## Intersection 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 both 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).

### Structure

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
ManufacturedItemDefinition | C | 0..* |  | 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 | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 0..1 | Identifier | Unique identifier
status | ?!S Σ | 1..1 | code | draft | active | retired | unknown Binding: ?? (required): The lifecycle status of an artifact.
name | S Σ | 0..1 | string | Product Proprietary Name | Product Non-proprietary Name
manufacturedDoseForm | Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: ?? (required)
unitOfPresentation | Σ | 0..1 | CodeableConcept | The “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 | Σ | 0..* | Reference(Organization) | Manufacturer of the item, one of several possible
marketingStatus | Σ | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
ingredient | Σ | 0..* | CodeableConcept | The 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 | S Σ | 6..* | BackboneElement | General characteristics of this item
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A 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..* | Extension | Additional content defined by implementations
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept
value[x] | Σ | 0..1 |  | A value for the characteristic
valueCodeableConcept |  |  | CodeableConcept |
valueQuantity |  |  | Quantity |
valueDate |  |  | date |
valueBoolean |  |  | boolean |
valueMarkdown |  |  | markdown |
valueAttachment |  |  | Attachment |
valueReference |  |  | Reference(Binary) |
component | S Σ C | 1..* | BackboneElement | Physical 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..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extension
type | S Σ | 1..1 | CodeableConcept | Product Part Type
extension |  | 0..* | Extension | Additional content defined by implementations
coding | Σ | 0..* | Coding | Code defined by a terminology system Binding: ?? (required)
text | Σ | 0..1 | string | Plain text representation of the concept
function | S | 0..* | ??, ?? | Product Part Function Description
amount | S Σ | 1..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
constituent | S Σ C | 1..* | BackboneElement | Product Part Ingredient Component Function Category Constraints: cmc-ingredient-functions, cmc-amount-ratio-or-quantity
extension |  | 0..* | Extension | Extension
modifierExtension | ?!Σ | 0..* | Extension | Extension
amount | S Σ | 1..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
location | S Σ | 0..* | CodeableConcept | Product Part Ingredient Physical Location
extension |  | 0..* | Extension | Additional content defined by implementations
coding | S Σ | 1..1 | Coding | Code defined by a terminology system Binding: ?? (required)
text | S Σ | 0..1 | string | Plain text representation of the concept
function | S Σ | 1..2 | CodeableConcept | The function of this constituent within the component e.g. binder
hasIngredient | S | 1..1 | LiteralCodeableReference(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 | S Σ | 2..* | BackboneElement | General characteristics of this component
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A 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..* | Extension | Additional content defined by implementations
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept
value[x] | Σ | 0..1 |  | A value for the characteristic
valueCodeableConcept |  |  | CodeableConcept |
valueQuantity |  |  | Quantity |
valueDate |  |  | date |
valueBoolean |  |  | boolean |
valueMarkdown |  |  | markdown |
valueAttachment |  |  | Attachment |
valueReference |  |  | Reference(Binary) |
component | S Σ | 0..* |  | A component that this component contains or is made from
Documentation for this format