StructureDefinition-pqcmc-batch-analysis

Sourcehl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0)
resourceTypeStructureDefinition
idpqcmc-batch-analysis
canonicalhttp://hl7.org/fhir/us/pq-cmc/StructureDefinition/pqcmc-batch-analysis
version0.1.15
statusdraft
publisherHL7 International - Biomedical Research and Regulatory WG
nameBatchAnalysis
titleBatch Analysis
date2023-07-17T03:00:13+00:00
descriptionBatch or lot release testing to ensure that pharmaceutical products meet the product specification.
jurisdictionsus
fhirVersion5.0.0
kindresource
abstractfalse
sdTtypeDiagnosticReport
derivationconstraint
basehttp://hl7.org/fhir/StructureDefinition/DiagnosticReport
Usages
Name Flags Card. Type Description & Constraints doco
. . DiagnosticReport DiagnosticReport
. . . Slices for extension 1.. Slice: Unordered, Open by value:url
. . . qualitySpecification S 1..1 (Complex) Specification and Specification Version
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-quality-specification-extension
. . . identifier S ..1 optional user designated identifier
. . . status S Status of the batch analysis
. . . code S Name for this batch analysis.
. . . . coding .. 0
. . . . text S 1..
. . . subject S 1.. Reference (Drug Product Manufactured Instance | Drug Substance Manufactured Batch) A single medication batch/lot or a single subtance batch/lot
. . . Slices for effective[x] 1 .. Slice: Unordered, Open by type:$this
. . . . effective[x]:effectiveDateTime S 1..1 dateTime Batch Analysis Release Date
. . . performer S 1..1 Reference (Manufacturing and/or Test Site Organization) Test Site
. . . result S Reference (Result Observation)

doco Documentation for this format

Produced 08 Sep 2023