Generated Narrative: StructureDefinition pq-overage-extension Name Flags Card. Type Description & Constraints Extension <a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R5/conformance-rules.html#constraints" title="This element has or is affected by constraints ( cmc-overage-percent-limit )">C 0..* Extension Overage Extension Constraints: cmc-overage-percent-limit #xD; extension 2..* Extension Extension #xD; Slices for extension Content/Rules for all slices #xD; extension:proportionDecimal S 1..1 Extension Extension #xD; extension 0..0 #xD; url 1..1 uri "proportionDecimal" #xD; <a href="StructureDefinition-pq-overage-extension-definitions.html#Extension.extension:proportionDecimal.value[x]" title="Overage is the proportion of a drug substance in excess of the label claim to compensate for the loss, such as manufacturing or other.#xA;Note: This is not for stability loss, and generally not permitted.#xA;Example: 3% overage of drug that has a label claim of 10mg of active (API) - the formulation would have 10.3 mg. A batch formula for 100 kg would contain 103 kg of API.#xA;The value is entered as a decimal value less then one.">value[x] 0..1 decimal Overage Percent #xD; extension:justification S 1..1 Extension Extension #xD; extension 0..0 #xD; url 1..1 uri "justification" #xD; value[x] 0..1 markdown Overage Justification #xD; url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension" #xD; value[x] 0..0 #xD; Documentation for this format
HL7 International / Biomedical Research and Regulation
Extension for measurements related to excess for ingredients in the batch formula.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Must have either extensions or value[x], not both
extension.where(url='proportionDecimal').single().value < 1
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
Source of the definition for the extension code - a logical name or a URL.
The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Overage is the proportion of a drug substance in excess of the label claim to compensate for the loss, such as manufacturing or other. Note: This is not for stability loss, and generally not permitted. Example: 3% overage of drug that has a label claim of 10mg of active (API) - the formulation would have 10.3 mg. A batch formula for 100 kg would contain 103 kg of API. The value is entered as a decimal value less then one.
The rationale for use of excess drug substance during manufacturing of the drug product [Source: SME Defined]
Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R5/extensibility.html) for a list).