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 1.1.2 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

• Content
• Detailed Descriptions
• XML
• JSON

Resource Profile: Drug Product Batch Formula

Listing of all components of the dosage form to be used in the manufacture, their amounts on a per batch basis, including overages, and reference to their quality standards.

Usage:

• Refer to this Resource Profile: Batch Formula Drug Product Identification

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from ManufacturedItemDefinition

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition			ManufacturedItemDefinition
meta
profile	S	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
identifier	S	0..1	Identifier	optional user designated identifier
status	S	1..1	code	draft | active | retired | unknown
name	S	1..1	string	Product Non-proprietary Name
manufacturer	S	0..*	Reference(Manufacturing and/or Test Site Organization)	Manufacturer of the item, one of several possible
Slices for property	S	2..*	BackboneElement	General characteristics of this item Slice: Unordered, Closed by value:type
property:BatchSize	S	1..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	Batch Quantity Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: batchsize
display		1..1	string	Representation defined by the system Fixed Value: Batch Quantity
value[x]		0..1	Quantity	A value for the characteristic
unit	S	1..1	string	Quantity UOM
code	S	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:BatchUtil	S	1..*	BackboneElement	General characteristics of this item
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: BatchUtil
display		1..1	string	Representation defined by the system Fixed Value: Batch Utilization
value[x]	S	1..1	CodeableConcept	Batch Utilization
coding		0..*	Coding	Code defined by a terminology system Binding: Batch utilization Terminology (required)
property:AddInfo	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
value[x]		0..1	markdown	Product Part Additional Information
component	S	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
type	S	1..1	CodeableConcept	Product Part Type
Slices for amount	S	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) Slice: Unordered, Closed by value:code
amount:Weight	SC	1..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) cmc-percent-quantity: The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
value	S	1..1	decimal	Component Quantity Per Batch
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
amount:VolumeToVolume	S	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Quantity Percent
code		1..1	code	Coded form of the unit Required Pattern: C48571
amount:WeightToVolume	S	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Quantity Percent
code		1..1	code	Coded form of the unit Required Pattern: C48527
amount:WeightToWeight	S	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Quantity Percent
code		1..1	code	Coded form of the unit Required Pattern: C48528
constituent	S	1..*	BackboneElement	A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
additional-info	S	0..1	markdown	Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
formulaIngredient	S	0..1	(Complex)	Product Batch Ingredient Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension
Slices for amount	S	1..2	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code
amount:Weight	SC	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) cmc-percent-quantity: The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
value	S	1..1	decimal	Component Quantity Per Batch
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
amount:VolumeToVolume	S	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Quantity Percent
code		1..1	code	Coded form of the unit Required Pattern: C48571
amount:WeightToVolume	S	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Quantity Percent
code		1..1	code	Coded form of the unit Required Pattern: C48527
amount:WeightToWeight	S	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Quantity Percent
code		1..1	code	Coded form of the unit Required Pattern: C48528
location	S	0..*	CodeableConcept	Product Part Ingredient Physical Location
coding		0..*	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
hasIngredient	S	1..1	CodeableReference(Drug Product Batch Formula Ingredient)	The ingredient that is the constituent of the given component
Slices for property	S	1..3		General characteristics of this component Slice: Unordered, Closed by value:type
property:PPiD	S	1..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiD
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier
value[x]	S	1..1	CodeableConcept	A value for the characteristic
coding		0..*	Coding	Product Part Role Binding: Relationship Types Terminology (required)
text	S	1..1	string	Product Part Identifier
property:PPiDref	S	0..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiDref
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier Reference
value[x]	S	1..1	CodeableConcept	A value for the characteristic
text	S	1..1	string	Product Part Identifier Reference
property:AddInfo	S	0..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
value[x]		0..1	markdown	Product Part Additional Information
component	S	0..*		A component that this component contains or is made from
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
ManufacturedItemDefinition.property:BatchSize.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:BatchUtil.value[x].coding	required	PqcmcBatchUtilizationTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology from this IG
ManufacturedItemDefinition.component.amount:Weight.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.amount:Weight.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.location.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.property:PPiD.value[x].coding	required	CmcRelationshipTypesVS (a valid code from Relationship Types Codes) http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-relationship-types-vs from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-percent-quantity	error	ManufacturedItemDefinition.component.amount:Weight, ManufacturedItemDefinition.component.constituent.amount:Weight	The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight : code in ('C48527'|'C48527'|'C48528').count() = 0

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition		0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
meta	Σ	0..1	Meta	Metadata about the resource
profile	SΣ	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..1	Identifier	optional user designated identifier
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name	SΣ	1..1	string	Product Non-proprietary Name
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: ManufacturedDoseForm (example): Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary.
manufacturer	SΣ	0..*	Reference(Manufacturing and/or Test Site Organization)	Manufacturer of the item, one of several possible
Slices for property	SΣ	2..*	BackboneElement	General characteristics of this item Slice: Unordered, Closed by value:type
property:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
property:BatchSize	SΣ	1..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	Batch Quantity Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: batchsize
display		1..1	string	Representation defined by the system Fixed Value: Batch Quantity
value[x]	Σ	0..1	Quantity	A value for the characteristic
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Quantity UOM
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:BatchUtil	SΣ	1..*	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: BatchUtil
display		1..1	string	Representation defined by the system Fixed Value: Batch Utilization
value[x]	SΣ	1..1	CodeableConcept	Batch Utilization
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Batch utilization Terminology (required)
property:AddInfo	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
value[x]	Σ	0..1	markdown	Product Part Additional Information
component	SΣ	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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	Product Part Type
Slices for amount	SΣ	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) Slice: Unordered, Closed by value:code
amount:Weight	SΣC	1..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) cmc-percent-quantity: The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
value	SΣ	1..1	decimal	Component Quantity Per Batch
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Unit representation
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
amount:VolumeToVolume	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48571
amount:WeightToVolume	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48527
amount:WeightToWeight	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48528
constituent	SΣ	1..*	BackboneElement	A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
additional-info	S	0..1	markdown	Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
formulaIngredient	S	0..1	(Complex)	Product Batch Ingredient Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for amount	SΣ	1..2	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code
amount:Weight	SΣC	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) cmc-percent-quantity: The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
value	SΣ	1..1	decimal	Component Quantity Per Batch
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Unit representation
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
amount:VolumeToVolume	SΣ	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48571
amount:WeightToVolume	SΣ	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48527
amount:WeightToWeight	SΣ	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48528
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
hasIngredient	SΣ	1..1	CodeableReference(Drug Product Batch Formula Ingredient)	The ingredient that is the constituent of the given component
Slices for property	SΣ	1..3	See property (ManufacturedItemDefinition)	General characteristics of this component Slice: Unordered, Closed by value:type
property:PPiD	SΣ	1..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiD
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
coding	Σ	0..*	Coding	Product Part Role Binding: Relationship Types Terminology (required)
text	SΣ	1..1	string	Product Part Identifier
property:PPiDref	SΣ	0..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiDref
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier Reference
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
text	SΣ	1..1	string	Product Part Identifier Reference
property:AddInfo	SΣ	0..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
value[x]	Σ	0..1	markdown	Product Part Additional Information
component	SΣ	0..*	See component (ManufacturedItemDefinition)	A component that this component contains or is made from
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
ManufacturedItemDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	example	ManufacturedDoseForm http://hl7.org/fhir/ValueSet/manufactured-dose-form from the FHIR Standard
ManufacturedItemDefinition.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.type	example	Pattern: batchsize("Batch Quantity") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:BatchUtil.type	example	Pattern: BatchUtil("Batch Utilization") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.value[x].coding	required	PqcmcBatchUtilizationTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology from this IG
ManufacturedItemDefinition.property:AddInfo.type	example	Pattern: AddInfo("Product Part Additional Information") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.amount:Weight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:Weight.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.amount:VolumeToVolume.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:WeightToVolume.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:WeightToWeight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:Weight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:Weight.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.amount:VolumeToVolume.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:WeightToVolume.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:WeightToWeight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.location.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.property:PPiD.type	example	Pattern: PPiD("Product Part Identifier") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiD.value[x].coding	required	CmcRelationshipTypesVS (a valid code from Relationship Types Codes) http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-relationship-types-vs from this IG
ManufacturedItemDefinition.component.property:PPiDref.type	example	Pattern: PPiDref("Product Part Identifier Reference") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.type	example	Pattern: AddInfo("Product Part Additional Information") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-percent-quantity	error	ManufacturedItemDefinition.component.amount:Weight, ManufacturedItemDefinition.component.constituent.amount:Weight	The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight : code in ('C48527'|'C48527'|'C48528').count() = 0
dom-2	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ManufacturedItemDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition		0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Version specific identifier
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	Σ	0..1	uri	Identifies where the resource comes from
profile	SΣ	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
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: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..1	Identifier	optional user designated identifier
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name	SΣ	1..1	string	Product Non-proprietary Name
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: ManufacturedDoseForm (example): Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary.
unitOfPresentation	Σ	0..1	CodeableConcept	The “real-world” units in which the quantity of the item is described Binding: UnitOfPresentation (example): The presentation type in which an administrable medicinal product is given to a patient.
manufacturer	SΣ	0..*	Reference(Manufacturing and/or Test Site 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: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Slices for property	SΣ	2..*	BackboneElement	General characteristics of this item Slice: Unordered, Closed by value:type
property:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
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)
property:BatchSize	SΣ	1..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	Batch Quantity Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: batchsize
display		1..1	string	Representation defined by the system Fixed Value: Batch Quantity
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	Quantity	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	Numerical value (with implicit precision)
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Quantity UOM
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:BatchUtil	SΣ	1..*	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: BatchUtil
display		1..1	string	Representation defined by the system Fixed Value: Batch Utilization
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	Batch Utilization
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Batch utilization Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
property:AddInfo	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	markdown	Product Part Additional Information
component	SΣ	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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	Product Part Type
function	Σ	0..*	CodeableConcept	The function of this component within the item e.g. delivers active ingredient, masks taste
Slices for amount	SΣ	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) Slice: Unordered, Closed by value:code
amount:Weight	SΣC	1..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) cmc-percent-quantity: The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Component Quantity Per Batch
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
amount:VolumeToVolume	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48571
amount:WeightToVolume	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48527
amount:WeightToWeight	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48528
constituent	SΣ	1..*	BackboneElement	A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
additional-info	S	0..1	markdown	Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
formulaIngredient	S	0..1	(Complex)	Product Batch Ingredient Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for amount	SΣ	1..2	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code
amount:Weight	SΣC	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) cmc-percent-quantity: The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Component Quantity Per Batch
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
amount:VolumeToVolume	SΣ	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48571
amount:WeightToVolume	SΣ	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48527
amount:WeightToWeight	SΣ	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48528
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
function	Σ	0..*	CodeableConcept	The function of this constituent within the component e.g. binder
hasIngredient	SΣ	1..1	CodeableReference(Drug Product Batch Formula Ingredient)	The ingredient that is the constituent of the given component
Slices for property	SΣ	1..3	See property (ManufacturedItemDefinition)	General characteristics of this component Slice: Unordered, Closed by value:type
property:PPiD	SΣ	1..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiD
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Product Part Role Binding: Relationship Types Terminology (required)
text	SΣ	1..1	string	Product Part Identifier
property:PPiDref	SΣ	0..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiDref
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier Reference
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	SΣ	1..1	string	Product Part Identifier Reference
property:AddInfo	SΣ	0..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	markdown	Product Part Additional Information
component	SΣ	0..*	See component (ManufacturedItemDefinition)	A component that this component contains or is made from
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
ManufacturedItemDefinition.meta.security	extensible	AllSecurityLabels http://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard
ManufacturedItemDefinition.meta.tag	example	CommonTags http://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard
ManufacturedItemDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	example	ManufacturedDoseForm http://hl7.org/fhir/ValueSet/manufactured-dose-form from the FHIR Standard
ManufacturedItemDefinition.unitOfPresentation	example	UnitOfPresentation http://hl7.org/fhir/ValueSet/unit-of-presentation from the FHIR Standard
ManufacturedItemDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
ManufacturedItemDefinition.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.type	example	Pattern: batchsize("Batch Quantity") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:BatchUtil.type	example	Pattern: BatchUtil("Batch Utilization") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.value[x].coding	required	PqcmcBatchUtilizationTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology from this IG
ManufacturedItemDefinition.property:AddInfo.type	example	Pattern: AddInfo("Product Part Additional Information") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.amount:Weight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:Weight.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.amount:VolumeToVolume.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:WeightToVolume.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:WeightToWeight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:Weight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:Weight.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.amount:VolumeToVolume.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:WeightToVolume.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:WeightToWeight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.location.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.property:PPiD.type	example	Pattern: PPiD("Product Part Identifier") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiD.value[x].coding	required	CmcRelationshipTypesVS (a valid code from Relationship Types Codes) http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-relationship-types-vs from this IG
ManufacturedItemDefinition.component.property:PPiDref.type	example	Pattern: PPiDref("Product Part Identifier Reference") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.type	example	Pattern: AddInfo("Product Part Additional Information") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-percent-quantity	error	ManufacturedItemDefinition.component.amount:Weight, ManufacturedItemDefinition.component.constituent.amount:Weight	The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight : code in ('C48527'|'C48527'|'C48528').count() = 0
dom-2	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ManufacturedItemDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from ManufacturedItemDefinition

Summary

Mandatory: 21 elements(17 nested mandatory elements)
Must-Support: 55 elements

Structures

This structure refers to these other structures:

• Manufacturing and/or Test Site Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization)
• Drug Product Batch Formula Ingredient (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of ManufacturedItemDefinition.property (Closed)
• The element 1 is sliced based on the value of ManufacturedItemDefinition.component.amount (Closed)
• The element 1 is sliced based on the value of ManufacturedItemDefinition.component.constituent.amount (Closed)
• The element 1 is sliced based on the value of ManufacturedItemDefinition.component.property (Closed)

Differential View

This structure is derived from ManufacturedItemDefinition

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition			ManufacturedItemDefinition
meta
profile	S	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
identifier	S	0..1	Identifier	optional user designated identifier
status	S	1..1	code	draft | active | retired | unknown
name	S	1..1	string	Product Non-proprietary Name
manufacturer	S	0..*	Reference(Manufacturing and/or Test Site Organization)	Manufacturer of the item, one of several possible
Slices for property	S	2..*	BackboneElement	General characteristics of this item Slice: Unordered, Closed by value:type
property:BatchSize	S	1..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	Batch Quantity Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: batchsize
display		1..1	string	Representation defined by the system Fixed Value: Batch Quantity
value[x]		0..1	Quantity	A value for the characteristic
unit	S	1..1	string	Quantity UOM
code	S	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:BatchUtil	S	1..*	BackboneElement	General characteristics of this item
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: BatchUtil
display		1..1	string	Representation defined by the system Fixed Value: Batch Utilization
value[x]	S	1..1	CodeableConcept	Batch Utilization
coding		0..*	Coding	Code defined by a terminology system Binding: Batch utilization Terminology (required)
property:AddInfo	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
value[x]		0..1	markdown	Product Part Additional Information
component	S	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
type	S	1..1	CodeableConcept	Product Part Type
Slices for amount	S	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) Slice: Unordered, Closed by value:code
amount:Weight	SC	1..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) cmc-percent-quantity: The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
value	S	1..1	decimal	Component Quantity Per Batch
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
amount:VolumeToVolume	S	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Quantity Percent
code		1..1	code	Coded form of the unit Required Pattern: C48571
amount:WeightToVolume	S	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Quantity Percent
code		1..1	code	Coded form of the unit Required Pattern: C48527
amount:WeightToWeight	S	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Quantity Percent
code		1..1	code	Coded form of the unit Required Pattern: C48528
constituent	S	1..*	BackboneElement	A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
additional-info	S	0..1	markdown	Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
formulaIngredient	S	0..1	(Complex)	Product Batch Ingredient Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension
Slices for amount	S	1..2	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code
amount:Weight	SC	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) cmc-percent-quantity: The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
value	S	1..1	decimal	Component Quantity Per Batch
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
amount:VolumeToVolume	S	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Quantity Percent
code		1..1	code	Coded form of the unit Required Pattern: C48571
amount:WeightToVolume	S	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Quantity Percent
code		1..1	code	Coded form of the unit Required Pattern: C48527
amount:WeightToWeight	S	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Quantity Percent
code		1..1	code	Coded form of the unit Required Pattern: C48528
location	S	0..*	CodeableConcept	Product Part Ingredient Physical Location
coding		0..*	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
hasIngredient	S	1..1	CodeableReference(Drug Product Batch Formula Ingredient)	The ingredient that is the constituent of the given component
Slices for property	S	1..3		General characteristics of this component Slice: Unordered, Closed by value:type
property:PPiD	S	1..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiD
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier
value[x]	S	1..1	CodeableConcept	A value for the characteristic
coding		0..*	Coding	Product Part Role Binding: Relationship Types Terminology (required)
text	S	1..1	string	Product Part Identifier
property:PPiDref	S	0..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiDref
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier Reference
value[x]	S	1..1	CodeableConcept	A value for the characteristic
text	S	1..1	string	Product Part Identifier Reference
property:AddInfo	S	0..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
value[x]		0..1	markdown	Product Part Additional Information
component	S	0..*		A component that this component contains or is made from
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
ManufacturedItemDefinition.property:BatchSize.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:BatchUtil.value[x].coding	required	PqcmcBatchUtilizationTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology from this IG
ManufacturedItemDefinition.component.amount:Weight.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.amount:Weight.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.location.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.property:PPiD.value[x].coding	required	CmcRelationshipTypesVS (a valid code from Relationship Types Codes) http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-relationship-types-vs from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-percent-quantity	error	ManufacturedItemDefinition.component.amount:Weight, ManufacturedItemDefinition.component.constituent.amount:Weight	The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight : code in ('C48527'|'C48527'|'C48528').count() = 0

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition		0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
meta	Σ	0..1	Meta	Metadata about the resource
profile	SΣ	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..1	Identifier	optional user designated identifier
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name	SΣ	1..1	string	Product Non-proprietary Name
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: ManufacturedDoseForm (example): Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary.
manufacturer	SΣ	0..*	Reference(Manufacturing and/or Test Site Organization)	Manufacturer of the item, one of several possible
Slices for property	SΣ	2..*	BackboneElement	General characteristics of this item Slice: Unordered, Closed by value:type
property:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
property:BatchSize	SΣ	1..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	Batch Quantity Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: batchsize
display		1..1	string	Representation defined by the system Fixed Value: Batch Quantity
value[x]	Σ	0..1	Quantity	A value for the characteristic
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Quantity UOM
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:BatchUtil	SΣ	1..*	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: BatchUtil
display		1..1	string	Representation defined by the system Fixed Value: Batch Utilization
value[x]	SΣ	1..1	CodeableConcept	Batch Utilization
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Batch utilization Terminology (required)
property:AddInfo	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
value[x]	Σ	0..1	markdown	Product Part Additional Information
component	SΣ	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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	Product Part Type
Slices for amount	SΣ	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) Slice: Unordered, Closed by value:code
amount:Weight	SΣC	1..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) cmc-percent-quantity: The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
value	SΣ	1..1	decimal	Component Quantity Per Batch
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Unit representation
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
amount:VolumeToVolume	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48571
amount:WeightToVolume	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48527
amount:WeightToWeight	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48528
constituent	SΣ	1..*	BackboneElement	A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
additional-info	S	0..1	markdown	Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
formulaIngredient	S	0..1	(Complex)	Product Batch Ingredient Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for amount	SΣ	1..2	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code
amount:Weight	SΣC	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) cmc-percent-quantity: The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
value	SΣ	1..1	decimal	Component Quantity Per Batch
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Unit representation
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
amount:VolumeToVolume	SΣ	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48571
amount:WeightToVolume	SΣ	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48527
amount:WeightToWeight	SΣ	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48528
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
hasIngredient	SΣ	1..1	CodeableReference(Drug Product Batch Formula Ingredient)	The ingredient that is the constituent of the given component
Slices for property	SΣ	1..3	See property (ManufacturedItemDefinition)	General characteristics of this component Slice: Unordered, Closed by value:type
property:PPiD	SΣ	1..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiD
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
coding	Σ	0..*	Coding	Product Part Role Binding: Relationship Types Terminology (required)
text	SΣ	1..1	string	Product Part Identifier
property:PPiDref	SΣ	0..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiDref
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier Reference
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
text	SΣ	1..1	string	Product Part Identifier Reference
property:AddInfo	SΣ	0..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
value[x]	Σ	0..1	markdown	Product Part Additional Information
component	SΣ	0..*	See component (ManufacturedItemDefinition)	A component that this component contains or is made from
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
ManufacturedItemDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	example	ManufacturedDoseForm http://hl7.org/fhir/ValueSet/manufactured-dose-form from the FHIR Standard
ManufacturedItemDefinition.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.type	example	Pattern: batchsize("Batch Quantity") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:BatchUtil.type	example	Pattern: BatchUtil("Batch Utilization") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.value[x].coding	required	PqcmcBatchUtilizationTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology from this IG
ManufacturedItemDefinition.property:AddInfo.type	example	Pattern: AddInfo("Product Part Additional Information") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.amount:Weight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:Weight.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.amount:VolumeToVolume.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:WeightToVolume.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:WeightToWeight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:Weight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:Weight.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.amount:VolumeToVolume.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:WeightToVolume.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:WeightToWeight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.location.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.property:PPiD.type	example	Pattern: PPiD("Product Part Identifier") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiD.value[x].coding	required	CmcRelationshipTypesVS (a valid code from Relationship Types Codes) http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-relationship-types-vs from this IG
ManufacturedItemDefinition.component.property:PPiDref.type	example	Pattern: PPiDref("Product Part Identifier Reference") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.type	example	Pattern: AddInfo("Product Part Additional Information") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-percent-quantity	error	ManufacturedItemDefinition.component.amount:Weight, ManufacturedItemDefinition.component.constituent.amount:Weight	The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight : code in ('C48527'|'C48527'|'C48528').count() = 0
dom-2	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ManufacturedItemDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition		0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Version specific identifier
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	Σ	0..1	uri	Identifies where the resource comes from
profile	SΣ	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
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: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..1	Identifier	optional user designated identifier
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name	SΣ	1..1	string	Product Non-proprietary Name
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: ManufacturedDoseForm (example): Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary.
unitOfPresentation	Σ	0..1	CodeableConcept	The “real-world” units in which the quantity of the item is described Binding: UnitOfPresentation (example): The presentation type in which an administrable medicinal product is given to a patient.
manufacturer	SΣ	0..*	Reference(Manufacturing and/or Test Site 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: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Slices for property	SΣ	2..*	BackboneElement	General characteristics of this item Slice: Unordered, Closed by value:type
property:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
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)
property:BatchSize	SΣ	1..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	Batch Quantity Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: batchsize
display		1..1	string	Representation defined by the system Fixed Value: Batch Quantity
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	Quantity	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	Numerical value (with implicit precision)
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Quantity UOM
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:BatchUtil	SΣ	1..*	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: BatchUtil
display		1..1	string	Representation defined by the system Fixed Value: Batch Utilization
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	Batch Utilization
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Batch utilization Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
property:AddInfo	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	markdown	Product Part Additional Information
component	SΣ	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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	Product Part Type
function	Σ	0..*	CodeableConcept	The function of this component within the item e.g. delivers active ingredient, masks taste
Slices for amount	SΣ	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) Slice: Unordered, Closed by value:code
amount:Weight	SΣC	1..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) cmc-percent-quantity: The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Component Quantity Per Batch
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
amount:VolumeToVolume	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48571
amount:WeightToVolume	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48527
amount:WeightToWeight	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48528
constituent	SΣ	1..*	BackboneElement	A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
additional-info	S	0..1	markdown	Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
formulaIngredient	S	0..1	(Complex)	Product Batch Ingredient Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for amount	SΣ	1..2	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code
amount:Weight	SΣC	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) cmc-percent-quantity: The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Component Quantity Per Batch
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
amount:VolumeToVolume	SΣ	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48571
amount:WeightToVolume	SΣ	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48527
amount:WeightToWeight	SΣ	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	1..1	code	Coded form of the unit Required Pattern: C48528
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
function	Σ	0..*	CodeableConcept	The function of this constituent within the component e.g. binder
hasIngredient	SΣ	1..1	CodeableReference(Drug Product Batch Formula Ingredient)	The ingredient that is the constituent of the given component
Slices for property	SΣ	1..3	See property (ManufacturedItemDefinition)	General characteristics of this component Slice: Unordered, Closed by value:type
property:PPiD	SΣ	1..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiD
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Product Part Role Binding: Relationship Types Terminology (required)
text	SΣ	1..1	string	Product Part Identifier
property:PPiDref	SΣ	0..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiDref
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier Reference
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	SΣ	1..1	string	Product Part Identifier Reference
property:AddInfo	SΣ	0..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	markdown	Product Part Additional Information
component	SΣ	0..*	See component (ManufacturedItemDefinition)	A component that this component contains or is made from
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
ManufacturedItemDefinition.meta.security	extensible	AllSecurityLabels http://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard
ManufacturedItemDefinition.meta.tag	example	CommonTags http://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard
ManufacturedItemDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	example	ManufacturedDoseForm http://hl7.org/fhir/ValueSet/manufactured-dose-form from the FHIR Standard
ManufacturedItemDefinition.unitOfPresentation	example	UnitOfPresentation http://hl7.org/fhir/ValueSet/unit-of-presentation from the FHIR Standard
ManufacturedItemDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
ManufacturedItemDefinition.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.type	example	Pattern: batchsize("Batch Quantity") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:BatchUtil.type	example	Pattern: BatchUtil("Batch Utilization") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.value[x].coding	required	PqcmcBatchUtilizationTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology from this IG
ManufacturedItemDefinition.property:AddInfo.type	example	Pattern: AddInfo("Product Part Additional Information") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.amount:Weight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:Weight.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.amount:VolumeToVolume.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:WeightToVolume.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:WeightToWeight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:Weight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:Weight.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.amount:VolumeToVolume.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:WeightToVolume.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:WeightToWeight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.location.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.property:PPiD.type	example	Pattern: PPiD("Product Part Identifier") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiD.value[x].coding	required	CmcRelationshipTypesVS (a valid code from Relationship Types Codes) http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-relationship-types-vs from this IG
ManufacturedItemDefinition.component.property:PPiDref.type	example	Pattern: PPiDref("Product Part Identifier Reference") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.type	example	Pattern: AddInfo("Product Part Additional Information") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-percent-quantity	error	ManufacturedItemDefinition.component.amount:Weight, ManufacturedItemDefinition.component.constituent.amount:Weight	The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight : code in ('C48527'|'C48527'|'C48528').count() = 0
dom-2	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ManufacturedItemDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from ManufacturedItemDefinition

Summary

Mandatory: 21 elements(17 nested mandatory elements)
Must-Support: 55 elements

Structures

This structure refers to these other structures:

• Manufacturing and/or Test Site Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization)
• Drug Product Batch Formula Ingredient (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of ManufacturedItemDefinition.property (Closed)
• The element 1 is sliced based on the value of ManufacturedItemDefinition.component.amount (Closed)
• The element 1 is sliced based on the value of ManufacturedItemDefinition.component.constituent.amount (Closed)
• The element 1 is sliced based on the value of ManufacturedItemDefinition.component.property (Closed)