Source | hl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0) |
resourceType | StructureDefinition |
id | pqcmc-product-batch-formula |
canonical | http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pqcmc-product-batch-formula |
version | 0.1.15 |
status | draft |
publisher | HL7 International - Biomedical Research and Regulatory WG |
name | BatchFormula |
title | Drug Product Batch Formula |
date | 2023-07-17T03:00:13+00:00 |
description | Listing of all components of the dosage form to be used in the manufacture, their amounts on a per batch basis, including overages, and reference to their quality standards. |
jurisdictions | us |
fhirVersion | 5.0.0 |
kind | resource |
abstract | false |
sdTtype | ManufacturedItemDefinition |
derivation | constraint |
base | http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition |
Usages |
|
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
ManufacturedItemDefinition | ManufacturedItemDefinition | |||
meta | ||||
profile | S | 1..1 | ||
identifier | S | ..1 | optional user designated identifier | |
status | S | |||
name | S | 1.. | Product Non-proprietary Name | |
manufacturer | S | Reference (Manufacturing and/or Test Site Organization) | ||
Slices for property | S | 2 .. | Slice: Unordered, Closed by value:type | |
property:BatchSize | S | 1..1 | ||
type | S |
Batch Quantity Required Pattern: At least the following |
||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: batchsize |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: Batch Quantity |
|
value[x] | Quantity | |||
unit | S | 1.. | Quantity UOM | |
code | S | 1.. | Binding: Units Of Measure Terminology ( required ) | |
property:BatchUtil | S | 1..* | ||
type | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: BatchUtil |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: Batch Utilization |
|
value[x] | S | 1.. | CodeableConcept | Batch Utilization |
coding | Binding: Batch utilization Terminology ( required ) | |||
property:AddInfo | S | 0..1 | ||
type | S | Required Pattern: At least the following | ||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: batchinfo |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: Batch Formula Additional Information |
|
value[x] | markdown | Batch Formula Additional Information | ||
component | S | 1.. | ||
type | S | Product Part Type | ||
constituent | S | 1.. | ||
Slices for extension | Slice: Unordered, Open by value:url | |||
additional-info | S | 0..1 | markdown |
Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-additional-info-extension |
formulaIngredient | S | 0..1 | (Complex) |
Product Batch Ingredient Extension
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-product-batch-ingredient-extension |
Slices for amount | S | 1 .. 2 | Slice: Unordered, Closed by value:code | |
amount:Weight | S C | 1..1 | cmc-percent-quantity: The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight | |
value | S | 1.. | Ingredient Quanty Per Batch Product Part | |
unit | S | 1.. | ||
code | S | 1.. | Binding: Units Of Measure Terminology ( required ) | |
amount:VolumeToVolume | S | 0..1 | ||
value | S | 1.. | Percent Ingredient Quanty Per Batch Product Part | |
code | 1.. | Required Pattern: C48571 | ||
amount:WeightToVolume | S | 0..1 | ||
value | S | 1.. | Percent Ingredient Quanty Per Batch Product Part | |
code | 1.. | Required Pattern: C48527 | ||
amount:WeightToWeight | S | 0..1 | ||
value | S | 1.. | Percent Ingredient Quanty Per Batch Product Part | |
code | 1.. | Required Pattern: C48528 | ||
location | S | Percent Product Part Ingredient Physical Location | ||
coding | Binding: Product Part Ingredient Physical Location value set ( required ) | |||
hasIngredient | S | 1..1 | CodeableReference (Drug Product Batch Formula Ingredient) | |
property | S | ..1 | BackboneElement | |
type | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: info |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: Product Part Additional Information |
|
value[x] | markdown | Drug Product Component Additional Information | ||
component | S | |||
Documentation for this format |
Produced 08 Sep 2023