Pharmaceutical Quality (Industry)
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This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Analytical Procedures: CMC synthetic data rendering - drug product

The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.2 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.

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Bundle [documentation R4 R5 R6]
id: bundle-analytical-procedure-pq-ex1-prod
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq
Type: collection
Product [documentation R4 R5 R6]
id: medicinalproductdefinition-drug-product-dxpq-ex1
fullUrl: urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
- Name: Stelbat Tablets, 20mg
Name type: Proprietary [Proprietary] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-local-pq)
Strength name part: 20mg
Route of Administration: Oral use [20053000] (http://standardterms.edqm.eu)
Dose Form (combination of all parts): Gastro-resistant tablet [10225000] (http://standardterms.edqm.eu)
↸arrow indicates that this PlanDefinition resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via PlanDefinition.subjectReference
Plan [documentation R4 R5 R6]
id: analyticalProcedure
fullUrl: urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f
url (canonical): http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f
Title: Analytical Procedure
Type: Workflow Definition [workflow-definition] (http://terminology.hl7.org/CodeSystem/plan-definition-type), Analytical Procedure [analytical-procedure] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-planType-local-pq)
Status: active
Action - Preparation and Analysis of Drug Product Samples
Title: Preparation and Analysis of Drug Product Samples
Participant
Role: Diluent [diluent] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq)
Display: Diluent
Found a parent (PlanDefinition/valueReference, id: analyticalProcedure fullUrl: urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763furl (canonical): http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f)
which is linked to this by resource.id
Substance - 0.05 % trifluoroacetic acid (TFA) in 50:50 acetonitrile: water (v/v) [documentation R4 R5 R6]
id: diluent
fullUrl: urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f81
Name: 0.05 % trifluoroacetic acid (TFA) in 50:50 acetonitrile: water (v/v)
Participant
Role: Resulting Material [ResultingMaterial] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq)
Display: Resulting material
Found a parent (PlanDefinition/valueReference, id: analyticalProcedure fullUrl: urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763furl (canonical): http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f)
which is linked to this by resource.id
Substance - Stelbat in Diluent (approximately 0.36 mg/mL) [documentation R4 R5 R6]
id: resultingMaterial
fullUrl: urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82
Name: Stelbat in Diluent (approximately 0.36 mg/mL)
Action - Sample Preparation
Title: Sample Preparation
Action - Instructions
Title: Instructions
Description: Transfer 5 tablets into a volumetric flask. Add a portion of the diluent and shake on mechanical shaker until tablets are completely disintegrated. Dilute to volume with diluent. Do not exceed 2 mg/mL in the initial dilution. Filter or centrifuge.
Action - Sample Analysis
Title: Sample Analysis
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: analyticalProcedure fullUrl: urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763furl (canonical): http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f)
which is linked to this by resource.id
Observation Definition -
(Data Absent Reason: unsupported)
 [documentation R4 R5 R6]
id: SampleAnalysis
fullUrl: urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e
url (canonical): http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e
Title: Sample Analysis
Status: active
Code:
(Data Absent Reason: unsupported)
Description: Number of Injections: 1 of each 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: 2 (only 1 is required for identity)
Type
Preference: preferred
Handling
Max Duration: 4 days
Instruction: at ambient or refrigerated conditions protected from light (may be extended with supporting data)
Member
Found a parent (ObservationDefinition/hasMember, id: SampleAnalysis 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 - Assay [ASSAY] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: Assay (w/w%) [documentation R4 R5 R6]
id: Assay
fullUrl: urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e
url (canonical): http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e
Text
Status: additional

Determine the amount of Stelbat in each sample replicate as follows:

formula

Where:

A SPL      =  Area of Stelbat in the sample

ANSR   =  Average normalized standard response factor of standard injections

DF     =  Overall sample dilution factor

N      = Number of tablets in sample preparation

Determine the % label claim of the sample as follows:

formula

Where:

LC       =          Label claim (mg/tablet) of tested sample

Title: Assay (w/w%)
Status: active
Code: Assay [ASSAY] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: Assay (w/w%)
Acceptable Value
Text: The %RSD between the two assay results must be ≤ 1.5%
Found a parent (ObservationDefinition/hasMember, id: SampleAnalysis 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 - Identification [IDT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: Identity [documentation R4 R5 R6]
id: Identity
fullUrl: urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e
url (canonical): http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e
Title: Identity
Status: active
Code: Identification [IDT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: Identity
Acceptable Value
Text: 1. The retention time ratio of the sample peak to standard peak is within 0.95 to 1.05.
Text: 2. The UV spectrum of the sample peak compares favorably to the UV spectrum of the standard peak from 210 nm to 400 nm.