Source | hl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0) |
resourceType | StructureDefinition |
id | drug-substance-manufacturing-batch |
canonical | http://hl7.org/fhir/us/pq-cmc/StructureDefinition/drug-substance-manufacturing-batch |
version | 0.1.15 |
status | draft |
publisher | HL7 International - Biomedical Research and Regulatory WG |
name | DrugSubstancemanufacturingBatch |
title | Drug Substance Manufacturing Batch |
date | 2023-07-17T03:00:13+00:00 |
description | This profile defines the details of a batch of API. |
jurisdictions | us |
fhirVersion | 5.0.0 |
kind | complex-type |
abstract | false |
sdTtype | Extension |
derivation | constraint |
base | http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch |
contexts | element:Substance |
Usages |
|
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Extension | MedManufacturingBatch | |||
extension | 7.. | |||
extension:manufacturingDate | S | 1.. | Manufacturing Date | |
value[x] | S | |||
extension:manufacturingDateClassification | S | 1.. | Manufacturing Date Description | |
value[x] | S | |||
extension:assignedManufacturer | S | 1.. | Assigned Manufacturer | |
value[x] | Reference (Manufacturing and/or Test Site Organization) | |||
extension:expirationDateClassification | S | 1.. | Retest Date Classification | |
value[x] | S | Binding: Retest Date Classification Terminology ( required ) | ||
extension:batchUtilization | S | 1.. | Batch Utilization | |
value[x] | S | Binding: Batch utilization Terminology ( required ) | ||
extension:batchQuantity | S | 1.. | Batch Size | |
value[x] | S | |||
extension:additionalInformation | S | Additional Information | ||
extension:container | S | 1.. | Container | |
extension | 4.. | |||
extension:lotNumber | Container Lot Number | |||
value[x] | S | |||
extension:type | S | 1.. | Container Type | |
value[x] | S | Binding: Container Type Terminology ( required ) | ||
extension:quantity | S | 1.. | Container Fill per Container Size | |
value[x] | S | |||
extension:closureSystemDescription | S | 1.. | Container Closure System Description | |
value[x] | S | |||
extension:closureType | S | 1.. | Closure Type | |
value[x] | S | Binding: Closure Type Terminology ( required ) | ||
Documentation for this format |
Produced 08 Sep 2023