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

## Container Closure System: 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.6 Container Closure System.

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-container-closure-system-pq-ex2-sub
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-container-closure-system-pq
Type: collection
Found a parent (Ingredient/code, id: ingredient1 fullUrl: urn:uuid:f26b997a-3ab9-7552-a6cc-fd771d1f1863)
which is linked to this by resource.id
Substance - Stelbatolol [documentation R4 R5 R6]
id: substance1
fullUrl: urn:uuid:878c2849-792c-6469-21a2-c2b920930962
Name: Stelbatolol
Used as
Ingredient
[documentation R4 R5 R6]
id: ingredient1
fullUrl: urn:uuid:f26b997a-3ab9-7552-a6cc-fd771d1f1863
Status: active
Substance: Stelbatolol (SubstanceDefinition) id: substance1
For
Found a parent (PackagedProductDefinition/item, id: packageDefinition fullUrl: urn:uuid:b107a2ba-32d8-0124-7855-4096057c52a9)
which is linked to this by resource.id
Found a parent (PackagedProductDefinition/item, id: packageDefinition2 fullUrl: urn:uuid:b107a2ba-32d8-0124-7855-4096057c52b9)
which is linked to this by resource.id
Found a parent (Ingredient/for, id: ingredient1 fullUrl: urn:uuid:f26b997a-3ab9-7552-a6cc-fd771d1f1863)
which is linked to this by resource.id
Manufactured Item [documentation R4 R5 R6]
id: manufactureditemdefinition-drug-pq-ex1
fullUrl: urn:uuid:1531c777-50c3-047d-2798-de3d001d2c44
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ManufacturedItemDefinition-drug-pq
Status: active
Packaged in
Packaging - Bag [100000073493] (http://hl7.org/fhir/packaging-type)
Type: Bag [100000073493] (http://hl7.org/fhir/packaging-type)
Material: Low Density PolyEthylene [200000003216] (http://hl7.org/fhir/package-material)
Property
Type: Quality Specification [Quality Specification] (http://terminology.hl7.org/CodeSystem/package-property)
Value: Complies with FDA 21 CFR 177.1520 (c) 2.2 (olefin polymers)
Property
Type: Quality Specification [Quality Specification] (http://terminology.hl7.org/CodeSystem/package-property)
Value: Complies with Commission Regulation (EU) No. 10/2011 including its amendments EU 321/2011, EU 1282/2011, EU 1183/2012, EU 202/2014 and EU 2015/174 Complies with Ph. Eur. 3.2.2
Packaging - Bottle [100000073497] (http://hl7.org/fhir/packaging-type)
Type: Bottle [100000073497] (http://hl7.org/fhir/packaging-type)
Material: High Density PolyEthylene [200000003215] (http://hl7.org/fhir/package-material)
Table 1: Container Specification

Attribute | Analytical Procedure | Acceptance Criteria
--- | --- | ---
Container Type | Visual Inspection | Corresponds
Material Identification | Infrared Spectroscopy | Corresponds with reference
Material Conformity | Supplier Certificate of Analysis | Corresponds

Plan [documentation R4 R5 R6]
id: packagingSpecification-unlinked
fullUrl: urn:uuid:2138e4c7-22b8-4c56-2d28-6c077648763f
url (canonical): http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f
Title: Specification and Analytical Procedures
Description: Packaging components are sampled, tested, and examined for conformance with written specifications. The specification for the primary packaging component are provided in Table 1.
Type: Workflow Definition [workflow-definition] (http://terminology.hl7.org/CodeSystem/plan-definition-type), Container Specification [container-specification] (http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type)
Status: active
Subject: Packaged Product Definition (PackagedProductDefinition) id: packageDefinition
Action - Container Specification - Container Specification [Container Specification] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-specification-type-pq-example) - Text: Container Specification
Title: Container Specification
Code: Container Specification [Container Specification] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-specification-type-pq-example) - Text: Container Specification
Action - Test
Code: Test
Description: Container Type
Found a parent (PlanDefinition/action, id: packagingSpecification-unlinked 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 - VisualInspection [VisualInspection] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) [documentation R4 R5 R6]
id: VisualInspection
fullUrl: urn:uuid:64525b3c-5134-448a-9d19-939ce1958524
url (canonical): http://example-server.com/fhir/ObservationDefinition/64525b3c-5134-448a-9d19-939ce1958524
Title: Visual Inspection
Status: active
Code: VisualInspection [VisualInspection] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example)
Acceptable Value
Text: Corresponds
Action - Test
Code: Test
Description: Material Identification
Found a parent (PlanDefinition/action, id: packagingSpecification-unlinked 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 - InfraredSpectroscopy [InfraredSpectroscopy] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) [documentation R4 R5 R6]
id: InfraredSpectroscopy
fullUrl: urn:uuid:64525b3c-5134-448a-9d19-939ce1958525
url (canonical): http://example-server.com/fhir/ObservationDefinition/64525b3c-5134-448a-9d19-939ce1958525
Title: Infrared Spectroscopy
Status: active
Code: InfraredSpectroscopy [InfraredSpectroscopy] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example)
Acceptable Value
Text: Corresponds with reference
Action - Test
Code: Test
Description: Material Conformity
Found a parent (PlanDefinition/action, id: packagingSpecification-unlinked 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 - SupplierCertificateofAnalysis [SupplierCertificateofAnalysis] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) [documentation R4 R5 R6]
id: SupplierCertificateofAnalysis
fullUrl: urn:uuid:64525b3c-5134-448a-9d19-939ce1958535
url (canonical): http://example-server.com/fhir/ObservationDefinition/64525b3c-5134-448a-9d19-939ce1958535
Title: Supplier Certificate of Analysis
Status: active
Code: SupplierCertificateofAnalysis [SupplierCertificateofAnalysis] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example)
Acceptable Value
Text: Corresponds