Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

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

Drug Specification: 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.5.1 Specification(s).

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-drug-product-specification-pq-ex1
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-specification-pq
Type: collection
Plan [documentation R4 R5 R6]
id: plandefinition-drug-pq-ex3-drug-specification
fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a
url (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq
Title: SPECIFICATION(S) FOR DRUG PRODUCT
Description: Narrative description of specifications
Status: active
Subject
Product [documentation R4 R5 R6]
id: medicinalproductdefinition-drug-product-pq-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-pq-example)
Strength name part: 20mg
Description: Textual description of the product
Route of Administration: Oral use [20053000] (http://standardterms.edqm.eu)
Dose Form (combination of all parts): Gastro-resistant tablet [10225000] (http://standardterms.edqm.eu)
Ingredient - Active [100000072072] (http://hl7.org/fhir/ingredient-role)
[documentation R4 R5 R6]
id: productIngredient
fullUrl: urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6
Status: active
Role: Active [100000072072] (http://hl7.org/fhir/ingredient-role)
Substance
Found a parent (Ingredient/code, id: productIngredient fullUrl: urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6)
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
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: substance1 fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: substance-manufacturer
fullUrl: urn:uuid:9fe98cfa-9245-8313-0fc5-d15e613b5d6d
- AAA Molybdenum Products, Inc.
Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Molybdenum Products, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 7233 W 116th Pl, Ste C, Broomfield, Colorado, 80020, USA

Action: Specification(s) for Drug Product


Test ProcedureAcceptance Criteria Method Reference
Release End of shelf life
Description An orange film-coated tablet, debossed with 175 on one side As for release Visual inspection
Identification Consistent with the retention time and UV spectrum of the reference standard As for release ID by UHPLC
Assay 95% to 105% of label claim As for release Assay by UHPLC
Degradation Products
Impurity 1 NMT 0.2 % w/w NMT 0.8 % w/w Degradation products by UHPLC
Impurity 2 NMT 0.3 % w/w NMT 0.4 % w/w
Impurity 3 NMT 0.3 % w/w NMT 0.4 % w/w
Individual unspecified degradation products NMT 0.2 % w/w NMT 2.3 % w/w
Total degradation products NMT 1.4 % w/w NMT 2.3 % w/w
Dissolution Shall comply with the requirements of the harmonised USP/JP/Ph Eur Q=80% at 30 minutes As for release Apparatus 2 (paddles), UV measurement
Uniformity of dosage Shall comply with the requirements of the harmonised USP/JP/Ph Eur As for release Weight variation
Microbiological Shall comply with the requirements of the Ph Eur As for release Ph Eur
Water Content NMT 1.0 % w/w NMT 2.0 % w/w USP <921>

Action - Specification(s) for Drug Product - Overall set of actions
Title: Specification(s) for Drug Product
Code: Overall set of actions
Action - Release - Timing Group
Title: Release
Code: Timing Group
Timing
Code: Release time
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-drug-pq-ex3-drug-specification fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by canonical resource.url
Observation Definition - Description [DESC] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Description [documentation R4 R5 R6]
id: Description
fullUrl: urn:uuid:77e7020a-270c-6bed-2e55-28e9e942546c
url (canonical): http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c
Title: Description
Status: active
Code: Description [DESC] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Description
Method: Visual inspection
Acceptable Value
Text: An orange film-coated tablet, debossed with 175 on one side
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-drug-pq-ex3-drug-specification fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by canonical resource.url
Observation Definition - Identification [IDT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Identification [documentation R4 R5 R6]
id: Identification
fullUrl: urn:uuid:0d0ef4cf-242c-1cb1-81c4-c41837ee9a12
url (canonical): http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12
Title: Identification
Status: active
Code: Identification [IDT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Identification
Method: ID by UHPLC
Acceptable Value
Text: Consistent with the retention time and UV spectrum of the reference standard
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-drug-pq-ex3-drug-specification fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by canonical resource.url
Observation Definition - Assay [ASSAY] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Assay [documentation R4 R5 R6]
id: Assay
fullUrl: urn:uuid:c0f05343-5b98-6073-1a0f-873aaf4f59bc
url (canonical): http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc
Title: Assay
Status: active
Code: Assay [ASSAY] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Assay
Method: Assay by UHPLC
Acceptable Value
Text: 95% to 105% of label claim
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-drug-pq-ex3-drug-specification fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by canonical resource.url
Observation Definition - Degradation Products [DGP] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) [documentation R4 R5 R6]
id: Degradation
fullUrl: urn:uuid:a3d4d23a-800a-684a-6a47-fcfe44e06041
url (canonical): http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041
Title: Degradation Products
Status: active
Code: Degradation Products [DGP] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example)
Method: Degradation products by UHPLC
Acceptable Value
Applies To: Impurity 1
Range: to 0.2% w/w
Acceptable Value
Applies To: Impurity 2
Range: to 0.3% w/w
Acceptable Value
Applies To: Impurity 3
Range: to 0.3% w/w
Acceptable Value
Applies To: Individual unspecified degradation products
Range: to 0.2% w/w
Acceptable Value
Applies To: Total degradation products
Range: to 1.4% w/w
Component - Impurity [IMP] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example)
Code: Impurity [IMP] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example)
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-drug-pq-ex3-drug-specification fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by canonical resource.url
Observation Definition - Dissolution [Dissolution] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Dissolution [documentation R4 R5 R6]
id: Dissolution
fullUrl: urn:uuid:bb11322b-9470-4f13-91b5-c8a5253380eb
url (canonical): http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb
Title: Dissolution
Status: active
Code: Dissolution [Dissolution] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Dissolution
Method: Apparatus 2 (paddles), UV measurement
Acceptable Value
Text: Shall comply with the requirements of the harmonised USP/JP/Ph Eur Q=80% at 30 minutes
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-drug-pq-ex3-drug-specification fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by canonical resource.url
Observation Definition - uniformity of dosage units (by weight) [uniformity-dosage] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: uniformity of dosage units (by weight) [documentation R4 R5 R6]
id: Uniformity
fullUrl: urn:uuid:e7e2fe59-5433-5cc0-84b1-d5f30032790c
url (canonical): http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c
Title: Uniformity of dosage
Status: active
Code: uniformity of dosage units (by weight) [uniformity-dosage] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: uniformity of dosage units (by weight)
Method: Weight variation
Acceptable Value
Text: Shall comply with the requirements of the harmonised USP/JP/Ph Eur
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-drug-pq-ex3-drug-specification fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by canonical resource.url
Observation Definition - Microbiological Quality [Microbiological Quality] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Microbiological Quality [documentation R4 R5 R6]
id: Microbiological
fullUrl: urn:uuid:64972eb3-99ee-7eae-2f63-733e5ae84f71
url (canonical): http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71
Title: Microbiological
Status: active
Code: Microbiological Quality [Microbiological Quality] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Microbiological Quality
Method: Ph Eur
Acceptable Value
Text: Shall comply with the requirements of the Ph Eur
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-drug-pq-ex3-drug-specification fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by canonical resource.url
Observation Definition - Water Content [WaterContent] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Water Content [documentation R4 R5 R6]
id: Water
fullUrl: urn:uuid:6ce8ab6d-55e2-0412-5fb1-ab33763f30b1
url (canonical): http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1
Title: Water Content
Status: active
Code: Water Content [WaterContent] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Water Content
Method: USP <921>
Acceptable Value
Range: to 1.0% w/w
Action - End of shelf life - Timing Group
Title: End of shelf life
Code: Timing Group
Timing
Code: At end of shelf life
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-drug-pq-ex3-drug-specification fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by canonical resource.url
Observation Definition - Description [DESC] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Description [documentation R4 R5 R6]
id: DescriptionEnd
fullUrl: urn:uuid:d24ce3cd-213d-4935-97cf-8e2dd03721ec
url (canonical): http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec
Title: Description
Status: active
Code: Description [DESC] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Description
Acceptable Value
Text: As for release
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-drug-pq-ex3-drug-specification fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by canonical resource.url
Observation Definition - Identification [IDT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Identification [documentation R4 R5 R6]
id: IdentificationEnd
fullUrl: urn:uuid:f77ba972-5ef8-a178-9a5f-fe7f54da7499
url (canonical): http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499
Title: Identification
Status: active
Code: Identification [IDT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Identification
Acceptable Value
Text: As for release
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-drug-pq-ex3-drug-specification fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by canonical resource.url
Observation Definition - Assay [ASSAY] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Assay [documentation R4 R5 R6]
id: AssayEnd
fullUrl: urn:uuid:f4a74fd3-876e-38ce-021f-04e5a8fb6a3f
url (canonical): http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f
Title: Assay
Status: active
Code: Assay [ASSAY] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Assay
Acceptable Value
Text: As for release
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-drug-pq-ex3-drug-specification fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by canonical resource.url
Observation Definition - Degradation Products [DGP] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) [documentation R4 R5 R6]
id: DegradationEnd
fullUrl: urn:uuid:ef72eeb7-211a-3c16-8460-8725ca43584f
url (canonical): http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f
Title: Degradation Products
Status: active
Code: Degradation Products [DGP] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example)
Acceptable Value
Applies To: Impurity 1
Range: to 0.8% w/w
Acceptable Value
Applies To: Impurity 2
Range: to 0.4% w/w
Acceptable Value
Applies To: Impurity 3
Range: to 0.4% w/w
Acceptable Value
Applies To: Individual unspecified degradation products
Range: to 2.3% w/w
Acceptable Value
Applies To: Total degradation products
Range: to 2.3% w/w
Component - Impurity [IMP] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example)
Code: Impurity [IMP] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example)
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-drug-pq-ex3-drug-specification fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by canonical resource.url
Observation Definition - Dissolution [Dissolution] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Dissolution [documentation R4 R5 R6]
id: DissolutionEnd
fullUrl: urn:uuid:6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea
url (canonical): http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea
Title: Dissolution
Status: active
Code: Dissolution [Dissolution] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Dissolution
Method: Apparatus 2 (paddles), UV measurement
Acceptable Value
Text: As for release
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-drug-pq-ex3-drug-specification fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by canonical resource.url
Observation Definition - uniformity of dosage units (by weight) [uniformity-dosage] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: uniformity of dosage units (by weight) [documentation R4 R5 R6]
id: UniformityEnd
fullUrl: urn:uuid:43dbc2a3-00c4-6f79-6b11-63768b412aa3
url (canonical): http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3
Title: Uniformity of dosage
Status: active
Code: uniformity of dosage units (by weight) [uniformity-dosage] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: uniformity of dosage units (by weight)
Acceptable Value
Text: As for release
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-drug-pq-ex3-drug-specification fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by canonical resource.url
Observation Definition - Microbiological Quality [Microbiological Quality] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Microbiological Quality [documentation R4 R5 R6]
id: MicrobiologicalEnd
fullUrl: urn:uuid:e582e504-36ec-3b50-4043-51bf1147124e
url (canonical): http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e
Title: Microbiological
Status: active
Code: Microbiological Quality [Microbiological Quality] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Microbiological Quality
Method: Ph Eur
Acceptable Value
Text: As for release
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-drug-pq-ex3-drug-specification fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by canonical resource.url
Observation Definition - Water Content [WaterContent] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Water Content [documentation R4 R5 R6]
id: WaterEnd
fullUrl: urn:uuid:91391017-774b-5c77-93fa-642534278851
url (canonical): http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851
Title: Water Content
Status: active
Code: Water Content [WaterContent] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Water Content
Method: USP <921>
Acceptable Value
Range: to 2.0% w/w