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 - Manufacturing

Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-manufacturing-pq Version: 1.0.0
Active as of 2024-05-08 Computable Name: BundleProductManufacturingPq
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.18

Manufacturing Process domain: This Bundle profile represents the structured data used in CTD section 3.2.P.3 Manufacture, subsection 3.2.P.3.3 Description of Manufacturing Process and Process Controls and CTD section 3.2.S.2 Manufacture, subsection 3.2.S.2.2 Description of Manufacturing Process and Process Controls.

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-Definition 0..1 BackboneElement Entry in the bundle - will have a resource or information
..... resource 0..1 MedicinalProductDefinitionDrugProductPq Detailed definition of a medicinal product
.... entry:Drug-Ingredient 0..* BackboneElement Entry in the bundle - will have a resource or information
..... resource 0..1 IngredientDrugPq An ingredient of a manufactured item or pharmaceutical 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:Protocol 1..1 BackboneElement Entry in the bundle - will have a resource or information
..... resource 0..1 PlanDefinitionDrugPq The definition of a plan for a series of actions, independent of any specific patient or context
.... entry:Test-Device 1..* BackboneElement Entry in the bundle - will have a resource or information
..... resource 0..1 DeviceDefinitionDrugPq An instance of a medical-related component of a medical device
.... entry:Process-Diagram 1..* 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