Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

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 – Analytical Procedure, substance

Bundle bundle-analytical-procedure-pq-ex2-sub of type collection

Entry 1 - fullUrl = urn:uuid:2138e4c7-22b8-4c56-2d28-6c077648763f

Resource PlanDefinition:

Generated Narrative: PlanDefinition

Resource PlanDefinition "analyticalProcedure"

url: http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f

title: Analytical Procedure

type: Workflow Definition (PlanDefinitionType#workflow-definition; Pharmaceutical Plan Type Codes#analytical-procedure "Analytical Procedure")

status: ACTIVE

subject: See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152

action

Extension - Process Parameters PQ

url

parameter

value: Optical properties (Process Parameter Codes#OPTICAL)

url

valueText

value: Same as for blue light

Extension - Process Parameters PQ

url

parameter

value: Theory (Process Parameter Codes#THEORY)

url

valueText

value: MIE

Extension - Process Parameters PQ

url

parameter

value: Stir Time (Process Parameter Codes#STIR)

url

value

value: 1 minute

title: Determination of Particle Size of Stelbat by Laser Diffraction (G1112)

participant

typeReference: : Dispersant

role: Dispersant (Manufacturing Participant Role Codes#dispersant)

participant

typeReference: : Resulting material

role: Resulting Material (Manufacturing Participant Role Codes#ResultingMaterial)

action

action

action

action

Entry 2 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821152"

Names

-Name
*Stelbatolol

Entry 3 - fullUrl = urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8135565f82

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "9f69ec9c-5fd1-30d2-0790-9e8135565f82"

Properties

-TypeValue[x]
*Shelf life ()Refer to local laboratory expiration date (may be extended with supporting data) ()

Names

-Name
*0.1% Sorbitan monooleate (Span 80) in hexanes (m/v)

Entry 4 - fullUrl = urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "9f69ec9c-5fd1-30d2-0790-9e8035565f82"

Names

-Name
*Stelbat in dispersant (approximately 10 mg/mL)

Entry 5 - fullUrl = urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "12e7e672-40a6-4136-3c1f-b8ba6a7d046e"

url: http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e

title: Particle Size

status: ACTIVE

description: Number of Analyses: 1 replicate for each sample preparation

code: ()

specimen: See on this page: SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2

device: See on this page: DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9495c

hasMember:

Entry 6 - 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: Obscuration

status: ACTIVE

code: Obscuration (%) (Example Local Codes - Drug#Obscuration "Obscuration")

QualifiedValues

-Range
*10-30 %

Entry 7 - fullUrl = urn:uuid:12e7e672-41a6-4036-3c1f-b8ba6a7d045e

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "12e7e672-41a6-4036-3c1f-b8ba6a7d045e"

url: http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e

title: Particle refractive index

status: ACTIVE

code: Particle refractive index (Example Local Codes - Drug#Refractive index "Refractive index")

QualifiedValues

-Range
*1.75-1.75

Entry 8 - fullUrl = urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "12e7e672-40a6-4036-3c1f-b8ba6a7d046e"

url: http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e

title: Particle Size RSD

status: ACTIVE

code: Particle Size RSD (Example Local Codes - Drug#Particle Size RSD)

QualifiedValues

-Extension
*

Entry 9 - fullUrl = urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2

Resource SpecimenDefinition:

Generated Narrative: SpecimenDefinition

Resource SpecimenDefinition "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"

url: http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2

status: ACTIVE

description: Number of Preparations: 3

Entry 10 - fullUrl = urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9495c

Resource DeviceDefinition:

Generated Narrative: DeviceDefinition

Resource DeviceDefinition "82a39a18-91cf-a19d-76c1-a9e8bad9495c"

description: Analyzer with disperser and temperature control accessory, or equivalent

Classifications

-Type
*Particle Size Analyzer with Laser Diffraction ()