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, product

Bundle bundle-product-process-validation-pq-ex1 of type collection

Entry 1 - fullUrl = urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f

Resource PlanDefinition:

> Generated Narrative: PlanDefinition

> Resource PlanDefinition "2038e4c7-22b8-4c56-2d28-6c077648763f"

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

> title: DP PROCESS VALIDATION

> type: Workflow Definition (PlanDefinitionType#workflow-definition; Pharmaceutical Plan Type Codes#process-validation "Process Validation")

> 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: Compounding Step

> > code: Compounding Step (Manufacturing Step Codes#compounding)

> > > action

> > action

> > title: Filling Steps

> > code: Filling Step (Manufacturing Step Codes#filling)

> > > action

> > action

> > title: Lyophilization Step

> > code: Lyophilization Step (Manufacturing Step Codes#lyophilization)

> > ### Actions

> > - | Code | Definition[x]
> > * | Conclusion () | http://example-server.com/fhir/ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/32e29d22-5fcb-546e-24fd-52a4a4004467
> > * | Homogeneity () | http://example-server.com/fhir/ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467
> > * | Homogeneity () | http://example-server.com/fhir/ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467

> > action

> > title: Release Step

> > code: Release Step (Manufacturing Step Codes#release)

> > > action

Entry 2 - fullUrl = urn:uuid:fc17b5d5-9fe1-91c2-2d06-47cb5b295e72

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"

> url: `http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72`

> title: pH (adjustment of pre-clarification bulk solution)

> status: ACTIVE

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

> ### QualifiedValues

> - | Range
> * | 6.9-7.1 pH

Entry 3 - fullUrl = urn:uuid:fc17b5d5-9fe1-91c2-2d06-47cb5b295e73

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"

> url: `http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73`

> title: pH (post-dilution bulk solution)

> status: ACTIVE

> code: pH (post-dilution bulk solution) (Example Local Codes - Drug#pH (post-dilution bulk solution))

> ### QualifiedValues

> - | Range
> * | 7.0-7.1 pH

Entry 4 - fullUrl = urn:uuid:fd17b5d5-9fe1-91c2-2d06-47cb5b295e72

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "fd17b5d5-9fe1-91c2-2d06-47cb5b295e72"

> url: `http://example-server.com/fhir/ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72`

> title: Assay (pre-clarification filtration) (mg/mL)

> status: ACTIVE

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

> ### QualifiedValues

> - | Range
> * | 22-? mg/mL

Entry 5 - fullUrl = urn:uuid:fd17b5d5-9fe1-91c2-2d06-47cb5b295e73

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "fd17b5d5-9fe1-91c2-2d06-47cb5b295e73"

> url: `http://example-server.com/fhir/ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73`

> title: Assay (Post dilution bulk solution) (mg/mL)

> status: ACTIVE

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

> ### QualifiedValues

> - | Range
> * | 20-21 mg/mL

Entry 6 - fullUrl = urn:uuid:fc07b5d5-9fe1-92c2-2d06-47cb5b295e72

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "fc07b5d5-9fe1-92c2-2d06-47cb5b295e72"

> url: `http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-47cb5b295e72`

> title: Appearance (Product Container, visual)

> status: ACTIVE

> code: Appearance (Product Container, visual) (Example Local Codes - Drug#Appearance (Product Container, visual))

> method: Visual inspection ()

> ### QualifiedValues

> - | Extension
> * |

Entry 7 - fullUrl = urn:uuid:fc07b5d5-9fe1-92c3-2d16-47cb5b295e72

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "fc07b5d5-9fe1-92c3-2d16-47cb5b295e72"

> url: `http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c3-2d16-47cb5b295e72`

> title: Appearance (Lyophilized, Visual)

> status: ACTIVE

> code: Appearance (Lyophilized, Visual) (Example Local Codes - Drug#Appearance (Lyophilized, Visual))

> method: Visual inspection ()

> ### QualifiedValues

> - | Extension
> * |

Entry 8 - fullUrl = urn:uuid:fc07b5d5-9fe1-92c3-2d06-47cb5b295e72

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "fc07b5d5-9fe1-92c3-2d06-47cb5b295e72"

> url: `http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c3-2d06-47cb5b295e72`

> title: Appearance (Reconstituted, Visual)

> status: ACTIVE

> code: Appearance (Reconstituted, Visual) (Example Local Codes - Drug#Appearance (Reconstituted, Visual))

> method: Visual inspection ()

> ### QualifiedValues

> - | Extension
> * |

Entry 9 - fullUrl = urn:uuid:3b0e878e-4bc9-8864-862f-e28b21233e8d

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "3b0e878e-4bc9-8864-862f-e28b21233e8d"

> url: `http://example-server.com/fhir/ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d`

> title: Identification

> status: ACTIVE

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

> method: ID by UHPLC ()

> ### QualifiedValues

> - | Extension
> * |

Entry 10 - fullUrl = urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "12e7e672-40a6-4036-3c1f-b8ba6a7d045e"

> url: `http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e`

> title: Assay

> status: ACTIVE

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

> method: Assay by UHPLC ()

> ### QualifiedValues

> - | Extension
> * |

Entry 11 - fullUrl = urn:uuid:8bdea820-4197-7c7d-0990-7be06bf78aaf

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "8bdea820-4197-7c7d-0990-7be06bf78aaf"

> url: `http://example-server.com/fhir/ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf`

> title: Degradation Products

> status: ACTIVE

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

> method: Degradation products by UHPLC ()

> > qualifiedValue

> > appliesTo: Impurity 1 ()

> > range: ?-0.2

> > qualifiedValue

> > appliesTo: Impurity 2 ()

> > range: ?-0.3

> > qualifiedValue

> > appliesTo: Impurity 3 ()

> > range: ?-0.3

> > qualifiedValue

> > appliesTo: Individual unspecified degradation products ()

> > range: ?-0.2

> > qualifiedValue

> > appliesTo: Total degradation products ()

> > range: ?-1.4

> ### Components

> - | Code
> * | Impurity (Example Local Codes - Drug#IMP)

Entry 12 - fullUrl = urn:uuid:31e29d22-5fcb-546e-24fd-52a4a4004467

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "31e29d22-5fcb-546e-24fd-52a4a4004467"

> url: `http://example-server.com/fhir/ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467`

> title: Water Content

> status: ACTIVE

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

> method: USP <921> ()

> ### QualifiedValues

> - | Range
> * | ?-1.0

Entry 13 - fullUrl = urn:uuid:32e29d22-5fcb-546e-24fd-52a4a4004467

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "32e29d22-5fcb-546e-24fd-52a4a4004467"

> url: `http://example-server.com/fhir/ObservationDefinition/32e29d22-5fcb-546e-24fd-52a4a4004467`

> title: Water Content

> status: ACTIVE

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

> method: USP <921> ()

> ### QualifiedValues

> - | Range
> * | ?-1.2

Entry 14 - fullUrl = urn:uuid:32e29d22-6fcb-546e-24fd-52a4a4004467

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "32e29d22-6fcb-546e-24fd-52a4a4004467"

> url: `http://example-server.com/fhir/ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467`

> title: Water Content

> status: ACTIVE

> code: Moisture (%) (Example Local Codes - Drug#WWWH "Water Content Homogeneity")

> ### QualifiedValues

> - | Extension | Range
> * |  | -1.5-1.5 % w/w

> > component

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

> > component

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

> > component

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

> > component

> > code: Was Homogeneity demonstrated? (Example Local Codes - Drug#Homogeneity "Homogeneity demonstrated")

Entry 15 - fullUrl = urn:uuid:32e29d32-6fcb-546e-24fd-52a4a4004467

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "32e29d32-6fcb-546e-24fd-52a4a4004467"

> url: `http://example-server.com/fhir/ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467`

> title: Assay

> status: ACTIVE

> code: Assay by HPLC (% Main Peak) (Example Local Codes - Drug#ASSH "Assay Content Homogeneity")

> ### QualifiedValues

> - | Extension | Range
> * |  | -2.3-2.3 %

> > component

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

> > component

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

> > component

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

> > component

> > code: Was Homogeneity demonstrated? (Example Local Codes - Drug#Homogeneity "Homogeneity demonstrated")

Entry 16 - fullUrl = urn:uuid:ef17cff1-6586-a5a4-9168-2602140548d7

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "ef17cff1-6586-a5a4-9168-2602140548d7"

> url: `http://example-server.com/fhir/ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d7`

> title: Uniformity of Dosage Units, Weight Variation - Meets USP / Ph. Eur. requirements (% label claim)

> status: ACTIVE

> code: Uniformity of Dosage Units, Weight Variation (Example Local Codes - Drug#Uniformity of Dosage Units, Weight Variation)

> method: Weight variation ()

> ### QualifiedValues

> - | Range
> * | 97-? %

Entry 17 - fullUrl = urn:uuid:ef17cff1-6586-a5a4-9168-2602140548d8

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "ef17cff1-6586-a5a4-9168-2602140548d8"

> url: `http://example-server.com/fhir/ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d8`

> title: Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)

> status: ACTIVE

> code: Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV) (Example Local Codes - Drug#Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV))

> method: Weight variation ()

> ### QualifiedValues

> - | Range
> * | ?-25

Entry 18 - fullUrl = urn:uuid:fc17b5d6-9fe1-91c2-2d06-47cb5b295e72

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "fc17b5d6-9fe1-91c2-2d06-47cb5b295e72"

> url: `http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d06-47cb5b295e72`

> title: pH (reconstituted)

> status: ACTIVE

> code: pH (reconstituted) (Example Local Codes - Drug#pH (reconstituted))

> ### QualifiedValues

> - | Range
> * | 6.95-7.05 pH

Entry 19 - fullUrl = urn:uuid:22515a3c-5034-448a-9c19-938ce1958424

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "22515a3c-5034-448a-9c19-938ce1958424"

> url: `http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424`

> title: Conclusion

> status: ACTIVE

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

Entry 20 - fullUrl = urn:uuid:64505a3c-5034-448a-9c19-938ce1958424

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "64505a3c-5034-448a-9c19-938ce1958424"

> url: `http://example-server.com/fhir/ObservationDefinition/64505a3c-5034-448a-9c19-938ce1958424`

> title: TAMC [a]

> status: ACTIVE

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

> ### QualifiedValues

> - | Range
> * | ?-10

Entry 21 - fullUrl = urn:uuid:64515a3c-5034-448a-9c19-938ce1958424

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "64515a3c-5034-448a-9c19-938ce1958424"

> url: `http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424`

> title: TYMC [a]

> status: ACTIVE

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

> ### QualifiedValues

> - | Range
> * | ?-10

Entry 22 - fullUrl = urn:uuid:64515a3c-5134-448a-9c19-938ce1958424

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "64515a3c-5134-448a-9c19-938ce1958424"

> url: `http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-938ce1958424`

> title: Fill Weight Average

> status: ACTIVE

> code: Fill Weight Average (Example Local Codes - Drug#Fill Weight Average)

> ### QualifiedValues

> - | Extension
> * |

Entry 23 - fullUrl = urn:uuid:64525a3c-5134-448a-9c19-938ce1958424

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "64525a3c-5134-448a-9c19-938ce1958424"

> url: `http://example-server.com/fhir/ObservationDefinition/64525a3c-5134-448a-9c19-938ce1958424`

> title: Fill Weight Target

> status: ACTIVE

> code: Fill Weight Target (g) (Example Local Codes - Drug#Fill Weight Target (g))

> ### QualifiedValues

> - | Extension
> * |

Entry 24 - fullUrl = urn:uuid:64515a3c-5134-448a-9c29-938ce1958424

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "64515a3c-5134-448a-9c29-938ce1958424"

> url: `http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c29-938ce1958424`

> title: Actual Avg. Weight from Target

> status: ACTIVE

> code: Actual Avg. Weight from Target (Example Local Codes - Drug#Actual Avg. Weight from Target)

> ### QualifiedValues

> - | Extension | Range
> * |  | 2-2 %

Entry 25 - fullUrl = urn:uuid:64515a3c-5234-448a-9c29-938ce1958424

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "64515a3c-5234-448a-9c29-938ce1958424"

> url: `http://example-server.com/fhir/ObservationDefinition/64515a3c-5234-448a-9c29-938ce1958424`

> title: Hold Time (filtration To filling)

> status: ACTIVE

> code: Hold Time (filtration To filling) (Example Local Codes - Drug#Hold Time (filtration To filling))

> ### QualifiedValues

> - | Range
> * | ?-2.5

Entry 26 - fullUrl = urn:uuid:64515a3c-5334-448a-9c29-938ce1958424

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "64515a3c-5334-448a-9c29-938ce1958424"

> url: `http://example-server.com/fhir/ObservationDefinition/64515a3c-5334-448a-9c29-938ce1958424`

> title: Hold Time (start filling to end filling)

> status: ACTIVE

> code: Hold Time (start filling to end filling) (Example Local Codes - Drug#Hold Time (start filling to end filling))

> ### QualifiedValues

> - | Range
> * | ?-1.25

Entry 27 - fullUrl = urn:uuid:64535a3c-5334-448a-9c29-938ce1958424

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "64535a3c-5334-448a-9c29-938ce1958424"

> url: `http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce1958424`

> title: Filter Integrity Test

> status: ACTIVE

> code: Filter Integrity Test (Example Local Codes - Drug#Filter Integrity Test)

> ### QualifiedValues

> - | Range
> * | 3.5-? psi

Entry 28 - fullUrl = urn:uuid:22525a3c-5034-448a-9c19-938ce1958424

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "22525a3c-5034-448a-9c19-938ce1958424"

> url: `http://example-server.com/fhir/ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424`

> title: Conclusion

> status: ACTIVE

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

Entry 29 - fullUrl = urn:uuid:64535a3c-5334-448a-9c29-938ce2958424

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "64535a3c-5334-448a-9c29-938ce2958424"

> url: `http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424`

> title: Lyophilizer Number

> status: ACTIVE

> code: Lyophilizer Number (Example Local Codes - Drug#Lyophilizer Number)

Entry 30 - fullUrl = urn:uuid:22e7e672-40a6-4036-3c1f-b8ba6a7d045e

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "22e7e672-40a6-4036-3c1f-b8ba6a7d045e"

> url: `http://example-server.com/fhir/ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e`

> title: Assay

> status: ACTIVE

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

> method: Assay by UHPLC ()

> ### QualifiedValues

> - | Extension | Range
> * |  | 95-105 %

> ### Components

> - | Code
> * | Number of Locations (Example Local Codes - Drug#LOC)

Entry 31 - fullUrl = urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51

Resource Medication:

> Generated Narrative: Medication

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

> Profile: Medication - Batch Information Drug PQ

> code: ()

> ### Batches

> - | Extension | LotNumber
> * | , , , , , , , , , | 33445

Entry 32 - fullUrl = urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc

Resource Medication:

> Generated Narrative: Medication

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

> code: ()

> ### Batches

> - | Extension | LotNumber
> * | , , , , , , , , , | 33446

Entry 33 - fullUrl = urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06

Resource Medication:

> Generated Narrative: Medication

> Resource Medication "c6f5fadd-62e6-3a01-93d9-b3b182f67d06"

> code: ()

> ### Batches

> - | Extension | LotNumber
> * | , , , , , , , , , | 33447

Entry 34 - fullUrl = urn:uuid:0102bca4-46c1-a6bf-1025-cd403fee710a

Resource Organization:

> Generated Narrative: Organization

> Resource Organization "0102bca4-46c1-a6bf-1025-cd403fee710a"

> identifier: `urn:oid:2.16.840.1.113883.4.82`/3010027650

> active: true

> type: Drug Product Manufacture (Pharmaceutical Organization Type Codes#drug-product-manufacture)

> name: AAA Pharmaceutical, Inc.

> ### Contacts

> - | Address
> * | 681 Main Street Lumberton New Jersey 08048 USA

Entry 35 - fullUrl = urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b07

Resource Organization:

> Generated Narrative: Organization

> Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b07"

> identifier: `urn:oid:2.16.840.1.113883.4.82`/3008816891

> active: true

> type: Packaging (Pharmaceutical Organization Type Codes#packaging)

> name: MySite

Entry 36 - 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 37 - fullUrl = urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd

Resource DiagnosticReport:

> ## Process Validation Report

> When For | 2020-12

> Report Details

> Code | Value | When For
> pH (adjustment of pre-clarification bulk solution) | 6.91 pH | 2023-01-01 12:00:00+0000
> pH (adjustment of pre-clarification bulk solution) | 6.92 pH | 2023-01-01 12:00:00+0000
> pH (adjustment of pre-clarification bulk solution) | 6.93 pH | 2023-01-01 12:00:00+0000
> pH (adjustment of pre-clarification bulk solution) | 7.01 pH | 2023-01-01 12:00:00+0000
> pH (adjustment of pre-clarification bulk solution) | 7.02 pH | 2023-01-01 12:00:00+0000
> pH (adjustment of pre-clarification bulk solution) | 6.93 pH | 2023-01-01 12:00:00+0000
> Assay (pre-clarification filtration) (mg/mL) | 21.1 mg/mL | 2023-01-01 12:00:00+0000
> Assay (pre-clarification filtration) (mg/mL) | 21.2 mg/mL | 2023-01-01 12:00:00+0000
> Assay (pre-clarification filtration) (mg/mL) | 21.3 mg/mL | 2023-01-01 12:00:00+0000
> Assay (Post dilution bulk solution) (mg/mL) | 20.1 mg/mL | 2023-01-01 12:00:00+0000
> Assay (Post dilution bulk solution) (mg/mL) | 20.2 mg/mL | 2023-01-01 12:00:00+0000
> Assay (Post dilution bulk solution) (mg/mL) | 20.3 mg/mL | 2023-01-01 12:00:00+0000
> Identification | Complies | 2023-01-01 12:00:00+0000
> Identification | Does not comply | 2023-01-01 12:00:00+0000
> Identification | Complies | 2023-01-01 12:00:00+0000
> Assay | 103 % | 2023-01-01 12:00:00+0000
> Assay | 102 % | 2023-01-01 12:00:00+0000
> Assay | 101 % | 2023-01-01 12:00:00+0000
> Degradation Products | 0.1 % w/w | 2023-01-01 12:00:00+0000
> Degradation Products | 0.2 % w/w | 2023-01-01 12:00:00+0000
> Degradation Products | 0.2 % w/w | 2023-01-01 12:00:00+0000
> Degradation Products | 0.2 % w/w | 2023-01-01 12:00:00+0000
> Degradation Products | 0.2 % w/w | 2023-01-01 12:00:00+0000
> Degradation Products | 0.2 % w/w | 2023-01-01 12:00:00+0000
> Degradation Products | 0.2 % w/w | 2023-01-01 12:00:00+0000
> Degradation Products | 0.2 % w/w | 2023-01-01 12:00:00+0000
> Degradation Products | 0.2 % w/w | 2023-01-01 12:00:00+0000
> Degradation Products | 0.1 % w/w | 2023-01-01 12:00:00+0000
> Degradation Products | 0.1 % w/w | 2023-01-01 12:00:00+0000
> Degradation Products | 0.1 % w/w | 2023-01-01 12:00:00+0000
> Degradation Products | 0.6 % w/w | 2023-01-01 12:00:00+0000
> Degradation Products | 0.7 % w/w | 2023-01-01 12:00:00+0000
> Degradation Products | 0.6 % w/w | 2023-01-01 12:00:00+0000
> Water Content | 0.5 % w/w | 2023-01-01 12:00:00+0000
> Water Content | 0.5 % w/w | 2023-01-01 12:00:00+0000
> Water Content | 0.5 % w/w | 2023-01-01 12:00:00+0000
> TAMC | 9.1 CFU/100ml | 2023-01-01 12:00:00+0000
> Conclusion | Conclusion of filling tests.... | 2023-01-01 12:00:00+0000
> Conclusion | Conclusion of lyophilization tests.... | 2023-01-01 12:00:00+0000
> Assay | 1234 | 2023-01-01 12:00:00+0000
> Assay | 1235 | 2023-01-01 12:00:00+0000
> Assay | 1236 | 2023-01-01 12:00:00+0000
> Assay | 97 % | 2023-01-01 12:00:00+0000
> Assay | 98 % | 2023-01-01 12:00:00+0000
> Assay | 96 % | 2023-01-01 12:00:00+0000
> Lyophilization Water Homogeneity |  | 2023-01-01 12:00:00+0000
> Lyophilization Assay Homogeneity |  | 2023-01-01 12:00:00+0000

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

Entry 38 - fullUrl = urn:uuid:f0a04328-905c-4ec5-372e-4d6cfef18629

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "f0a04328-905c-4ec5-372e-4d6cfef18629"

> instantiates: See on this page: ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d

> status: FINAL

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

> 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

> value: Complies ()

Entry 39 - fullUrl = urn:uuid:5e5a5e67-7fc6-0064-1be9-5d9d14d887e5

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "5e5a5e67-7fc6-0064-1be9-5d9d14d887e5"

> instantiates: See on this page: ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d

> status: FINAL

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

> 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

> value: Does not comply ()

Entry 40 - fullUrl = urn:uuid:cfde6776-673c-72e2-68c4-07b77cd85b74

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "cfde6776-673c-72e2-68c4-07b77cd85b74"

> instantiates: See on this page: ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d

> status: FINAL

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

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

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

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

> value: Complies ()

Entry 41 - fullUrl = urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56948a-2a39-6609-1c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72

> status: FINAL

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

> 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

> value: 6.91 pH (Details: UCUM code pH = 'pH')

Entry 42 - fullUrl = urn:uuid:9c56948a-3a39-6609-1c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56948a-3a39-6609-1c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72

> status: FINAL

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

> 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

> value: 6.92 pH (Details: UCUM code pH = 'pH')

Entry 43 - fullUrl = urn:uuid:9c56948a-4a39-6609-1c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56948a-4a39-6609-1c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72

> status: FINAL

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

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

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

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

> value: 6.93 pH (Details: UCUM code pH = 'pH')

Entry 44 - fullUrl = urn:uuid:9c56948a-3a49-6609-1c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56948a-3a49-6609-1c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73

> status: FINAL

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

> 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

> value: 7.01 pH (Details: UCUM code pH = 'pH')

Entry 45 - fullUrl = urn:uuid:9c56958a-4a39-6609-1c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56958a-4a39-6609-1c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73

> status: FINAL

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

> 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

> value: 7.02 pH (Details: UCUM code pH = 'pH')

Entry 46 - fullUrl = urn:uuid:9c56948a-5a39-6609-1c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56948a-5a39-6609-1c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73

> status: FINAL

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

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

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

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

> value: 6.93 pH (Details: UCUM code pH = 'pH')

Entry 47 - fullUrl = urn:uuid:9c56948a-2a39-6609-1c01-4d297ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56948a-2a39-6609-1c01-4d297ea57a33"

> instantiates: See on this page: ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72

> status: FINAL

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

> 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

> value: 21.1 mg/mL (Details: UCUM code mg/mL = 'mg/mL')

Entry 48 - fullUrl = urn:uuid:9c56948a-3a39-6619-1c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56948a-3a39-6619-1c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72

> status: FINAL

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

> 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

> value: 21.2 mg/mL (Details: UCUM code mg/mL = 'mg/mL')

Entry 49 - fullUrl = urn:uuid:9c56948a-4a39-6619-1c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56948a-4a39-6619-1c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72

> status: FINAL

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

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

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

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

> value: 21.3 mg/mL (Details: UCUM code mg/mL = 'mg/mL')

Entry 50 - fullUrl = urn:uuid:9c56948a-3a49-6619-1c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56948a-3a49-6619-1c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73

> status: FINAL

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

> 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

> value: 20.1 mg/mL (Details: UCUM code mg/mL = 'mg/mL')

Entry 51 - fullUrl = urn:uuid:9c56958a-4a39-6619-1c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56958a-4a39-6619-1c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73

> status: FINAL

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

> 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

> value: 20.2 mg/mL (Details: UCUM code mg/mL = 'mg/mL')

Entry 52 - fullUrl = urn:uuid:9c56948a-5a39-6709-1c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56948a-5a39-6709-1c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73

> status: FINAL

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

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

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

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

> value: 20.3 mg/mL (Details: UCUM code mg/mL = 'mg/mL')

Entry 53 - fullUrl = urn:uuid:9c56948a-1a39-6609-1c01-4d197ea57a33

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "9c56948a-1a39-6609-1c01-4d197ea57a33"

> instantiates: See on this page: ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e

> status: FINAL

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

> 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

> value: 103 % (Details: UCUM code % = '%')

Entry 54 - fullUrl = urn:uuid:1e20aed7-7626-1664-8d96-235f860d9a2c

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "1e20aed7-7626-1664-8d96-235f860d9a2c"

> instantiates: See on this page: ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e

> status: FINAL

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

> 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

> value: 102 % (Details: UCUM code % = '%')

Entry 55 - fullUrl = urn:uuid:ec6d7e30-4d70-491b-0669-a613eedd3c60

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "ec6d7e30-4d70-491b-0669-a613eedd3c60"

> instantiates: See on this page: ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e

> status: FINAL

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

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

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

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

> value: 101 % (Details: UCUM code % = '%')

Entry 56 - fullUrl = urn:uuid:ab7997fa-7b46-1175-3f01-6f6997f7878a

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "ab7997fa-7b46-1175-3f01-6f6997f7878a"

> instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf

> status: FINAL

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

> 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

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

> ### Components

> - | Code | Value[x]
> * | Impurity (Example Local Codes - Drug#IMP) | Impurity 1 ()

Entry 57 - fullUrl = urn:uuid:4052f28b-64a2-392d-35e4-ec8e912434d2

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "4052f28b-64a2-392d-35e4-ec8e912434d2"

> instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf

> status: FINAL

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

> 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

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

> ### Components

> - | Code | Value[x]
> * | Impurity (Example Local Codes - Drug#IMP) | Impurity 1 ()

Entry 58 - fullUrl = urn:uuid:34ebc51d-8105-0589-3c8d-e7aa6bd0a06c

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "34ebc51d-8105-0589-3c8d-e7aa6bd0a06c"

> instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf

> status: FINAL

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

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

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

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

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

> ### Components

> - | Code | Value[x]
> * | Impurity (Example Local Codes - Drug#IMP) | Impurity 1 ()

Entry 59 - fullUrl = urn:uuid:2940bf11-05bf-6ce2-3c64-457d0d1f9913

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "2940bf11-05bf-6ce2-3c64-457d0d1f9913"

> instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf

> status: FINAL

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

> 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

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

> ### Components

> - | Code | Value[x]
> * | Impurity (Example Local Codes - Drug#IMP) | Impurity 2 ()

Entry 60 - fullUrl = urn:uuid:332b1e76-6f70-2b4e-5d0c-f22a0e042d3e

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "332b1e76-6f70-2b4e-5d0c-f22a0e042d3e"

> instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf

> status: FINAL

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

> 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

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

> ### Components

> - | Code | Value[x]
> * | Impurity (Example Local Codes - Drug#IMP) | Impurity 2 ()

Entry 61 - fullUrl = urn:uuid:f0a13a3b-2e8b-594f-6874-6050511e4c57

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "f0a13a3b-2e8b-594f-6874-6050511e4c57"

> instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf

> status: FINAL

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

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

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

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

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

> ### Components

> - | Code | Value[x]
> * | Impurity (Example Local Codes - Drug#IMP) | Impurity 2 ()

Entry 62 - fullUrl = urn:uuid:7fe7ccd7-6449-0186-2282-3eeb4cf6a795

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "7fe7ccd7-6449-0186-2282-3eeb4cf6a795"

> instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf

> status: FINAL

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

> 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

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

> ### Components

> - | Code | Value[x]
> * | Impurity (Example Local Codes - Drug#IMP) | Impurity 3 ()

Entry 63 - fullUrl = urn:uuid:be016630-8754-7414-9014-21e020ad66c6

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "be016630-8754-7414-9014-21e020ad66c6"

> instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf

> status: FINAL

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

> 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

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

> ### Components

> - | Code | Value[x]
> * | Impurity (Example Local Codes - Drug#IMP) | Impurity 3 ()

Entry 64 - fullUrl = urn:uuid:92568f68-78f3-908c-6935-ff5f3d574dd6

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "92568f68-78f3-908c-6935-ff5f3d574dd6"

> instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf

> status: FINAL

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

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

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

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

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

> ### Components

> - | Code | Value[x]
> * | Impurity (Example Local Codes - Drug#IMP) | Impurity 3 ()

Entry 65 - fullUrl = urn:uuid:a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12"

> instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf

> status: FINAL

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

> 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

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

> ### Components

> - | Code | Value[x]
> * | Impurity (Example Local Codes - Drug#IMP) | Individual unspecified degradation products ()

Entry 66 - fullUrl = urn:uuid:d8533dcb-03f8-5997-6ccf-4f9b6f7a5745

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "d8533dcb-03f8-5997-6ccf-4f9b6f7a5745"

> instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf

> status: FINAL

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

> 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

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

> ### Components

> - | Code | Value[x]
> * | Impurity (Example Local Codes - Drug#IMP) | Individual unspecified degradation products ()

Entry 67 - fullUrl = urn:uuid:7cec19a2-34a7-6b80-3d60-083b2cc64fcb

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "7cec19a2-34a7-6b80-3d60-083b2cc64fcb"

> instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf

> status: FINAL

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

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

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

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

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

> ### Components

> - | Code | Value[x]
> * | Impurity (Example Local Codes - Drug#IMP) | Individual unspecified degradation products ()

Entry 68 - fullUrl = urn:uuid:27aa47fd-7964-4f96-6495-b2bec7f160e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "27aa47fd-7964-4f96-6495-b2bec7f160e7"

> instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf

> status: FINAL

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

> 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

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

> ### Components

> - | Code | Value[x]
> * | Impurity (Example Local Codes - Drug#IMP) | Total degradation products ()

Entry 69 - fullUrl = urn:uuid:6a78bcde-4781-226c-946e-a4b6915c1899

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "6a78bcde-4781-226c-946e-a4b6915c1899"

> instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf

> status: FINAL

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

> 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

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

> ### Components

> - | Code | Value[x]
> * | Impurity (Example Local Codes - Drug#IMP) | Total degradation products ()

Entry 70 - fullUrl = urn:uuid:f9f11088-7527-947c-3d3f-e71b32e13c78

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "f9f11088-7527-947c-3d3f-e71b32e13c78"

> instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf

> status: FINAL

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

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

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

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

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

> ### Components

> - | Code | Value[x]
> * | Impurity (Example Local Codes - Drug#IMP) | Total degradation products ()

Entry 71 - fullUrl = urn:uuid:66c2f585-678e-78b8-2235-1a3b37bd6e46

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "66c2f585-678e-78b8-2235-1a3b37bd6e46"

> instantiates: See on this page: ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467

> status: FINAL

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

> 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

> value: 0.5 % w/w (Details: UCUM code % = '%')

Entry 72 - fullUrl = urn:uuid:f8232d25-023d-679f-9c58-a6dc234b7a28

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "f8232d25-023d-679f-9c58-a6dc234b7a28"

> instantiates: See on this page: ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467

> status: FINAL

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

> 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

> value: 0.5 % w/w (Details: UCUM code % = '%')

Entry 73 - fullUrl = urn:uuid:368b82be-75dd-1d97-3dbc-a7eed9869daa

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "368b82be-75dd-1d97-3dbc-a7eed9869daa"

> instantiates: See on this page: ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467

> status: FINAL

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

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

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

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

> value: 0.5 % w/w (Details: UCUM code % = '%')

Entry 74 - fullUrl = urn:uuid:44aa47fd-8964-4f96-6495-b2bec7f160e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "44aa47fd-8964-4f96-6495-b2bec7f160e7"

> instantiates: See on this page: ObservationDefinition/64505a3c-5034-448a-9c19-938ce1958424

> status: FINAL

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

> 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

> value: 9.1 CFU/100ml

Entry 75 - fullUrl = urn:uuid:45aa47fd-8964-4f96-6495-b2bec7f160e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "45aa47fd-8964-4f96-6495-b2bec7f160e7"

> instantiates: See on this page: ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424

> status: FINAL

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

> subject: : all batches

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

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

> value: Conclusion of filling tests....

Entry 76 - fullUrl = urn:uuid:45ab47fd-8964-4f96-6495-b2bec7f160e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "45ab47fd-8964-4f96-6495-b2bec7f160e7"

> instantiates: See on this page: ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424

> status: FINAL

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

> subject: : all batches

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

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

> value: Conclusion of lyophilization tests....

Entry 77 - fullUrl = urn:uuid:37aa47fd-8964-4f96-6495-b2bec7f160e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "37aa47fd-8964-4f96-6495-b2bec7f160e7"

> instantiates: See on this page: ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424

> status: FINAL

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

> 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

> value: 1234

Entry 78 - fullUrl = urn:uuid:38aa47fd-8964-4f96-6495-b2bec7f160e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "38aa47fd-8964-4f96-6495-b2bec7f160e7"

> instantiates: See on this page: ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424

> status: FINAL

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

> 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

> value: 1235

Entry 79 - fullUrl = urn:uuid:38aa48fd-8964-4f96-6495-b2bec7f160e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "38aa48fd-8964-4f96-6495-b2bec7f160e7"

> instantiates: See on this page: ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424

> status: FINAL

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

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

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

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

> value: 1236

Entry 80 - fullUrl = urn:uuid:37aa47fd-7964-4f96-6495-b2bec7f160e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "37aa47fd-7964-4f96-6495-b2bec7f160e7"

> instantiates: See on this page: ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e

> status: FINAL

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

> 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

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

> ### Components

> - | Code | Value[x]
> * | Number of Locations (Example Local Codes - Drug#LOC) | 3

Entry 81 - fullUrl = urn:uuid:47aa47fd-7964-4f96-6495-b2bec7f160e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "47aa47fd-7964-4f96-6495-b2bec7f160e7"

> instantiates: See on this page: ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e

> status: FINAL

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

> 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

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

> ### Components

> - | Code | Value[x]
> * | Number of Locations (Example Local Codes - Drug#LOC) | 4

Entry 82 - fullUrl = urn:uuid:47aa47fd-7964-4f96-6495-b2bec7f160e8

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "47aa47fd-7964-4f96-6495-b2bec7f160e8"

> instantiates: See on this page: ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e

> status: FINAL

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

> subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06

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

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

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

> ### Components

> - | Code | Value[x]
> * | Number of Locations (Example Local Codes - Drug#LOC) | 2

Entry 83 - fullUrl = urn:uuid:47aa47fd-8964-4f96-6495-b2bec7f160e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "47aa47fd-8964-4f96-6495-b2bec7f160e7"

> instantiates: See on this page: ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467

> status: FINAL

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

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

> > value: Yes

> > component

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

> > value: 0.8 %

> > component

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

> > value: 0.9 %

> > component

> > code: Was Homogeneity demonstrated? (Example Local Codes - Drug#Homogeneity "Homogeneity demonstrated")

> > value: Yes

Entry 84 - fullUrl = urn:uuid:47aa47fd-8964-5f96-6495-b2bec7f160e7

Resource Observation:

> Generated Narrative: Observation

> Resource Observation "47aa47fd-8964-5f96-6495-b2bec7f160e7"

> instantiates: See on this page: ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467

> status: FINAL

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

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

> > value: No

> > component

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

> > value: Not calculated

> > component

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

> > value: Not calculated

> > component

> > code: Was Homogeneity demonstrated? (Example Local Codes - Drug#Homogeneity "Homogeneity demonstrated")

> > value: Yes

Entry 85 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5

Resource MedicinalProductDefinition:

> Generated Narrative: MedicinalProductDefinition

> Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"

> description: Textual description of the product

> combinedPharmaceuticalDoseForm: Gastro-resistant tablet (standardterms.edqm.eu#10225000)

> route: Oral use (standardterms.edqm.eu#20053000)

> > name

> > productName: Stelbat Tablets, 20mg

> > type: Proprietary (Product Name Type - example#Proprietary)

> > ### Parts

> > - | Part | Type
> > * | 20mg | Strength part (Product Name Part Type#StrengthPart)

Entry 86 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6

Resource Ingredient:

> Generated Narrative: Ingredient

> Resource Ingredient "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6"

> status: ACTIVE

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

> role: Active (Ingredient Role#100000072072)

> > substance

> > ### Codes

> > - | Reference
> > * | See on this page: SubstanceDefinition/6eb94d34-48b4-5bb0-4c05-e183d2ea3e95

Entry 87 - fullUrl = urn:uuid:6eb94d34-48b4-5bb0-4c05-e183d2ea3e95

Resource SubstanceDefinition:

> Generated Narrative: SubstanceDefinition

> Resource SubstanceDefinition "6eb94d34-48b4-5bb0-4c05-e183d2ea3e95"

> manufacturer: See on this page: Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2

> ### Names

> - | Name
> * | Stelbatolol

Entry 88 - fullUrl = urn:uuid:23dbbd32-2962-9fc3-40b1-67e864f21cd2

Resource Organization:

> Generated Narrative: Organization

> Resource Organization "23dbbd32-2962-9fc3-40b1-67e864f21cd2"

> identifier: `urn:oid:2.16.840.1.113883.4.82`/3003040516

> 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 89 - fullUrl = urn:uuid:57a9af63-315d-1585-a261-0e337b289390

Resource SubstanceDefinition:

> Generated Narrative: SubstanceDefinition

> Resource SubstanceDefinition "57a9af63-315d-1585-a261-0e337b289390"

> Profile: SubstanceDefinition - Component Substance Drug PQ

> manufacturer: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c

> ### Names

> - | Name
> * | Stelbatolol

Entry 90 - fullUrl = urn:uuid:49d2f0c0-4b28-9271-8aaf-2996a8b9739c

Resource Organization:

> Generated Narrative: Organization

> Resource Organization "49d2f0c0-4b28-9271-8aaf-2996a8b9739c"

> Profile: Organization - Drug PQ

> identifier: `urn:oid:2.16.840.1.113883.4.82`/3003040516

> 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 91 - fullUrl = urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a

Resource PlanDefinition:

> Generated Narrative: PlanDefinition

> Resource PlanDefinition "plandefinition-drug-pq-ex2-manufacturing-plan"

> Profile: PlanDefinition - Drug PQ

> Tag: http://terminology.hl7.org/CodeSystem/v3-ObservationValue

> Extension - History of Process PQ: This can be text about the history

> url: `http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a`

> title: Process 1.0

> type: Workflow Definition (PlanDefinitionType#workflow-definition; Pharmaceutical Plan Type Codes#manufacturing-process "Manufacturing Process")

> status: ACTIVE

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

> description: Narrative description of manufacturing process (5)

> > goal

> > > id

> > > goal-control-pH

> > category: Physical Property (Pharmaceutical Test Category Codes#C123456)

> > description: Controls - pH ()

> > priority: Critical (Goal Priority - example#critical)

> > ### Targets

> > - | Measure | Detail[x]
> > * | pH must be in range 6.9 to 7.1 (Example Local Codes - Drug#pH "pH") | 6.9-7.1 pH

> > goal

> > > id

> > > goal-control-water-content

> > category: Physical Property (Pharmaceutical Test Category Codes#C123456)

> > description: Controls - Water Content ()

> > priority: Critical (Goal Priority - example#critical)

> > ### Targets

> > - | Measure | Detail[x]
> > * | Under 2% (Example Local Codes - Drug#WaterContent "Water content") | ?-2

> > goal

> > > id

> > > goal-control-particle-size

> > category: Physical Property (Pharmaceutical Test Category Codes#C123456)

> > description: Controls - Particle Size ()

> > priority: Critical (Goal Priority - example#critical)

> > ### Targets

> > - | Measure | Detail[x]
> > * | Under 200 microns (Example Local Codes - Drug#particle-size "Particle Size") | ?-200

> > actor

> > ### Options

> > - | TypeReference | Role
> > * | See on this page: DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d | Mixing Vessel (Pharmaceutical Manufacturing Equipment Class Codes#mixing-vessel)

> > actor

> > ### Options

> > - | TypeReference | Role
> > * | See on this page: DeviceDefinition/82a39a18-91cf-b29d-76c1-a9e8bad9494d | Receiving Vessel (Pharmaceutical Manufacturing Equipment Class Codes#receiving-vessel)

Entry 92 - fullUrl = urn:uuid:82a39a18-91cf-a29d-76c1-a9e8bad9494d

Resource DeviceDefinition:

> Generated Narrative: DeviceDefinition

> Resource DeviceDefinition "82a39a18-91cf-a29d-76c1-a9e8bad9494d"

> ### DeviceNames

> - | Name | Type
> * | Mixing Vessel | REGISTEREDNAME

> ### Classifications

> - | Type
> * | Mixing Vessel (Device Type - example#mixing-vessel)

> ### Properties

> - | Type | Value[x]
> * | Capacity (Device Property Codes#Capacity) | 1000 litres

Entry 93 - fullUrl = urn:uuid:82a39a18-91cf-b29d-76c1-a9e8bad9494d

Resource DeviceDefinition:

> Generated Narrative: DeviceDefinition

> Resource DeviceDefinition "82a39a18-91cf-b29d-76c1-a9e8bad9494d"

> ### DeviceNames

> - | Name | Type
> * | Receiving Tank | REGISTEREDNAME

> ### Classifications

> - | Type
> * | Receiving Tank (Device Type - example#receiving-tank)

> ### Properties

> - | Type | Value[x]
> * | Capacity (Device Property Codes#Capacity) | 1200 litres

Entry 94 - fullUrl = urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b

Resource Substance:

> Generated Narrative: Substance

> Resource Substance "fc078762-81c5-5656-9744-13c7ad1e595b"

> Profile: Substance - Drug PQ

> > Medication Manufacturing Batch

> > > url

> > > `manufacturingDate`

> > value: 2019-09-07

> > > url

> > > `batchQuantity`

> > value: 5 kg

> > > url

> > > `batchUtilization`

> > value: Development (NCI Thesaurus#C133991)

> > > url

> > > `assignedManufacturer`

> > value: See 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: CAT1

> instance: true

> ### Codes

> - | Reference
> * | See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390

Entry 95 - fullUrl = urn:uuid:cb31d747-2338-88d5-342c-8e9c097e4dad

Resource Substance:

> Generated Narrative: Substance

> Resource Substance "cb31d747-2338-88d5-342c-8e9c097e4dad"

> > Medication Manufacturing Batch

> > > url

> > > `manufacturingDate`

> > value: 2019-09-07

> > > url

> > > `batchQuantity`

> > value: 5 kg

> > > url

> > > `batchUtilization`

> > value: Development (NCI Thesaurus#C133991)

> > > url

> > > `assignedManufacturer`

> > value: See 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: CAT2

> instance: true

> ### Codes

> - | Reference
> * | See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390

Entry 96 - fullUrl = urn:uuid:1551f97b-6f6d-825e-1fb3-44b0b090808c

Resource Substance:

> Generated Narrative: Substance

> Resource Substance "1551f97b-6f6d-825e-1fb3-44b0b090808c"

> > Medication Manufacturing Batch

> > > url

> > > `manufacturingDate`

> > value: 2019-09-07

> > > url

> > > `batchQuantity`

> > value: 5 kg

> > > url

> > > `batchUtilization`

> > value: Development (NCI Thesaurus#C133991)

> > > url

> > > `assignedManufacturer`

> > value: See 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: CAT3

> instance: true

> ### Codes

> - | Reference
> * | See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390