Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot International flag

This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Example Bundle: Example: Bundle - Process Validation, substance

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; CodeSystem - Plan Type#process-validation "Process Validation")

status: ACTIVE

subject: See above (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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq code PROD = 'Production Scale', stated as 'Production Scale')

Extension - Process Parameters PQ

url

parameter

value: Mix speed (CodeSystem - Process Parameter#SPEED)

url

value

value: 1500 rpm

prefix: 1

title: Step 1 Yield

description: Description of this step

code: Particle Size Reduction (CodeSystem - Manufacturing Step#particleSizeReduction)

participant

typeReference: : Starting material

role: Starting Material (CodeSystem - Manufacturing Participant Role#StartingMaterial)

participant

typeReference: : Intermediate material

role: Intermediate Material (CodeSystem - Manufacturing Participant Role#IntermediateMaterial)

participant

typeReference: : Resulting material

role: Resulting Material (CodeSystem - Manufacturing Participant Role#ResultingMaterial)

Actions

-CodeDefinition[x]
*Test ()ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72

action

title: Step 1 In-Process Control Data

code: Step 1 In-Process Control Data (CodeSystem - Manufacturing Step#Step1In-ProcessControlData)

Actions

-CodeDefinition[x]
*Test ()ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72
*Test ()ObservationDefinition/fc27b5d6-9ff1-91c2-2d16-57cb5b295e72

action

title: Step 1 DS Release Testing Results

code: Step 1 DS Release Testing Results (CodeSystem - Manufacturing Step#Step1DSReleaseTestingResults)

Actions

-CodeDefinition[x]
*Test ()ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72
*Test ()ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d
*Test ()ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e

action

Extension - Process Step Scale PQ: Production Scale (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq code PROD = 'Production Scale', stated as 'Production Scale')

prefix: 2

title: Step 2 Yield

description: Description of this step

code: Drying (CodeSystem - Manufacturing Step#drying)

participant

typeReference: : Starting material

role: Starting Material (CodeSystem - Manufacturing Participant Role#StartingMaterial)

participant

typeReference: : Intermediate material

role: Intermediate Material (CodeSystem - Manufacturing Participant Role#IntermediateMaterial)

participant

typeReference: : Resulting material

role: Resulting Material (CodeSystem - Manufacturing Participant Role#ResultingMaterial)

Actions

-CodeDefinition[x]
*Test ()ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72

Entry 2 - fullUrl = urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd

Resource DiagnosticReport:

Process Validation Report

When For2020-12

Report Details

CodeValueWhen 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
AppearanceOff-white solid2023-01-01 12:00:00+0000
AppearanceOff-white solid2023-01-01 12:00:00+0000
AppearanceOff-white solid2023-01-01 12:00:00+0000
ID by HPLCConforms2023-01-01 12:00:00+0000
ID by HPLCConforms2023-01-01 12:00:00+0000
ID by HPLCDoes not conform2023-01-01 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 (CodeSystem - 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 (CodeSystem - 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%) (CodeSystem - 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 (%) (CodeSystem - 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 (%) (CodeSystem - 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%) (CodeSystem - Example Local Codes - Drug#ResidualWaterContent)

QualifiedValues

-ExtensionRange
*?-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 (CodeSystem - Example Local Codes - Drug#Reaction conversion: Residual Starting Material 1 by HPLC)

QualifiedValues

-ExtensionRange
*?-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 above (ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72)

status: FINAL

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

subject: See above (Substance/fc178763-81c5-5656-9744-13c7ad1e595b)

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

performer: See above (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 above (ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72)

status: FINAL

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

subject: See above (Substance/fc178764-81d5-5656-9744-13c7ad1e595b)

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

performer: See above (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 above (ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72)

status: FINAL

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

subject: See above (Substance/fc178764-81d6-5656-9744-13c7ad1e595b)

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

performer: See above (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 above (ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d)

status: FINAL

code: ID by HPLC (CodeSystem - Example Local Codes - Drug#IDT "Identification")

subject: See above (Substance/fc178763-81c5-5656-9744-13c7ad1e595b)

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

performer: See above (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 above (ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d)

status: FINAL

code: ID by HPLC (CodeSystem - Example Local Codes - Drug#IDT "Identification")

subject: See above (Substance/fc178764-81d5-5656-9744-13c7ad1e595b)

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

performer: See above (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 above (ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d)

status: FINAL

code: ID by HPLC (CodeSystem - Example Local Codes - Drug#IDT "Identification")

subject: See above (Substance/fc178764-81d6-5656-9744-13c7ad1e595b)

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

performer: See above (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 above (ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72)

status: FINAL

code: Yield (%) (CodeSystem - Example Local Codes - Drug#Yield (%))

subject: See above (Substance/fc178763-81c5-5656-9744-13c7ad1e595b)

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

performer: See above (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 above (ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72)

status: FINAL

code: Yield (%) (CodeSystem - Example Local Codes - Drug#Yield (%))

subject: See above (Substance/fc178764-81d5-5656-9744-13c7ad1e595b)

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

performer: See above (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 above (ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72)

status: FINAL

code: Yield (%) (CodeSystem - Example Local Codes - Drug#Yield (%))

subject: See above (Substance/fc178764-81d6-5656-9744-13c7ad1e595b)

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

performer: See above (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 above (ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72)

status: FINAL

code: Yield (%) (CodeSystem - Example Local Codes - Drug#Yield (%))

subject: See above (Substance/fc178763-81c5-5656-9754-13c7ad1e595b)

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

performer: See above (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 above (ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72)

status: FINAL

code: Yield (%) (CodeSystem - Example Local Codes - Drug#Yield (%))

subject: See above (Substance/fc178764-81d5-5656-9764-13c7ad1e595b)

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

performer: See above (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 above (ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72)

status: FINAL

code: Yield (%) (CodeSystem - Example Local Codes - Drug#Yield (%))

subject: See above (Substance/fc178764-81d6-6656-9744-13c7ad1e595b)

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

performer: See above (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 above (ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72)

status: FINAL

code: ResidualWaterContent (w/w%) (CodeSystem - Example Local Codes - Drug#ResidualWaterContent "Residual Water Content (w/w%)")

subject: See above (Substance/fc178763-81c5-5656-9744-13c7ad1e595b)

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

performer: See above (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 above (ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72)

status: FINAL

code: ResidualWaterContent (w/w%) (CodeSystem - Example Local Codes - Drug#ResidualWaterContent "Residual Water Content (w/w%)")

subject: See above (Substance/fc178764-81d5-5656-9744-13c7ad1e595b)

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

performer: See above (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 above (ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72)

status: FINAL

code: ResidualWaterContent (w/w%) (CodeSystem - Example Local Codes - Drug#ResidualWaterContent "Residual Water Content (w/w%)")

subject: See above (Substance/fc178764-81d6-5656-9744-13c7ad1e595b)

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

performer: See above (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: id: 3003040516

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"

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"

Profile: SubstanceDefinition - Component Substance Drug PQ

manufacturer: See above (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 above (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: id: Start1Amgen

instance: true

Codes

-Reference
*See above (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: id: Start2Amgen

instance: true

Codes

-Reference
*See above (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: id: Start3Amgen

instance: true

Codes

-Reference
*See above (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 above (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 above (Substance/fc178762-81c5-5656-9744-13c7ad1e595b)

identifier: id: Intermed1Amgen

instance: true

Codes

-Reference
*See above (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 above (Substance/fc178762-81d5-5656-9744-13c7ad1e595b)

identifier: id: Intermed2Amgen

instance: true

Codes

-Reference
*See above (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 above (Substance/fc178762-81d5-5656-9744-23c7ad1e595b)

identifier: id: Intermed3Amgen

instance: true

Codes

-Reference
*See above (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 above (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: id: Start1Step2Amgen

instance: true

Codes

-Reference
*See above (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: id: Start2Step2Amgen

instance: true

Codes

-Reference
*See above (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: id: Start3Step2Amgen

instance: true

Codes

-Reference
*See above (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 above (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 above (Substance/fc178762-81c5-5656-9744-13c7ad2e595b)

identifier: id: Intermed1Step2Amgen

instance: true

Codes

-Reference
*See above (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 above (Substance/fc178762-81d5-5656-9744-13c7ad1e596b)

identifier: id: Intermed2Step2Amgen

instance: true

Codes

-Reference
*See above (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 above (Substance/fc178762-81d5-5656-9744-23c7ad1e597b)

identifier: id: Intermed3Step2Amgen

instance: true

Codes

-Reference
*See above (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: id: 3003040516

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 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: id: SUB1Amgen, id: SUB1SiteA

instance: true

Codes

-Reference
*See above (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 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: id: SUB2Amgen, id: SUB2SiteA

instance: true

Codes

-Reference
*See above (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 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: id: SUB3Amgen, id: SUB3SiteA

instance: true

Codes

-Reference
*See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)