Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan United States of America flag

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

Extension: Product Batch Ingredient Extension

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension Version: 2.0.0-ballot
Active as of 2024-12-04 Computable Name: ProductBatchIngredientExtension
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.41

Extension for measurement properties for ingredients in the batch formla.

Context of Use

This extension may be used on the following element(s):

  • Element ID ManufacturedItemDefinition.component.constituent

Usage info

Usage:

Formal Views of Extension Content

Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.

This structure is derived from Extension

Summary

Complex Extension: Extension for measurement properties for ingredients in the batch formla.

  • overagePercent: decimal: An Extension
  • overageJustification: markdown: An Extension

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Product Batch Ingredient Extension
... extension 2..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:overagePercent S 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "overagePercent"
..... value[x] 0..1 decimal Overage Percent
.... extension:overageJustification S 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "overageJustification"
..... value[x] 0..1 markdown Overage Justification
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension"

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Product Batch Ingredient Extension
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:overagePercent S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "overagePercent"
..... value[x] 0..1 decimal Overage Percent
.... extension:overageJustification S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "overageJustification"
..... value[x] 0..1 markdown Overage Justification
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: Extension for measurement properties for ingredients in the batch formla.

  • overagePercent: decimal: An Extension
  • overageJustification: markdown: An Extension

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Product Batch Ingredient Extension
... extension 2..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:overagePercent S 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "overagePercent"
..... value[x] 0..1 decimal Overage Percent
.... extension:overageJustification S 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "overageJustification"
..... value[x] 0..1 markdown Overage Justification
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension"

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Product Batch Ingredient Extension
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:overagePercent S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "overagePercent"
..... value[x] 0..1 decimal Overage Percent
.... extension:overageJustification S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "overageJustification"
..... value[x] 0..1 markdown Overage Justification
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension"

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()