Union of http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part and http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part

This is the set of resources that conform to either of the profiles Manufactured Drug Product (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part) and Manufactured Drug Product (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part). E.g. what you have to deal with if you get resources conforming to one of them

Structure

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ManufacturedItemDefinition C0..*The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
Constraints: cmc-capsule-count-required, cmc-arbitrary-unit-text-required, cmc-coating-indication-required, cmc-tablet-layer-count-required, cmc-tablet-bead-count-required, cmc-capsule-classification-required, cmc-component-id-ref
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: ?? (required): IETF language tag for a human language
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... identifier SΣ0..1IdentifierUnique identifier
... status ?!SΣ1..1codedraft | active | retired | unknown
Binding: ?? (required): The lifecycle status of an artifact.
... name SΣ0..1stringProduct Proprietary Name | Product Non-proprietary Name
... manufacturedDoseForm Σ1..1CodeableConceptDose form as manufactured (before any necessary transformation)
Binding: ?? (required)
... unitOfPresentation Σ0..1CodeableConceptThe “real-world” units in which the quantity of the item is described
Binding: ?? (example): The presentation type in which an administrable medicinal product is given to a patient.
... manufacturer Σ0..*Reference(Organization)Manufacturer of the item, one of several possible
... marketingStatus Σ0..*MarketingStatusAllows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
... ingredient Σ0..*CodeableConceptThe ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource
Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
... property SΣ6..*BackboneElementGeneral characteristics of this item
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type SΣ1..1CodeableConceptA code expressing the type of characteristic
Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
..... extension 0..*ExtensionAdditional content defined by implementations
..... coding Σ0..*CodingCode defined by a terminology system
..... text SΣ1..1stringPlain text representation of the concept
.... value[x] Σ0..1A value for the characteristic
..... valueCodeableConceptCodeableConcept
..... valueQuantityQuantity
..... valueDatedate
..... valueBooleanboolean
..... valueMarkdownmarkdown
..... valueAttachmentAttachment
..... valueReferenceReference(Binary)
... component SΣC1..*BackboneElementPhysical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup
Constraints: cmc-amount-ratio-or-quantity
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtension
.... type SΣ1..1CodeableConceptProduct Part Type
..... extension 0..*ExtensionAdditional content defined by implementations
..... coding Σ0..*CodingCode defined by a terminology system
Binding: ?? (required)
..... text Σ0..1stringPlain text representation of the concept
.... function S0..*??Product Part Function Description
.... amount SΣ0..2QuantityThe measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
.... constituent SΣC1..*BackboneElementProduct Part Ingredient Component Function Category
Constraints: cmc-ingredient-functions, cmc-amount-ratio-or-quantity
..... extension 0..*ExtensionExtension
..... modifierExtension ?!Σ0..*ExtensionExtension
..... amount SΣ1..2QuantityThe measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
..... location SΣ0..*CodeableConceptProduct Part Ingredient Physical Location
...... extension 0..*ExtensionAdditional content defined by implementations
...... coding SΣ1..1CodingCode defined by a terminology system
Binding: ?? (required)
...... text SΣ0..1stringPlain text representation of the concept
..... function SΣ1..2CodeableConceptThe function of this constituent within the component e.g. binder
..... hasIngredient S1..1LiteralCodeableReference(Drug Product Component | #sd-pqcmc-component-pqcmc-component) {b}left: Reference to a resource or a concept; right: The ingredient that is the constituent of the given component
.... property SΣ2..*BackboneElementGeneral characteristics of this component
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type SΣ1..1CodeableConceptA code expressing the type of characteristic
Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
...... extension 0..*ExtensionAdditional content defined by implementations
...... coding Σ0..*CodingCode defined by a terminology system
...... text SΣ1..1stringPlain text representation of the concept
..... value[x] Σ0..1A value for the characteristic
...... valueCodeableConceptCodeableConcept
...... valueQuantityQuantity
...... valueDatedate
...... valueBooleanboolean
...... valueMarkdownmarkdown
...... valueAttachmentAttachment
...... valueReferenceReference(Binary)
.... component SΣ0..*A component that this component contains or is made from

doco Documentation for this format