Pharmaceutical Quality (Industry)
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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

Analytical Procedures: synthetic data rendering - drug substance

The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, section 3.2.S.4 Control of Drug Substance, subsection 3.2.S.4.2 Analytical Procedures.

This is the same data as in the example files here in xml and in json, presented for easier viewing. Hovering on words below will show the corresponding sections of the underlying data.

Bundle [documentation R4 R5 R6]
id: bundle-analytical-procedure-pq-ex2-sub
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq
Type: collection
Found a parent (PlanDefinition/subjectReference, id: analyticalProcedure fullUrl: urn:uuid:2138e4c7-22b8-4c56-2d28-6c077648763furl (canonical): http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f)
which is linked to this by resource.id
Substance - Stelbatolol [documentation R4 R5 R6]
id: substance1
fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152
Name: Stelbatolol
↸arrow indicates that this PlanDefinition resource points back to the parent SubstanceDefinition, instead of being linked forwards from it - via PlanDefinition.subjectReference
Plan [documentation R4 R5 R6]
id: analyticalProcedure
fullUrl: urn:uuid:2138e4c7-22b8-4c56-2d28-6c077648763f
url (canonical): http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f
Title: Analytical Procedure
Type: Workflow Definition [workflow-definition] (http://terminology.hl7.org/CodeSystem/plan-definition-type), Analytical Procedure [analytical-procedure] (http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type)
Status: active
Action - Determination of Particle Size of Stelbat by Laser Diffraction (G1112)
Title: Determination of Particle Size of Stelbat by Laser Diffraction (G1112)
Parameters
Parameter: Optical properties [OPTICAL] (http://terminology.hl7.org/CodeSystem/process-parameter)
Value Text: Same as for blue light
Parameters
Parameter: Theory [THEORY] (http://terminology.hl7.org/CodeSystem/process-parameter)
Value Text: MIE
Parameters
Parameter: Stir Time [STIR] (http://terminology.hl7.org/CodeSystem/process-parameter)
Value Quantity: 1 minute
Participant
Role: Dispersant [dispersant] (http://terminology.hl7.org/CodeSystem/manufacturing-participant-role)
Display: Dispersant
Found a parent (PlanDefinition/valueReference, id: analyticalProcedure fullUrl: urn:uuid:2138e4c7-22b8-4c56-2d28-6c077648763furl (canonical): http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f)
which is linked to this by resource.id
Substance - 0.1% Sorbitan monooleate (Span 80) in hexanes (m/v) [documentation R4 R5 R6]
id: dispersant
fullUrl: urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8135565f82
Name: 0.1% Sorbitan monooleate (Span 80) in hexanes (m/v)
Property
Type: Shelf life
Value: Refer to local laboratory expiration date (may be extended with supporting data)
Participant
Role: Resulting Material [ResultingMaterial] (http://terminology.hl7.org/CodeSystem/manufacturing-participant-role)
Display: Resulting material
Found a parent (PlanDefinition/valueReference, id: analyticalProcedure fullUrl: urn:uuid:2138e4c7-22b8-4c56-2d28-6c077648763furl (canonical): http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f)
which is linked to this by resource.id
Substance - Stelbat in dispersant (approximately 10 mg/mL) [documentation R4 R5 R6]
id: resultingMaterial
fullUrl: urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82
Name: Stelbat in dispersant (approximately 10 mg/mL)
Action - Sample Preparation
Title: Sample Preparation
Action - Instructions
Title: Instructions
Description: Vortex approximately 30 seconds. Mix briefly by vortexing immediately before use.
Action - Sample Analysis
Title: Sample Analysis
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: analyticalProcedure fullUrl: urn:uuid:2138e4c7-22b8-4c56-2d28-6c077648763furl (canonical): http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f)
which is linked to this by canonical resource.url
Observation Definition -
(Data Absent Reason: unsupported)
 [documentation R4 R5 R6]
id: ParticleSize
fullUrl: urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e
url (canonical): http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e
Title: Particle Size
Status: active
Code:
(Data Absent Reason: unsupported)
Description: Number of Analyses: 1 replicate for each sample preparation
Specimen
Specimen Definition
 [documentation R4 R5 R6]
id: specimendefinition
fullUrl: urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2
url (canonical): http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2
Status: active
Description: Number of Preparations: 3
Device
Found a parent (ObservationDefinition/device, id: ParticleSize fullUrl: urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046eurl (canonical): http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e)
which is linked to this by resource.id
Device [documentation R4 R5 R6]
id: laser
fullUrl: urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9495c
Description: Analyzer with disperser and temperature control accessory, or equivalent
Type: Particle Size Analyzer with Laser Diffraction
Member
Found a parent (ObservationDefinition/hasMember, id: ParticleSize fullUrl: urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046eurl (canonical): http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e)
which is linked to this by resource.id
Observation Definition - Obscuration [Obscuration] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Obscuration (%) [documentation R4 R5 R6]
id: ParticleSizeObscuration
fullUrl: urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e
url (canonical): http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e
Title: Obscuration
Status: active
Code: Obscuration [Obscuration] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Obscuration (%)
Acceptable Value
Range: from 10% to 30%
Target: 15%
Found a parent (ObservationDefinition/hasMember, id: ParticleSize fullUrl: urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046eurl (canonical): http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e)
which is linked to this by resource.id
Observation Definition - Refractive index [Refractive index] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Particle refractive index [documentation R4 R5 R6]
id: ParticleRI
fullUrl: urn:uuid:12e7e672-41a6-4036-3c1f-b8ba6a7d045e
url (canonical): http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e
Title: Particle refractive index
Status: active
Code: Refractive index [Refractive index] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Particle refractive index
Acceptable Value
Range: from 1.75 to 1.75
Found a parent (ObservationDefinition/hasMember, id: ParticleSize fullUrl: urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046eurl (canonical): http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e)
which is linked to this by resource.id
Observation Definition - Particle Size RSD [Particle Size RSD] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Particle Size RSD [documentation R4 R5 R6]
id: ParticleSizeRSD
fullUrl: urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e
url (canonical): http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e
Title: Particle Size RSD
Status: active
Code: Particle Size RSD [Particle Size RSD] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Particle Size RSD
Acceptable Value
Text: The %RSD for the D(v, 0.9) must be not more than 15%
Action - Sample Calculation - Calculation
Title: Sample Calculation
Code: Calculation
Description: The particle size result is calculated automatically by the instrument software for each sample.
Action - Reporting - Reporting
Title: Reporting
Code: Reporting
Description: Report the average value as per specification