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 – Product Compatibility

Bundle bundle-drug-product-compatibility-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"

> Profile: PlanDefinition - Drug PQ

> url: `http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f`

> title: Drug Product Compatibility

> type: Workflow Definition (PlanDefinitionType#workflow-definition; Pharmaceutical Plan Type Codes#product-compatibility "Product Compatibility")

> status: ACTIVE

> subject: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5

> description: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...

> > action

> > title: Results From Evaluation of Drug Product Compatibility With the Glass Syringe Using the Autoinjector/Pen

> > ### Actions

> > - | Code | Definition[x]
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958424
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958425

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

Resource DiagnosticReport:

> ## Product Compatibility Report

> When For | 2020-12

> Report Details

> Code | Value | When For
> SE-UHPLC Main Peak (%) |  | 2023-01-01 12:00:00+0000
> SE-UHPLC Main Peak (%) |  | 2023-01-01 12:00:00+0000
> SE-UHPLC HMW (%) |  | 2023-01-01 12:00:00+0000
> SE-UHPLC HMW (%) |  | 2023-01-01 12:00:00+0000
> CEX-HPLC Acidic Peak (%) |  | 2023-01-01 12:00:00+0000
> CEX-HPLC Acidic Peak (%) |  | 2023-01-01 12:00:00+0000
> CEX-HPLC Main Peak (%) |  | 2023-01-01 12:00:00+0000
> CEX-HPLC Main Peak (%) |  | 2023-01-01 12:00:00+0000

> The samples have been assessed and the conclusion is...

Entry 3 - fullUrl = urn:uuid:64525a3d-5034-448a-9c19-938ce1958424

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "64525a3d-5034-448a-9c19-938ce1958424"

> url: `http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424`

> title: SE-UHPLC % Main Peak

> status: ACTIVE

> code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")

> > component

> > code: SE-UHPLC Main Peak - 15 (Example Local Codes - Drug#SE-UHPLCMainPeak-15)

> > component

> > code: SE-UHPLC Main Peak - 25 (Example Local Codes - Drug#SE-UHPLCMainPeak-25)

Entry 4 - fullUrl = urn:uuid:64525a33-5034-448a-9c19-938ce1958424

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "64525a33-5034-448a-9c19-938ce1958424"

> url: `http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424`

> title: SE-UHPLC % HMW

> status: ACTIVE

> code: SE-UHPLC HMW (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")

> > component

> > code: SE-UHPLC HMW - 15 (Example Local Codes - Drug#SE-UHPLCHMW-15)

> > component

> > code: SE-UHPLC HMW - 25 (Example Local Codes - Drug#SE-UHPLCHMW-25)

Entry 5 - fullUrl = urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e8

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "54bb47fd-8964-4f96-6495-b2bec7f161e8"

> url: `http://example-server.com/fhir/ObservationDefinition/54bb47fd-8964-4f96-6495-b2bec7f161e8`

> title: CEX-HPLC % Acidic Peak

> status: ACTIVE

> code: CEX-HPLC Acidic Peak (%) (Example Local Codes - Drug#CEX-HPLCAcidicPeak "CEX-HPLC Acidic Peak")

> > component

> > code: CEX-HPLC Acidic Peak - 15 (Example Local Codes - Drug#CEX-HPLCAcidicPeak-15)

> > component

> > code: CEX-HPLC Acidic Peak - 25 (Example Local Codes - Drug#CEX-HPLCAcidicPeak-25)

Entry 6 - fullUrl = urn:uuid:74525a3d-5034-448a-9c19-938ce1958424

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "74525a3d-5034-448a-9c19-938ce1958424"

> url: `http://example-server.com/fhir/ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958424`

> title: CEX-HPLC % Main Peak

> status: ACTIVE

> code: CEX-HPLC Main Peak (%) (Example Local Codes - Drug#CEX-HPLCMainPeak "CEX-HPLC Main Peak")

> > component

> > code: CEX-HPLC Main Peak - 15 (Example Local Codes - Drug#CEX-HPLCMainPeak-15)

> > component

> > code: CEX-HPLC Main Peak - 25 (Example Local Codes - Drug#CEX-HPLCMainPeak-25)

Entry 7 - fullUrl = urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "44ba47fd-8964-4f96-6495-b2bec7f161e7"

> instantiates: See on this page: ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

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

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: SE-UHPLC Main Peak - 15 (Example Local Codes - Drug#SE-UHPLCMainPeak-15)

> > value: 8.5 %

> > component

> > code: SE-UHPLC Main Peak - 25 (Example Local Codes - Drug#SE-UHPLCMainPeak-25)

> > value: 9.5 %

Entry 8 - fullUrl = urn:uuid:54ca47fd-8964-4f96-6495-b2bec7f162e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54ca47fd-8964-4f96-6495-b2bec7f162e7"

> instantiates: See on this page: ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC Main Peak (%) (Example Local Codes - Drug#SE-UHPLCMainPeak "SE-UHPLC Main Peak")

> subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc

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

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: SE-UHPLC Main Peak - 15 (Example Local Codes - Drug#SE-UHPLCMainPeak-15)

> > value: 12.5 %

> > component

> > code: SE-UHPLC Main Peak - 25 (Example Local Codes - Drug#SE-UHPLCMainPeak-25)

> > value: 13.5 %

Entry 9 - fullUrl = urn:uuid:44ba47fd-8964-4f97-6495-b2bec7f161e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "44ba47fd-8964-4f97-6495-b2bec7f161e7"

> instantiates: See on this page: ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC HMW (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

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

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: SE-UHPLC HMW - 15 (Example Local Codes - Drug#SE-UHPLCHMW-15)

> > value: 73.0 %

> > component

> > code: SE-UHPLC HMW - 25 (Example Local Codes - Drug#SE-UHPLCHMW-25)

> > value: 79.0 %

Entry 10 - fullUrl = urn:uuid:54ca47fd-8964-4f98-6495-b2bec7f162e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54ca47fd-8964-4f98-6495-b2bec7f162e7"

> instantiates: See on this page: ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424

> status: FINAL

> code: SE-UHPLC HMW (%) (Example Local Codes - Drug#SE-UHPLCHMW "SE-UHPLC HMW")

> subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc

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

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: SE-UHPLC HMW - 15 (Example Local Codes - Drug#SE-UHPLCHMW-15)

> > value: 74.0 %

> > component

> > code: SE-UHPLC HMW - 25 (Example Local Codes - Drug#SE-UHPLCHMW-25)

> > value: 78.0 %

Entry 11 - fullUrl = urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54ba47fd-8964-4f96-6495-b2bec7f161e7"

> instantiates: See on this page: ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958424

> status: FINAL

> code: CEX-HPLC Main Peak (%) (Example Local Codes - Drug#CEX-HPLCMainPeak "CEX-HPLC Main Peak")

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

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

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: CEX-HPLC Main Peak - 15 (Example Local Codes - Drug#CEX-HPLCMainPeak-15)

> > value: 18.5 %

> > component

> > code: CEX-HPLC Main Peak - 25 (Example Local Codes - Drug#CEX-HPLCMainPeak-25)

> > value: 19.5 %

Entry 12 - fullUrl = urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54bb47fd-8964-4f96-6495-b2bec7f161e7"

> instantiates: See on this page: ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958424

> status: FINAL

> code: CEX-HPLC Main Peak (%) (Example Local Codes - Drug#CEX-HPLCMainPeak "CEX-HPLC Main Peak")

> subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc

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

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: CEX-HPLC Main Peak - 15 (Example Local Codes - Drug#CEX-HPLCMainPeak-15)

> > value: 15.5 %

> > component

> > code: CEX-HPLC Main Peak - 25 (Example Local Codes - Drug#CEX-HPLCMainPeak-25)

> > value: 16.5 %

Entry 13 - fullUrl = urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54ba47fd-8964-4f96-6495-b2bec7f161e8"

> instantiates: See on this page: ObservationDefinition/54bb47fd-8964-4f96-6495-b2bec7f161e8

> status: FINAL

> code: CEX-HPLC Acidic Peak (%) (Example Local Codes - Drug#CEX-HPLCAcidicPeak "CEX-HPLC Acidic Peak")

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

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

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: CEX-HPLC Acidic Peak (%) (Example Local Codes - Drug#CEX-HPLCAcidicPeak-15 "CEX-HPLC Acidic Peak - 15")

> > value: 28.5 %

> > component

> > code: CEX-HPLC Acidic Peak (%) (Example Local Codes - Drug#CEX-HPLCAcidicPeak-25 "CEX-HPLC Acidic Peak - 25")

> > value: 29.5 %

Entry 14 - fullUrl = urn:uuid:54ba48fd-8964-4f96-6495-b2bec7f161e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "54ba48fd-8964-4f96-6495-b2bec7f161e7"

> instantiates: See on this page: ObservationDefinition/54bb47fd-8964-4f96-6495-b2bec7f161e8

> status: FINAL

> code: CEX-HPLC Acidic Peak (%) (Example Local Codes - Drug#CEX-HPLCAcidicPeak "CEX-HPLC Acidic Peak")

> subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

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

> performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

> > component

> > code: CEX-HPLC Acidic Peak (%) (Example Local Codes - Drug#CEX-HPLCAcidicPeak-15 "CEX-HPLC Acidic Peak - 15")

> > value: 28.6 %

> > component

> > code: CEX-HPLC Acidic Peak (%) (Example Local Codes - Drug#CEX-HPLCAcidicPeak-25 "CEX-HPLC Acidic Peak - 25")

> > value: 29.3 %

Entry 15 - 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

> ### Names

> - | ProductName
> * | Stelbatolol

Entry 16 - fullUrl = urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

Resource Medication:

> Generated Narrative: Medication

> Resource Medication "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"

> code: ()

> ### Batches

> - | Extension | LotNumber
> * |  | 88877

Entry 17 - fullUrl = urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc

Resource Medication:

> Generated Narrative: Medication

> Resource Medication "a9dfda53-734b-045f-7ae4-94a6281d53bc"

> code: ()

> ### Batches

> - | Extension | LotNumber
> * |  | 88878

Entry 18 - 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