Pharmaceutical Quality (Industry)
1.0.0 - STU1

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

## Example Bundle: Example: Bundle - Process Validation, 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; 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

> > - | Code | Definition[x]
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9ff1-91c2-2d16-57cb5b295e72

> > action

> > title: Step 1 DS Release Testing Results

> > code: Step 1 DS Release Testing Results (Manufacturing Step Codes#Step1DSReleaseTestingResults)

> > ### Actions

> > - | Code | Definition[x]
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e

> > 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`/3003040516

> active: true

> type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#drug-substance-manufacture)

> name: AAA Molybdenum Products, Inc.

> ### Contacts

> - | Address
> * | 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA

Entry 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`/3007270600

> active: 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"

> Profile: SubstanceDefinition - Component Substance Drug PQ

> 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`/3003040516

> active: true

> type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#drug-substance-manufacture)

> name: AAA Molybdenum Products, Inc.

> ### Contacts

> - | Address
> * | 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA

Entry 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