Source | hl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0) |
resourceType | StructureDefinition |
id | pqcmc-batch-analysis |
canonical | http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pqcmc-batch-analysis |
version | 0.1.15 |
status | draft |
publisher | HL7 International - Biomedical Research and Regulatory WG |
name | BatchAnalysis |
title | Batch Analysis |
date | 2023-07-17T03:00:13+00:00 |
description | Batch or lot release testing to ensure that pharmaceutical products meet the product specification. |
jurisdictions | us |
fhirVersion | 5.0.0 |
kind | resource |
abstract | false |
sdTtype | DiagnosticReport |
derivation | constraint |
base | http://hl7.org/fhir/StructureDefinition/DiagnosticReport |
Usages |
|
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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) | ||
Documentation for this format |
Produced 08 Sep 2023