Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot 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:

• Use this Resource Profile: CMC eCTD 32P32 Document
• 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
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
manufacturedDoseForm		1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required)
manufacturer	S	0..*	LiteralReference(Basic Organization) {b}	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.text
property:All Slices				Content/Rules for all slices
type	S	1..1	CodeableConcept	A code expressing the type of characteristic
text	S	1..1	string	Plain text representation of the concept
property:BatchSize	S	1..1	BackboneElement	Batch Quantity
type
text		0..1	string	Plain text representation of the concept Required Pattern: Batch Quantity
value[x]	S	1..1	Quantity	A value for the characteristic Binding: Units Of Measure (required)
value	S	1..1	decimal	Numerical value (with implicit precision)
code		0..1	code	Quantity UOM
property:BatchUtil	S	1..*	BackboneElement	Batch Utilization
type
text		0..1	string	Plain text representation of the concept Required Pattern: Batch Utilization
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Batch utilization Terminology (required)
property:AddInfo	S	0..1	BackboneElement	Batch Formula Additional Information
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x]	S	1..1	markdown	A value for the characteristic
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 Binding: Product Part Type Terminology (required)
Slices for amount		2..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:perBatch	S	1..1	Quantity	Component Quantity Per Batch
value	S	1..1	decimal	Numerical value (with implicit precision)
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	S	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)
value	S	1..1	decimal	Numerical value (with implicit precision)
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit Binding: Percentage Units (required)
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
StrengthTextual	S	0..1	string	Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension
Slices for amount	S	2..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:perBatch	S	1..1	Quantity	Component Quantity Per Batch
value	S	1..1	decimal	Numerical value (with implicit precision)
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	S	1..1	Quantity	Quantity Percent
value	S	1..1	decimal	Numerical value (with implicit precision)
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit Binding: Percentage Units (required)
location	S	0..*	CodeableConcept	Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required)
hasIngredient	S	1..1	LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b}	Reference to a resource or a concept
Slices for property	S	1..*	BackboneElement	General characteristics of this component Slice: Unordered, Closed by value:type.text
property:All Slices				Content/Rules for all slices
type	S	1..1	CodeableConcept	A code expressing the type of characteristic
text	S	1..1	string	Plain text representation of the concept
property:PPiD	S	1..1	BackboneElement	Product Part Identifier
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Identifier
value[x]	S	1..1	CodeableConceptTextOnly	Concept - reference to a terminology or just text
property:PPiDref	S	0..1	BackboneElement	Product Part Identifier Reference
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Identifier Reference
value[x]	S	1..1	CodeableConceptTextOnly	Concept - reference to a terminology or just text
property:AddInfo	S	0..1	BackboneElement	Product Part Additional Information
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x]	S	1..1	markdown	A value for the characteristic
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.manufacturedDoseForm	required	PqcmcManufacturedDoseFormTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology from this IG
ManufacturedItemDefinition.property:BatchSize.value[x]	required	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:BatchUtil.value[x]	required	PqcmcBatchUtilizationTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology from this IG
ManufacturedItemDefinition.component.type	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount:perBatch.code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG
ManufacturedItemDefinition.component.amount:percent.code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.amount:perBatch.code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.amount:percent.code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.location	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG

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
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: Manufactured Dose Form Terminology (required)
manufacturer	SΣ	0..*	LiteralReference(Basic Organization) {b}	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.text
property:All Slices				Content/Rules for all slices
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.
text	SΣ	1..1	string	Plain text representation of the concept
property:BatchSize	SΣ	1..1	BackboneElement	Batch Quantity
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.
text	Σ	0..1	string	Plain text representation of the concept Required Pattern: Batch Quantity
value[x]	SΣ	1..1	Quantity	A value for the characteristic Binding: Units Of Measure (required)
value	SΣ	1..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.
code	ΣC	0..1	code	Quantity UOM
property:BatchUtil	SΣ	1..*	BackboneElement	Batch Utilization
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.
text	Σ	0..1	string	Plain text representation of the concept Required Pattern: Batch Utilization
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Batch utilization Terminology (required)
property:AddInfo	SΣ	0..1	BackboneElement	Batch Formula Additional Information
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.
text	Σ	0..1	string	Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x]	SΣ	1..1	markdown	A value for the characteristic
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 Binding: Product Part Type Terminology (required)
Slices for amount	Σ	2..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:perBatch	SΣ	1..1	Quantity	Component Quantity Per Batch
value	SΣ	1..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	Unit representation
code	SΣC	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	SΣ	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)
value	SΣ	1..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	Unit representation
code	SΣC	1..1	code	Coded form of the unit Binding: Percentage Units (required)
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
StrengthTextual	S	0..1	string	Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for amount	SΣ	2..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:perBatch	SΣ	1..1	Quantity	Component Quantity Per Batch
value	SΣ	1..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	Unit representation
code	SΣC	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	SΣ	1..1	Quantity	Quantity Percent
value	SΣ	1..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	Unit representation
code	SΣC	1..1	code	Coded form of the unit Binding: Percentage Units (required)
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required)
hasIngredient	S	1..1	LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b}	Reference to a resource or a concept
Slices for property	SΣ	1..*	BackboneElement	General characteristics of this component Slice: Unordered, Closed by value:type.text
property:All Slices				Content/Rules for all slices
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.
text	SΣ	1..1	string	Plain text representation of the concept
property:PPiD	SΣ	1..1	BackboneElement	Product Part Identifier
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.
text	Σ	0..1	string	Plain text representation of the concept Required Pattern: Product Part Identifier
value[x]	S	1..1	CodeableConceptTextOnly	Concept - reference to a terminology or just text
property:PPiDref	SΣ	0..1	BackboneElement	Product Part Identifier Reference
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.
text	Σ	0..1	string	Plain text representation of the concept Required Pattern: Product Part Identifier Reference
value[x]	S	1..1	CodeableConceptTextOnly	Concept - reference to a terminology or just text
property:AddInfo	SΣ	0..1	BackboneElement	Product Part Additional Information
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.
text	Σ	0..1	string	Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x]	SΣ	1..1	markdown	A value for the characteristic
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	URI
ManufacturedItemDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	required	PqcmcManufacturedDoseFormTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology from this IG
ManufacturedItemDefinition.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x]	required	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:BatchSize.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.value[x]	required	PqcmcBatchUtilizationTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology from this IG
ManufacturedItemDefinition.property:AddInfo.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.type	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount:perBatch.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:perBatch.code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG
ManufacturedItemDefinition.component.amount:percent.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:percent.code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.amount:perBatch.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:perBatch.code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.amount:percent.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:percent.code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.location	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiD.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiDref.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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
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: Manufactured Dose Form Terminology (required)
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..*	LiteralReference(Basic Organization) {b}	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.text
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	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.
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	Plain text representation of the concept
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueMarkdown			markdown
valueAttachment			Attachment
valueReference			Reference(Binary)
property:BatchSize	SΣ	1..1	BackboneElement	Batch Quantity
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.
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	Σ	0..1	string	Plain text representation of the concept Required Pattern: Batch Quantity
value[x]	SΣ	1..1	Quantity	A value for the characteristic Binding: Units Of Measure (required)
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	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	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Quantity UOM
property:BatchUtil	SΣ	1..*	BackboneElement	Batch Utilization
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.
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	Σ	0..1	string	Plain text representation of the concept Required Pattern: Batch Utilization
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Batch utilization Terminology (required)
property:AddInfo	SΣ	0..1	BackboneElement	Batch Formula Additional Information
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.
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	Σ	0..1	string	Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x]	SΣ	1..1	markdown	A value for the characteristic
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 Binding: Product Part Type Terminology (required)
function	Σ	0..*	CodeableConcept	The function of this component within the item e.g. delivers active ingredient, masks taste
Slices for amount	Σ	2..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:perBatch	SΣ	1..1	Quantity	Component Quantity Per Batch
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	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	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	SΣ	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)
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	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	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Percentage Units (required)
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
StrengthTextual	S	0..1	string	Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for amount	SΣ	2..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:perBatch	SΣ	1..1	Quantity	Component Quantity Per Batch
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	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	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	SΣ	1..1	Quantity	Quantity Percent
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	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	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Percentage Units (required)
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required)
function	Σ	0..*	CodeableConcept	The function of this constituent within the component e.g. binder
hasIngredient	S	1..1	LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b}	Reference to a resource or a concept
Slices for property	SΣ	1..*	BackboneElement	General characteristics of this component Slice: Unordered, Closed by value:type.text
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	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.
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	Plain text representation of the concept
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueMarkdown			markdown
valueAttachment			Attachment
valueReference			Reference(Binary)
property:PPiD	SΣ	1..1	BackboneElement	Product Part Identifier
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.
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	Σ	0..1	string	Plain text representation of the concept Required Pattern: Product Part Identifier
value[x]	S	1..1	CodeableConceptTextOnly	Concept - reference to a terminology or just text
property:PPiDref	SΣ	0..1	BackboneElement	Product Part Identifier Reference
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.
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	Σ	0..1	string	Plain text representation of the concept Required Pattern: Product Part Identifier Reference
value[x]	S	1..1	CodeableConceptTextOnly	Concept - reference to a terminology or just text
property:AddInfo	SΣ	0..1	BackboneElement	Product Part Additional Information
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.
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	Σ	0..1	string	Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x]	SΣ	1..1	markdown	A value for the characteristic
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	URI
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	required	PqcmcManufacturedDoseFormTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology from this IG
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	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x]	required	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:BatchSize.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.value[x]	required	PqcmcBatchUtilizationTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology from this IG
ManufacturedItemDefinition.property:AddInfo.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.type	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount:perBatch.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:perBatch.code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG
ManufacturedItemDefinition.component.amount:percent.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:percent.code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.amount:perBatch.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:perBatch.code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.amount:percent.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:percent.code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.location	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiD.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiDref.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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: 30 elements(3 nested mandatory elements)
Must-Support: 49 elements

Structures

This structure refers to these other structures:

• Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
• Basic Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization)
• Literal Coded Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference)
• Drug Product Batch Formula Ingredient (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient)
• Text Only Codeable Concept (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only)

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
• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-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
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
manufacturedDoseForm		1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required)
manufacturer	S	0..*	LiteralReference(Basic Organization) {b}	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.text
property:All Slices				Content/Rules for all slices
type	S	1..1	CodeableConcept	A code expressing the type of characteristic
text	S	1..1	string	Plain text representation of the concept
property:BatchSize	S	1..1	BackboneElement	Batch Quantity
type
text		0..1	string	Plain text representation of the concept Required Pattern: Batch Quantity
value[x]	S	1..1	Quantity	A value for the characteristic Binding: Units Of Measure (required)
value	S	1..1	decimal	Numerical value (with implicit precision)
code		0..1	code	Quantity UOM
property:BatchUtil	S	1..*	BackboneElement	Batch Utilization
type
text		0..1	string	Plain text representation of the concept Required Pattern: Batch Utilization
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Batch utilization Terminology (required)
property:AddInfo	S	0..1	BackboneElement	Batch Formula Additional Information
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x]	S	1..1	markdown	A value for the characteristic
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 Binding: Product Part Type Terminology (required)
Slices for amount		2..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:perBatch	S	1..1	Quantity	Component Quantity Per Batch
value	S	1..1	decimal	Numerical value (with implicit precision)
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	S	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)
value	S	1..1	decimal	Numerical value (with implicit precision)
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit Binding: Percentage Units (required)
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
StrengthTextual	S	0..1	string	Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension
Slices for amount	S	2..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:perBatch	S	1..1	Quantity	Component Quantity Per Batch
value	S	1..1	decimal	Numerical value (with implicit precision)
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	S	1..1	Quantity	Quantity Percent
value	S	1..1	decimal	Numerical value (with implicit precision)
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit Binding: Percentage Units (required)
location	S	0..*	CodeableConcept	Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required)
hasIngredient	S	1..1	LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b}	Reference to a resource or a concept
Slices for property	S	1..*	BackboneElement	General characteristics of this component Slice: Unordered, Closed by value:type.text
property:All Slices				Content/Rules for all slices
type	S	1..1	CodeableConcept	A code expressing the type of characteristic
text	S	1..1	string	Plain text representation of the concept
property:PPiD	S	1..1	BackboneElement	Product Part Identifier
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Identifier
value[x]	S	1..1	CodeableConceptTextOnly	Concept - reference to a terminology or just text
property:PPiDref	S	0..1	BackboneElement	Product Part Identifier Reference
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Identifier Reference
value[x]	S	1..1	CodeableConceptTextOnly	Concept - reference to a terminology or just text
property:AddInfo	S	0..1	BackboneElement	Product Part Additional Information
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x]	S	1..1	markdown	A value for the characteristic
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.manufacturedDoseForm	required	PqcmcManufacturedDoseFormTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology from this IG
ManufacturedItemDefinition.property:BatchSize.value[x]	required	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:BatchUtil.value[x]	required	PqcmcBatchUtilizationTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology from this IG
ManufacturedItemDefinition.component.type	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount:perBatch.code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG
ManufacturedItemDefinition.component.amount:percent.code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.amount:perBatch.code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.amount:percent.code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.location	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG

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
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: Manufactured Dose Form Terminology (required)
manufacturer	SΣ	0..*	LiteralReference(Basic Organization) {b}	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.text
property:All Slices				Content/Rules for all slices
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.
text	SΣ	1..1	string	Plain text representation of the concept
property:BatchSize	SΣ	1..1	BackboneElement	Batch Quantity
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.
text	Σ	0..1	string	Plain text representation of the concept Required Pattern: Batch Quantity
value[x]	SΣ	1..1	Quantity	A value for the characteristic Binding: Units Of Measure (required)
value	SΣ	1..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.
code	ΣC	0..1	code	Quantity UOM
property:BatchUtil	SΣ	1..*	BackboneElement	Batch Utilization
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.
text	Σ	0..1	string	Plain text representation of the concept Required Pattern: Batch Utilization
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Batch utilization Terminology (required)
property:AddInfo	SΣ	0..1	BackboneElement	Batch Formula Additional Information
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.
text	Σ	0..1	string	Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x]	SΣ	1..1	markdown	A value for the characteristic
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 Binding: Product Part Type Terminology (required)
Slices for amount	Σ	2..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:perBatch	SΣ	1..1	Quantity	Component Quantity Per Batch
value	SΣ	1..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	Unit representation
code	SΣC	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	SΣ	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)
value	SΣ	1..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	Unit representation
code	SΣC	1..1	code	Coded form of the unit Binding: Percentage Units (required)
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
StrengthTextual	S	0..1	string	Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for amount	SΣ	2..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:perBatch	SΣ	1..1	Quantity	Component Quantity Per Batch
value	SΣ	1..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	Unit representation
code	SΣC	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	SΣ	1..1	Quantity	Quantity Percent
value	SΣ	1..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	Unit representation
code	SΣC	1..1	code	Coded form of the unit Binding: Percentage Units (required)
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required)
hasIngredient	S	1..1	LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b}	Reference to a resource or a concept
Slices for property	SΣ	1..*	BackboneElement	General characteristics of this component Slice: Unordered, Closed by value:type.text
property:All Slices				Content/Rules for all slices
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.
text	SΣ	1..1	string	Plain text representation of the concept
property:PPiD	SΣ	1..1	BackboneElement	Product Part Identifier
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.
text	Σ	0..1	string	Plain text representation of the concept Required Pattern: Product Part Identifier
value[x]	S	1..1	CodeableConceptTextOnly	Concept - reference to a terminology or just text
property:PPiDref	SΣ	0..1	BackboneElement	Product Part Identifier Reference
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.
text	Σ	0..1	string	Plain text representation of the concept Required Pattern: Product Part Identifier Reference
value[x]	S	1..1	CodeableConceptTextOnly	Concept - reference to a terminology or just text
property:AddInfo	SΣ	0..1	BackboneElement	Product Part Additional Information
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.
text	Σ	0..1	string	Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x]	SΣ	1..1	markdown	A value for the characteristic
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	URI
ManufacturedItemDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	required	PqcmcManufacturedDoseFormTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology from this IG
ManufacturedItemDefinition.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x]	required	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:BatchSize.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.value[x]	required	PqcmcBatchUtilizationTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology from this IG
ManufacturedItemDefinition.property:AddInfo.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.type	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount:perBatch.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:perBatch.code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG
ManufacturedItemDefinition.component.amount:percent.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:percent.code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.amount:perBatch.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:perBatch.code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.amount:percent.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:percent.code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.location	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiD.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiDref.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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
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: Manufactured Dose Form Terminology (required)
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..*	LiteralReference(Basic Organization) {b}	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.text
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	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.
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	Plain text representation of the concept
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueMarkdown			markdown
valueAttachment			Attachment
valueReference			Reference(Binary)
property:BatchSize	SΣ	1..1	BackboneElement	Batch Quantity
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.
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	Σ	0..1	string	Plain text representation of the concept Required Pattern: Batch Quantity
value[x]	SΣ	1..1	Quantity	A value for the characteristic Binding: Units Of Measure (required)
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	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	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Quantity UOM
property:BatchUtil	SΣ	1..*	BackboneElement	Batch Utilization
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.
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	Σ	0..1	string	Plain text representation of the concept Required Pattern: Batch Utilization
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Batch utilization Terminology (required)
property:AddInfo	SΣ	0..1	BackboneElement	Batch Formula Additional Information
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.
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	Σ	0..1	string	Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x]	SΣ	1..1	markdown	A value for the characteristic
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 Binding: Product Part Type Terminology (required)
function	Σ	0..*	CodeableConcept	The function of this component within the item e.g. delivers active ingredient, masks taste
Slices for amount	Σ	2..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:perBatch	SΣ	1..1	Quantity	Component Quantity Per Batch
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	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	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	SΣ	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)
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	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	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Percentage Units (required)
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
StrengthTextual	S	0..1	string	Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for amount	SΣ	2..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:perBatch	SΣ	1..1	Quantity	Component Quantity Per Batch
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	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	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	SΣ	1..1	Quantity	Quantity Percent
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	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	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Percentage Units (required)
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required)
function	Σ	0..*	CodeableConcept	The function of this constituent within the component e.g. binder
hasIngredient	S	1..1	LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b}	Reference to a resource or a concept
Slices for property	SΣ	1..*	BackboneElement	General characteristics of this component Slice: Unordered, Closed by value:type.text
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	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.
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	Plain text representation of the concept
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueMarkdown			markdown
valueAttachment			Attachment
valueReference			Reference(Binary)
property:PPiD	SΣ	1..1	BackboneElement	Product Part Identifier
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.
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	Σ	0..1	string	Plain text representation of the concept Required Pattern: Product Part Identifier
value[x]	S	1..1	CodeableConceptTextOnly	Concept - reference to a terminology or just text
property:PPiDref	SΣ	0..1	BackboneElement	Product Part Identifier Reference
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.
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	Σ	0..1	string	Plain text representation of the concept Required Pattern: Product Part Identifier Reference
value[x]	S	1..1	CodeableConceptTextOnly	Concept - reference to a terminology or just text
property:AddInfo	SΣ	0..1	BackboneElement	Product Part Additional Information
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.
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	Σ	0..1	string	Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x]	SΣ	1..1	markdown	A value for the characteristic
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	URI
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	required	PqcmcManufacturedDoseFormTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology from this IG
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	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x]	required	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:BatchSize.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.value[x]	required	PqcmcBatchUtilizationTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology from this IG
ManufacturedItemDefinition.property:AddInfo.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.type	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount:perBatch.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:perBatch.code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG
ManufacturedItemDefinition.component.amount:percent.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:percent.code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.amount:perBatch.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:perBatch.code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.amount:percent.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:percent.code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG
ManufacturedItemDefinition.component.constituent.location	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiD.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiDref.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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: 30 elements(3 nested mandatory elements)
Must-Support: 49 elements

Structures

This structure refers to these other structures:

• Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
• Basic Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization)
• Literal Coded Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference)
• Drug Product Batch Formula Ingredient (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient)
• Text Only Codeable Concept (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only)

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
• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-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)