Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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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 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: Overage Extension

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension Version: 2.0.0
Standards status: Trial-use Maturity Level: 2 Computable Name: OverageExtension
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.66

Extension for measurements related to excess for ingredients in the batch formula.

Context of Use

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

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Overage Extension
... extension 2..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:proportionDecimal SC 1..1 Extension Extension
overage-percent-limit: Overage percent must be less than 1.
..... extension 0..0
..... url 1..1 uri "proportionDecimal"
..... value[x] 0..1 decimal Overage Percent
.... extension:justification S 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "justification"
..... value[x] 0..1 markdown Overage Justification
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-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()
overage-percent-limiterrorExtension.extension:proportionDecimalOverage percent must be less than 1.
: extension('proportionDecimal').value.exists() implies extension('proportionDecimal').value < 1