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

Resource Profile: Bundle - Impurities

Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-impurities-pq Version: 1.0.0
Active as of 2024-05-08 Computable Name: BundleProductImpuritiesPq
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.17

Impurities domain: This Bundle profile represents the structured data used in CTD section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.5 Characterisation of Impurities and CTD section 3.2.S.3 Characterisation, subsection 3.2.S.3.2 Impurities.

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from Bundle

NameFlagsCard.TypeDescription & Constraintsdoco
.. Bundle 0..* Bundle Contains a collection of resources
... identifier S 0..1 Identifier Persistent identifier for the bundle
... type S 1..1 code collection
Required Pattern: collection
... timestamp S 0..1 instant When the bundle was assembled
.... entry:Product-Identification 0..1 BackboneElement Entry in the bundle - will have a resource or information
..... resource 0..1 MedicinalProductDefinitionDrugProductPq Detailed definition of a medicinal product
.... entry:Component-Substance 1..* BackboneElement Entry in the bundle - will have a resource or information
..... resource 0..1 SubstanceDefinitionComponentSubstanceDrugPq The detailed description of a substance, typically at a level beyond what is used for prescribing
.... entry:Batch-Lot-Information 0..* BackboneElement Entry in the bundle - will have a resource or information
..... resource 0..1 MedicationBatchInformationDrugPq Definition of a Medication
.... entry:Report 0..* BackboneElement Entry in the bundle - will have a resource or information
..... resource 0..1 DiagnosticReportAnalysisDrugPQ A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
.... entry:Result-Observations 0..* BackboneElement Entry in the bundle - will have a resource or information
..... resource 0..1 ObservationTestResultDrugPq Measurements and simple assertions
.... entry:Process-Diagram 0..* BackboneElement Entry in the bundle - will have a resource or information
..... resource 0..1 DocumentReferenceDrugPq A reference to a document
.... entry:Organization 1..* BackboneElement Entry in the bundle - will have a resource or information
..... resource 0..1 OrganizationDrugPq A grouping of people or organizations with a common purpose

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron