (w/w%)
status: ACTIVE
code: Assay by HPLC (as is) (w/w%) (Example Local Codes - Drug#ASSAY "Assay")
method: Assay by UHPLC ()
QualifiedValues
Range 95-101 %
Entry 6 - fullUrl = urn:uuid:fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "fd17b5d6-9fe1-91c2-2d06-47cb5b295e72"
url:
http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
title: Yield (%)
status: ACTIVE
code: Yield (%) (Example Local Codes - Drug#Yield (%))
Entry 7 - fullUrl = urn:uuid:fd17b5d7-9fe1-91c2-2d06-47cb5b295e72
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "fd17b5d7-9fe1-91c2-2d06-47cb5b295e72"
url:
http://example-server.com/fhir/ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72
title: Yield (%)
status: ACTIVE
code: Yield (%) (Example Local Codes - Drug#Yield (%))
Entry 8 - fullUrl = urn:uuid:fc27b5d6-9fe1-91c2-2d16-57cb5b295e72
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "fc27b5d6-9fe1-91c2-2d16-57cb5b295e72"
url:
http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72
title: Residual Water Content (w/w%)
status: ACTIVE
code: Residual Water Content (w/w%) (Example Local Codes - Drug#ResidualWaterContent)
QualifiedValues
Extension Range ?-7.15
Entry 9 - fullUrl = urn:uuid:fc27b5d6-9ff1-91c2-2d16-57cb5b295e72
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "fc27b5d6-9ff1-91c2-2d16-57cb5b295e72"
url:
http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9ff1-91c2-2d16-57cb5b295e72
title: Reaction conversion: residual starting material 1 by HPLC (Step Aa) (LC area %)
status: ACTIVE
code: Reaction conversion: Residual Starting Material 1 by HPLC (Example Local Codes - Drug#Reaction conversion: Residual Starting Material 1 by HPLC)
QualifiedValues
Extension Range ?-23
Entry 10 - fullUrl = urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56948c-2a39-6609-2c01-4d197ea57a33"
instantiates: See on this page: ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72
status: FINAL
code: Appearance (Example Local Codes - Drug#Appearance)
subject: See on this page: Substance/fc178763-81c5-5656-9744-13c7ad1e595b
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Off-white solid
Entry 11 - fullUrl = urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56948c-2a49-6609-2c01-4d197ea57a33"
instantiates: See on this page: ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72
status: FINAL
code: Appearance (Example Local Codes - Drug#Appearance)
subject: See on this page: Substance/fc178764-81d5-5656-9744-13c7ad1e595b
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Off-white solid
Entry 12 - fullUrl = urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56948c-2a39-6609-2c01-4d197eb57a33"
instantiates: See on this page: ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72
status: FINAL
code: Appearance (Example Local Codes - Drug#Appearance)
subject: See on this page: Substance/fc178764-81d6-5656-9744-13c7ad1e595b
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Off-white solid
Entry 13 - fullUrl = urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56958c-2a39-6609-2c01-4d197ea57a33"
instantiates: See on this page: ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d
status: FINAL
code: ID by HPLC (Example Local Codes - Drug#IDT "Identification")
subject: See on this page: Substance/fc178763-81c5-5656-9744-13c7ad1e595b
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Conforms
Entry 14 - fullUrl = urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56968c-2a49-6609-2c01-4d197ea57a33"
instantiates: See on this page: ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d
status: FINAL
code: ID by HPLC (Example Local Codes - Drug#IDT "Identification")
subject: See on this page: Substance/fc178764-81d5-5656-9744-13c7ad1e595b
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Conforms
Entry 15 - fullUrl = urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56978c-2a39-6609-2c01-4d197eb57a33"
instantiates: See on this page: ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d
status: FINAL
code: ID by HPLC (Example Local Codes - Drug#IDT "Identification")
subject: See on this page: Substance/fc178764-81d6-5656-9744-13c7ad1e595b
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Does not conform
Entry 16 - fullUrl = urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56948c-2a39-6609-1c01-4d197ea57a33"
instantiates: See on this page: ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
status: FINAL
code: Yield (%) (Example Local Codes - Drug#Yield (%))
subject: See on this page: Substance/fc178763-81c5-5656-9744-13c7ad1e595b
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 75 %
Entry 17 - fullUrl = urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56948a-2b39-6609-1c01-4d197ea57a33"
instantiates: See on this page: ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
status: FINAL
code: Yield (%) (Example Local Codes - Drug#Yield (%))
subject: See on this page: Substance/fc178764-81d5-5656-9744-13c7ad1e595b
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 77 %
Entry 18 - 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/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
status: FINAL
code: Yield (%) (Example Local Codes - Drug#Yield (%))
subject: See on this page: Substance/fc178764-81d6-5656-9744-13c7ad1e595b
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 76 %
Entry 19 - fullUrl = urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56948d-2a39-6609-1c01-4d197ea57a33"
instantiates: See on this page: ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72
status: FINAL
code: Yield (%) (Example Local Codes - Drug#Yield (%))
subject: See on this page: Substance/fc178763-81c5-5656-9754-13c7ad1e595b
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 85 %
Entry 20 - fullUrl = urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56948c-2b39-6609-1c01-4d197ea57a33"
instantiates: See on this page: ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72
status: FINAL
code: Yield (%) (Example Local Codes - Drug#Yield (%))
subject: See on this page: Substance/fc178764-81d5-5656-9764-13c7ad1e595b
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 87 %
Entry 21 - fullUrl = urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56948b-2a39-6609-1c01-4d197ea57a33"
instantiates: See on this page: ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72
status: FINAL
code: Yield (%) (Example Local Codes - Drug#Yield (%))
subject: See on this page: Substance/fc178764-81d6-6656-9744-13c7ad1e595b
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 86 %
Entry 22 - fullUrl = urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56958c-2a39-6609-1c01-4d197ea57a33"
instantiates: See on this page: ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72
status: FINAL
code: ResidualWaterContent (w/w%) (Example Local Codes - Drug#ResidualWaterContent "Residual Water Content (w/w%)")
subject: See on this page: Substance/fc178763-81c5-5656-9744-13c7ad1e595b
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 6.9 %
Entry 23 - fullUrl = urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56968a-2b39-6609-1c01-4d197ea57a33"
instantiates: See on this page: ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72
status: FINAL
code: ResidualWaterContent (w/w%) (Example Local Codes - Drug#ResidualWaterContent "Residual Water Content (w/w%)")
subject: See on this page: Substance/fc178764-81d5-5656-9744-13c7ad1e595b
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 7.0 %
Entry 24 - fullUrl = urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33
Resource Observation:
Generated Narrative: Observation
Resource Observation "9c56978a-2a39-6609-1c01-4d197ea57a33"
instantiates: See on this page: ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72
status: FINAL
code: ResidualWaterContent (w/w%) (Example Local Codes - Drug#ResidualWaterContent "Residual Water Content (w/w%)")
subject: See on this page: Substance/fc178764-81d6-5656-9744-13c7ad1e595b
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 6.8 %
Entry 25 - 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
/3003040516active: 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 26 - 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
/3007270600active: true
type: Analytical Testing - Release (Pharmaceutical Organization Type Codes#analytical-testing-release)
name: Testing Lab
Entry 27 - fullUrl = urn:uuid:57a9af63-315d-1585-a261-0e337b289390
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "57a9af63-315d-1585-a261-0e337b289390"
manufacturer: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c
Names
Name Stelbatolol
Entry 28 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821153
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821153"
manufacturer: See on this page: Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2
Names
Name Stelbatosubstance
Entry 29 - fullUrl = urn:uuid:fc178762-81c5-5656-9744-13c7ad1e595b
Resource Substance:
Generated Narrative: Substance
Resource Substance "fc178762-81c5-5656-9744-13c7ad1e595b"
Profile: Substance - Drug PQ
Medication Manufacturing Batch
url
manufacturingDate
value: 2019-09-01
url
batchQuantity
value: 8.1 kg
identifier: Start1Amgen
instance: true
Codes
Reference See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821153
Entry 30 - fullUrl = urn:uuid:fc178762-81d5-5656-9744-13c7ad1e595b
Resource Substance:
Generated Narrative: Substance
Resource Substance "fc178762-81d5-5656-9744-13c7ad1e595b"
Profile: Substance - Drug PQ
Medication Manufacturing Batch
url
manufacturingDate
value: 2019-09-01
url
batchQuantity
value: 8.2 kg
identifier: Start2Amgen
instance: true
Codes
Reference See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821153
Entry 31 - fullUrl = urn:uuid:fc178762-81d5-5656-9744-23c7ad1e595b
Resource Substance:
Generated Narrative: Substance
Resource Substance "fc178762-81d5-5656-9744-23c7ad1e595b"
Profile: Substance - Drug PQ
Medication Manufacturing Batch
url
manufacturingDate
value: 2019-09-01
url
batchQuantity
value: 8.3 kg
identifier: Start3Amgen
instance: true
Codes
Reference See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821153
Entry 32 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821154
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821154"
Names
Name Resultothane
Entry 33 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821155
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821155"
manufacturer: See on this page: Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2
Names
Name Processohol
Entry 34 - fullUrl = urn:uuid:fc178763-81c5-5656-9744-13c7ad1e595b
Resource Substance:
Generated Narrative: Substance
Resource Substance "fc178763-81c5-5656-9744-13c7ad1e595b"
Profile: Substance - Drug PQ
Medication Manufacturing Batch
url
batchQuantity
value: 9.1 kg
Extension - Batch Derived From PQ: See on this page: Substance/fc178762-81c5-5656-9744-13c7ad1e595b
identifier: Intermed1Amgen
instance: true
Codes
Reference See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821155
Entry 35 - fullUrl = urn:uuid:fc178764-81d5-5656-9744-13c7ad1e595b
Resource Substance:
Generated Narrative: Substance
Resource Substance "fc178764-81d5-5656-9744-13c7ad1e595b"
Profile: Substance - Drug PQ
Medication Manufacturing Batch
url
batchQuantity
value: 9.2 kg
Extension - Batch Derived From PQ: See on this page: Substance/fc178762-81d5-5656-9744-13c7ad1e595b
identifier: Intermed2Amgen
instance: true
Codes
Reference See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821155
Entry 36 - fullUrl = urn:uuid:fc178764-81d6-5656-9744-13c7ad1e595b
Resource Substance:
Generated Narrative: Substance
Resource Substance "fc178764-81d6-5656-9744-13c7ad1e595b"
Profile: Substance - Drug PQ
Medication Manufacturing Batch
url
batchQuantity
value: 9.3 kg
Extension - Batch Derived From PQ: See on this page: Substance/fc178762-81d5-5656-9744-23c7ad1e595b
identifier: Intermed3Amgen
instance: true
Codes
Reference See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821155
Entry 37 - fullUrl = urn:uuid:c458791f-8cb8-428e-83f7-8a205f821153
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "c458791f-8cb8-428e-83f7-8a205f821153"
manufacturer: See on this page: Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2
Names
Name Stelbatosubstance2
Entry 38 - fullUrl = urn:uuid:fc178762-81c5-5656-9744-13c7ad2e595b
Resource Substance:
Generated Narrative: Substance
Resource Substance "fc178762-81c5-5656-9744-13c7ad2e595b"
Profile: Substance - Drug PQ
Medication Manufacturing Batch
url
manufacturingDate
value: 2019-09-02
url
batchQuantity
value: 7.1 kg
identifier: Start1Step2Amgen
instance: true
Codes
Reference See on this page: SubstanceDefinition/c458791f-8cb8-428e-83f7-8a205f821153
Entry 39 - fullUrl = urn:uuid:fc178762-81d5-5656-9744-13c7ad1e596b
Resource Substance:
Generated Narrative: Substance
Resource Substance "fc178762-81d5-5656-9744-13c7ad1e596b"
Profile: Substance - Drug PQ
Medication Manufacturing Batch
url
manufacturingDate
value: 2019-09-02
url
batchQuantity
value: 7.2 kg
identifier: Start2Step2Amgen
instance: true
Codes
Reference See on this page: SubstanceDefinition/c458791f-8cb8-428e-83f7-8a205f821153
Entry 40 - fullUrl = urn:uuid:fc178762-81d5-5656-9744-23c7ad1e597b
Resource Substance:
Generated Narrative: Substance
Resource Substance "fc178762-81d5-5656-9744-23c7ad1e597b"
Profile: Substance - Drug PQ
Medication Manufacturing Batch
url
manufacturingDate
value: 2019-09-02
url
batchQuantity
value: 7.3 kg
identifier: Start3Step2Amgen
instance: true
Codes
Reference See on this page: SubstanceDefinition/c458791f-8cb8-428e-83f7-8a205f821153
Entry 41 - fullUrl = urn:uuid:c458791f-7cb8-428e-84f7-8a205f821155
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "c458791f-7cb8-428e-84f7-8a205f821155"
manufacturer: See on this page: Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2
Names
Name ProcessoholStep2
Entry 42 - fullUrl = urn:uuid:fc178763-81c5-5656-9754-13c7ad1e595b
Resource Substance:
Generated Narrative: Substance
Resource Substance "fc178763-81c5-5656-9754-13c7ad1e595b"
Profile: Substance - Drug PQ
Medication Manufacturing Batch
url
batchQuantity
value: 10.1 kg
Extension - Batch Derived From PQ: See on this page: Substance/fc178762-81c5-5656-9744-13c7ad2e595b
identifier: Intermed1Step2Amgen
instance: true
Codes
Reference See on this page: SubstanceDefinition/c458791f-7cb8-428e-84f7-8a205f821155
Entry 43 - fullUrl = urn:uuid:fc178764-81d5-5656-9764-13c7ad1e595b
Resource Substance:
Generated Narrative: Substance
Resource Substance "fc178764-81d5-5656-9764-13c7ad1e595b"
Profile: Substance - Drug PQ
Medication Manufacturing Batch
url
batchQuantity
value: 10.2 kg
Extension - Batch Derived From PQ: See on this page: Substance/fc178762-81d5-5656-9744-13c7ad1e596b
identifier: Intermed2Step2Amgen
instance: true
Codes
Reference See on this page: SubstanceDefinition/c458791f-7cb8-428e-84f7-8a205f821155
Entry 44 - fullUrl = urn:uuid:fc178764-81d6-6656-9744-13c7ad1e595b
Resource Substance:
Generated Narrative: Substance
Resource Substance "fc178764-81d6-6656-9744-13c7ad1e595b"
Profile: Substance - Drug PQ
Medication Manufacturing Batch
url
batchQuantity
value: 10.3 kg
Extension - Batch Derived From PQ: See on this page: Substance/fc178762-81d5-5656-9744-23c7ad1e597b
identifier: Intermed3Step2Amgen
instance: true
Codes
Reference See on this page: SubstanceDefinition/c458791f-7cb8-428e-84f7-8a205f821155
Entry 45 - fullUrl = urn:uuid:c458791f-8cb8-428e-83f7-8a205f821154
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "c458791f-8cb8-428e-83f7-8a205f821154"
Names
Name ResultothaneStep2
Entry 46 - 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
/3003040516active: 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 47 - 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: 5.1 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: SUB1Amgen, SUB1SiteA
instance: true
Codes
Reference See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390
Entry 48 - 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: 5.2 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: SUB2Amgen, SUB2SiteA
instance: true
Codes
Reference See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390
Entry 49 - 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: 5.3 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: SUB3Amgen, SUB3SiteA
instance: true
Codes
Reference See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390