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: Manufactured Drug Product

The manufactured drug product defined by all its parts or layers. If the drug product composition is homogeneous it will have a single part or component.

Usage:

• Use this Resource Profile: CMC eCTD 32P10 Document
• Refer to this Resource Profile: eCTD Product Description and Composition

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	C	0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory cmc-component-id-ref: If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself
identifier	S	0..1	Identifier	Unique identifier
status	S	1..1	code	draft | active | retired | unknown
name	S	0..1	string	Product Proprietary Name | Product Non-proprietary Name
manufacturedDoseForm		1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required)
Slices for property	S	6..*	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:OvrRelsProf	S	1..1	BackboneElement	Product Overall Release Profile
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Overall Release Profile
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Release Profile Terminology (required)
property:OvrRelsMech	S	0..1	BackboneElement	Product Overall Release Mechanism
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Overall Release Mechanism
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatInd	S	0..1	BackboneElement	Product Coating Indicator
type
text		0..1	string	Plain text representation of the concept Required Pattern: Coating Indicator
value[x]	S	1..1	boolean	A value for the characteristic
property:LayCnt	S	0..1	BackboneElement	Product Tablet Layer Count
type
text		0..1	string	Plain text representation of the concept Required Pattern: Tablet Layer Count
value[x]	S	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
value	S	1..1	decimal	Numerical value (with implicit precision)
property:BeaTypCnt	S	0..1	BackboneElement	Tablet Bead Type Count
type
text		0..1	string	Plain text representation of the concept Required Pattern: Tablet Bead Type Count
value[x]	S	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
value	S	1..1	decimal	Numerical value (with implicit precision)
property:CapClass	S	0..1	BackboneElement	Capsule Shell Part Classification Category
type
text		0..1	string	Plain text representation of the concept Required Pattern: Capsule Classification Category
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Capsule Shell Classification Terminology (required)
property:CapConCnt	S	0..1	BackboneElement	Product Capsule Constituent Count
type
text		0..1	string	Plain text representation of the concept Required Pattern: Capsule Constituent Count
value[x]	S	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
value	S	1..1	decimal	Numerical value (with implicit precision)
property:Schematic	S	1..*	BackboneElement	Product Schematic
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Schematic
value[x]	S	1..1	GraphicAttachment, PDFAttachment	Content in a format defined elsewhere
property:WgtTyp	S	1..1	BackboneElement	Product Weight Type
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Weight Type
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Strength Type Terminology (required)
property:TotWgtNum	S	1..1	BackboneElement	Product Total Weight Numeric Numerator
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Total Weight Numeric Numerator
value[x]	S	1..1	Quantity	A value for the characteristic Binding: Units Of Measure (extensible)
comparator	S	0..1	code	Product Total Weight Operator
property:TotWgtDen	S	0..1	BackboneElement	Product Total Weight Numeric Denominator
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Total Weight Numeric Denominator
value[x]	S	1..1	SimpleQuantity	A fixed quantity (no comparator) Binding: Units Of Measure (extensible)
value	S	1..1	decimal	Numerical value (with implicit precision)
property:TotWgtTxt	S	0..1	BackboneElement	Product Total Weight Textual
type
text		0..1	string	Plain text representation of the concept Required Pattern: Total Weight Textual
value[x]	S	1..1	markdown	A value for the characteristic
property:QualStd	S	1..*	BackboneElement	Product Quality Standard
type
text		0..1	string	Plain text representation of the concept Required Pattern: Quality Standard
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Quality Benchmark Terminology (required)
property:Sterile	S	1..1	BackboneElement	Sterile Product Indicator
type
text		0..1	string	Plain text representation of the concept Required Pattern: Sterile Product Indicator
value[x]	S	1..1	boolean	A value for the characteristic
component	SC	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 cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive
Slices for modifierExtension		0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio	S	0..1	AmountRatio	Amount Ratio
type	S	1..1	CodeableConcept	Product Part Type
coding		0..*	Coding	Code defined by a terminology system Binding: Product Part Type Terminology (required)
function	S	0..*	CodeableConceptTextOnly	Product Part Function Description
Slices for amount	S	0..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, Open by value:code
amount:weight	S	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Product Part Total Weight Numeric
unit	S	1..1	string	Product Part Total Weight Numeric UOM
code		0..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	S	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Product Part Content Percent
unit	S	1..1	string	Product Part Content Percent UOM
code		0..1	code	Coded form of the unit Binding: Percentage Units (required)
constituent	SC	1..*	BackboneElement	Product Part Ingredient Component Function Category cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
textualStrength	S	0..1	(Complex)	Original Text that represents the data as seen/selected/uttered originally URL: http://hl7.org/fhir/StructureDefinition/originalText
value[x]		1..1	string	Textual Strength
Slices for modifierExtension		0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio	S	0..1	AmountRatio	Amount Ratio
Slices for amount	S	1..2	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight	S	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Product Part Ingredient Amount Numeric
unit	S	1..1	string	Product Part Ingredient Amount Numeric UOM
code	S	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	S	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Product Part Ingredient Content Percent
unit	S	1..1	string	Product Part Ingredient Content Percent UOM
code		0..1	code	Coded form of the unit Binding: Percentage Units (required)
location	S	0..*	CodeableConcept	Product Part Ingredient Physical Location
coding	S	1..1	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text	S	0..1	string	Plain text representation of the concept
Slices for function	S	1..2	CodeableConcept	The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:$this
function:Category	S	1..1	CodeableConcept	The function of this constituent within the component e.g. binder Binding: Drug Product Component Function Category Terminology (required)
function:Function	S	0..1	CodeableConcept	Product Part Ingredient Function Binding: Excipient Function Terminology (required)
hasIngredient	S	1..1	LiteralCodeableReference(Drug Product Component) {b}	Reference to a resource or a concept
Slices for property	S	2..*	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:RelsProf	S	1..1	BackboneElement	Product Part Release Profile
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Release Profile
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Release Profile Terminology (required)
property:RelsMech	S	0..1	BackboneElement	Product Part Release Mechanism
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Release Mechanism
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatPurpose	S	0..*	BackboneElement	Coating Product Part Purpose
type
text		0..1	string	Plain text representation of the concept Required Pattern: Coating Product Part Purpose
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Coating Purpose Terminology (required)
property:Color	S	0..1	BackboneElement	Product Part Color Description
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Color Description
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:OvrRelsProf.value[x]	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.property:OvrRelsMech.value[x]	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.property:CapClass.value[x]	required	PqcmcCapsuleClassificationCategory http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category from this IG
ManufacturedItemDefinition.property:WgtTyp.value[x]	required	PqcmcStrengthTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology from this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x]	extensible	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:TotWgtDen.value[x]	extensible	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:QualStd.value[x]	required	PqcmcQualityBenchmarkTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology from this IG
ManufacturedItemDefinition.component.type.coding	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount:weight.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:weight.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.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.constituent.function:Category	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
ManufacturedItemDefinition.component.constituent.function:Function	required	PqcmcExcipientFunctionTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology from this IG
ManufacturedItemDefinition.component.property:RelsProf.value[x]	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.component.property:RelsMech.value[x]	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.component.property:CoatPurpose.value[x]	required	PqcmcCoatingPurpose http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-amount-ratio-or-quantity	error	ManufacturedItemDefinition.component, ManufacturedItemDefinition.component.constituent	The amount ratio extension and an amount with a non-percentage unit are mutually exclusive : defineVariable('system','http://unitsofmeasure.org').select( modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio') .union( amount.where( system = %system and code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units') ) ).count() = 1 )
cmc-arbitrary-unit-text-required	error	ManufacturedItemDefinition	BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( property.where( type.coding.exists( system = %system and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = %system and code = 'C75765') ).exists() implies property.where( type = 'Total Weight Textual' ).exists())
cmc-capsule-classification-required	error	ManufacturedItemDefinition	when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154433' ) and component.type.coding.exists( system = %system and code = 'C203897' ) implies property.where( type.text = 'Capsule Classification Category' ).exists())
cmc-capsule-count-required	error	ManufacturedItemDefinition	Capsule constituent count is required when the dosage form is 'Capsule' : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and code = 'C154433') implies property.where(type.text = 'Capsule Constituent Count').exists())
cmc-coating-indication-required	error	ManufacturedItemDefinition	Coating indication is required when the dosage form is a tablet, lozenge or capsule : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.text = 'Coating Indicator').exists())
cmc-component-id-ref	error	ManufacturedItemDefinition	If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( component.select( property.where( type.text = 'Product Part Identifier Reference' ).select(value) ).all( text in %context.component.select( property.where( type.text = 'Product Part Identifier' ).select(value.text) ) ) and component.where( property.where( type.text = 'Product Part Identifier Reference' ).select(value.text) = property.where( type.text = 'Product Part Identifier' ).select(value.text) ).exists().not() )
cmc-ingredient-functions	error	ManufacturedItemDefinition.component.constituent	If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists() implies function.coding.code.count() = 2
cmc-tablet-bead-count-required	error	ManufacturedItemDefinition	Tablet bead count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Bead Type Count' ).exists())
cmc-tablet-layer-count-required	error	ManufacturedItemDefinition	Tablet layer count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Layer Count' ).exists())

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition	C	0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory cmc-component-id-ref: If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself
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	Unique identifier
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name	SΣ	0..1	string	Product Proprietary Name | Product Non-proprietary Name
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required)
Slices for property	SΣ	6..*	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:OvrRelsProf	SΣ	1..1	BackboneElement	Product Overall Release Profile
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 Overall Release Profile
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Release Profile Terminology (required)
property:OvrRelsMech	SΣ	0..1	BackboneElement	Product Overall Release Mechanism
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 Overall Release Mechanism
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatInd	SΣ	0..1	BackboneElement	Product Coating Indicator
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: Coating Indicator
value[x]	SΣ	1..1	boolean	A value for the characteristic
property:LayCnt	SΣ	0..1	BackboneElement	Product Tablet Layer Count
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: Tablet Layer Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
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.
property:BeaTypCnt	SΣ	0..1	BackboneElement	Tablet Bead Type Count
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: Tablet Bead Type Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
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.
property:CapClass	SΣ	0..1	BackboneElement	Capsule Shell Part Classification Category
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: Capsule Classification Category
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Capsule Shell Classification Terminology (required)
property:CapConCnt	SΣ	0..1	BackboneElement	Product Capsule Constituent Count
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: Capsule Constituent Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
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.
property:Schematic	SΣ	1..*	BackboneElement	Product Schematic
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 Schematic
value[x]	SC	1..1	GraphicAttachment, PDFAttachment	Content in a format defined elsewhere att-1: If the Attachment has data, it SHALL have a contentType
property:WgtTyp	SΣ	1..1	BackboneElement	Product Weight Type
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 Weight Type
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Strength Type Terminology (required)
property:TotWgtNum	SΣ	1..1	BackboneElement	Product Total Weight Numeric Numerator
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 Total Weight Numeric Numerator
value[x]	SΣ	1..1	Quantity	A value for the characteristic Binding: Units Of Measure (extensible)
comparator	?!SΣ	0..1	code	Product Total Weight Operator Binding: QuantityComparator (required): How the Quantity should be understood and represented.
property:TotWgtDen	SΣ	0..1	BackboneElement	Product Total Weight Numeric Denominator
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 Total Weight Numeric Denominator
value[x]	SC	1..1	SimpleQuantity	A fixed quantity (no comparator) Binding: Units Of Measure (extensible) qty-3: If a code for the unit is present, the system SHALL also be present sqty-1: The comparator is not used on a SimpleQuantity
value	SΣ	1..1	decimal	Numerical value (with implicit precision)
property:TotWgtTxt	SΣ	0..1	BackboneElement	Product Total Weight Textual
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: Total Weight Textual
value[x]	SΣ	1..1	markdown	A value for the characteristic
property:QualStd	SΣ	1..*	BackboneElement	Product Quality Standard
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: Quality Standard
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Quality Benchmark Terminology (required)
property:Sterile	SΣ	1..1	BackboneElement	Sterile Product Indicator
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: Sterile Product Indicator
value[x]	SΣ	1..1	boolean	A value for the characteristic
component	SΣC	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 cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive
Slices for modifierExtension	?!Σ	0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio	?!S	0..1	AmountRatio	Amount Ratio
type	SΣ	1..1	CodeableConcept	Product Part Type
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Product Part Type Terminology (required)
function	S	0..*	CodeableConceptTextOnly	Product Part Function Description
Slices for amount	SΣ	0..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, Open by value:code
amount:weight	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Product Part Total Weight Numeric
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	Product Part Total Weight Numeric UOM
code	ΣC	0..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Product Part Content Percent
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	Product Part Content Percent UOM
code	ΣC	0..1	code	Coded form of the unit Binding: Percentage Units (required)
constituent	SΣC	1..*	BackboneElement	Product Part Ingredient Component Function Category cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
textualStrength	S	0..1	(Complex)	Original Text that represents the data as seen/selected/uttered originally URL: http://hl7.org/fhir/StructureDefinition/originalText
extension		0..0
url		1..1	uri	"http://hl7.org/fhir/StructureDefinition/originalText"
value[x]		1..1	string	Textual Strength
Slices for modifierExtension	?!Σ	0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio	?!S	0..1	AmountRatio	Amount Ratio
Slices for amount	SΣ	1..2	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight	SΣ	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Product Part Ingredient Amount Numeric
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	Product Part Ingredient Amount Numeric UOM
code	SΣC	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	SΣ	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Product Part Ingredient Content Percent
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	Product Part Ingredient Content Percent UOM
code	ΣC	0..1	code	Coded form of the unit Binding: Percentage Units (required)
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location
coding	SΣ	1..1	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text	SΣ	0..1	string	Plain text representation of the concept
Slices for function	SΣ	1..2	CodeableConcept	The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:$this
function:Category	SΣ	1..1	CodeableConcept	The function of this constituent within the component e.g. binder Binding: Drug Product Component Function Category Terminology (required)
function:Function	SΣ	0..1	CodeableConcept	Product Part Ingredient Function Binding: Excipient Function Terminology (required)
hasIngredient	S	1..1	LiteralCodeableReference(Drug Product Component) {b}	Reference to a resource or a concept
Slices for property	SΣ	2..*	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:RelsProf	SΣ	1..1	BackboneElement	Product Part Release Profile
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 Release Profile
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Release Profile Terminology (required)
property:RelsMech	SΣ	0..1	BackboneElement	Product Part Release Mechanism
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 Release Mechanism
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatPurpose	SΣ	0..*	BackboneElement	Coating Product Part Purpose
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: Coating Product Part Purpose
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Coating Purpose Terminology (required)
property:Color	SΣ	0..1	BackboneElement	Product Part Color Description
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 Color Description
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:OvrRelsProf.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsProf.value[x]	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.property:OvrRelsMech.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsMech.value[x]	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.property:CoatInd.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:LayCnt.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:LayCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:CapClass.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:CapClass.value[x]	required	PqcmcCapsuleClassificationCategory http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category from this IG
ManufacturedItemDefinition.property:CapConCnt.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:CapConCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:Schematic.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:WgtTyp.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:WgtTyp.value[x]	required	PqcmcStrengthTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology from this IG
ManufacturedItemDefinition.property:TotWgtNum.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtNum.value[x]	extensible	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.value[x]	extensible	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:TotWgtTxt.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:QualStd.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:QualStd.value[x]	required	PqcmcQualityBenchmarkTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology from this IG
ManufacturedItemDefinition.property:Sterile.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.type.coding	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount:weight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:weight.code	required	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:weight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:weight.code	required	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.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.constituent.function:Category	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
ManufacturedItemDefinition.component.constituent.function:Function	required	PqcmcExcipientFunctionTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology 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:RelsProf.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.value[x]	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.component.property:RelsMech.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsMech.value[x]	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.component.property:CoatPurpose.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:CoatPurpose.value[x]	required	PqcmcCoatingPurpose http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose from this IG
ManufacturedItemDefinition.component.property:Color.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
att-1	error	ManufacturedItemDefinition.property:Schematic.value[x]	If the Attachment has data, it SHALL have a contentType : data.empty() or contentType.exists()
cmc-amount-ratio-or-quantity	error	ManufacturedItemDefinition.component, ManufacturedItemDefinition.component.constituent	The amount ratio extension and an amount with a non-percentage unit are mutually exclusive : defineVariable('system','http://unitsofmeasure.org').select( modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio') .union( amount.where( system = %system and code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units') ) ).count() = 1 )
cmc-arbitrary-unit-text-required	error	ManufacturedItemDefinition	BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( property.where( type.coding.exists( system = %system and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = %system and code = 'C75765') ).exists() implies property.where( type = 'Total Weight Textual' ).exists())
cmc-capsule-classification-required	error	ManufacturedItemDefinition	when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154433' ) and component.type.coding.exists( system = %system and code = 'C203897' ) implies property.where( type.text = 'Capsule Classification Category' ).exists())
cmc-capsule-count-required	error	ManufacturedItemDefinition	Capsule constituent count is required when the dosage form is 'Capsule' : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and code = 'C154433') implies property.where(type.text = 'Capsule Constituent Count').exists())
cmc-coating-indication-required	error	ManufacturedItemDefinition	Coating indication is required when the dosage form is a tablet, lozenge or capsule : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.text = 'Coating Indicator').exists())
cmc-component-id-ref	error	ManufacturedItemDefinition	If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( component.select( property.where( type.text = 'Product Part Identifier Reference' ).select(value) ).all( text in %context.component.select( property.where( type.text = 'Product Part Identifier' ).select(value.text) ) ) and component.where( property.where( type.text = 'Product Part Identifier Reference' ).select(value.text) = property.where( type.text = 'Product Part Identifier' ).select(value.text) ).exists().not() )
cmc-ingredient-functions	error	ManufacturedItemDefinition.component.constituent	If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists() implies function.coding.code.count() = 2
cmc-tablet-bead-count-required	error	ManufacturedItemDefinition	Tablet bead count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Bead Type Count' ).exists())
cmc-tablet-layer-count-required	error	ManufacturedItemDefinition	Tablet layer count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Layer Count' ).exists())
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()
qty-3	error	ManufacturedItemDefinition.property:TotWgtDen.value[x]	If a code for the unit is present, the system SHALL also be present : code.empty() or system.exists()
sqty-1	error	ManufacturedItemDefinition.property:TotWgtDen.value[x]	The comparator is not used on a SimpleQuantity : comparator.empty()

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition	C	0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory cmc-component-id-ref: If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself
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	Unique identifier
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name	SΣ	0..1	string	Product Proprietary Name | 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	Σ	0..*	Reference(Organization)	Manufacturer of the item, one of several possible
marketingStatus	Σ	0..*	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
ingredient	Σ	0..*	CodeableConcept	The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Slices for property	SΣ	6..*	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:OvrRelsProf	SΣ	1..1	BackboneElement	Product Overall Release Profile
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 Overall Release Profile
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Release Profile Terminology (required)
property:OvrRelsMech	SΣ	0..1	BackboneElement	Product Overall Release Mechanism
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 Overall Release Mechanism
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatInd	SΣ	0..1	BackboneElement	Product Coating Indicator
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: Coating Indicator
value[x]	SΣ	1..1	boolean	A value for the characteristic
property:LayCnt	SΣ	0..1	BackboneElement	Product Tablet Layer Count
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: Tablet Layer Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
value		0..1	decimal	Numerical value (with implicit precision)
comparator		0..1	code	< | <= | >= | > | ad - how to understand the value
unit		0..1	string	Unit representation
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
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	Coded form of the unit
property:BeaTypCnt	SΣ	0..1	BackboneElement	Tablet Bead Type Count
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: Tablet Bead Type Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
value		0..1	decimal	Numerical value (with implicit precision)
comparator		0..1	code	< | <= | >= | > | ad - how to understand the value
unit		0..1	string	Unit representation
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
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	Coded form of the unit
property:CapClass	SΣ	0..1	BackboneElement	Capsule Shell Part Classification Category
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: Capsule Classification Category
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Capsule Shell Classification Terminology (required)
property:CapConCnt	SΣ	0..1	BackboneElement	Product Capsule Constituent Count
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: Capsule Constituent Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
value		0..1	decimal	Numerical value (with implicit precision)
comparator		0..1	code	< | <= | >= | > | ad - how to understand the value
unit		0..1	string	Unit representation
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
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	Coded form of the unit
property:Schematic	SΣ	1..*	BackboneElement	Product Schematic
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 Schematic
value[x]	SC	1..1	GraphicAttachment, PDFAttachment	Content in a format defined elsewhere att-1: If the Attachment has data, it SHALL have a contentType
property:WgtTyp	SΣ	1..1	BackboneElement	Product Weight Type
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 Weight Type
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Strength Type Terminology (required)
property:TotWgtNum	SΣ	1..1	BackboneElement	Product Total Weight Numeric Numerator
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 Total Weight Numeric Numerator
value[x]	SΣ	1..1	Quantity	A value for the characteristic Binding: Units Of Measure (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	Numerical value (with implicit precision)
comparator	?!SΣ	0..1	code	Product Total Weight Operator 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	Coded form of the unit
property:TotWgtDen	SΣ	0..1	BackboneElement	Product Total Weight Numeric Denominator
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 Total Weight Numeric Denominator
value[x]	SC	1..1	SimpleQuantity	A fixed quantity (no comparator) Binding: Units Of Measure (extensible) qty-3: If a code for the unit is present, the system SHALL also be present sqty-1: The comparator is not used on a SimpleQuantity
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)
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit
property:TotWgtTxt	SΣ	0..1	BackboneElement	Product Total Weight Textual
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: Total Weight Textual
value[x]	SΣ	1..1	markdown	A value for the characteristic
property:QualStd	SΣ	1..*	BackboneElement	Product Quality Standard
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: Quality Standard
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Quality Benchmark Terminology (required)
property:Sterile	SΣ	1..1	BackboneElement	Sterile Product Indicator
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: Sterile Product Indicator
value[x]	SΣ	1..1	boolean	A value for the characteristic
component	SΣC	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 cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
Slices for modifierExtension	?!Σ	0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio	?!S	0..1	AmountRatio	Amount Ratio
type	SΣ	1..1	CodeableConcept	Product Part Type
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Product Part Type Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
function	S	0..*	CodeableConceptTextOnly	Product Part Function Description
Slices for amount	SΣ	0..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, Open by value:code
amount:weight	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Product Part Total Weight Numeric
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	Product Part Total Weight Numeric UOM
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Product Part Content Percent
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	Product Part Content Percent UOM
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Binding: Percentage Units (required)
constituent	SΣC	1..*	BackboneElement	Product Part Ingredient Component Function Category cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
textualStrength	S	0..1	(Complex)	Original Text that represents the data as seen/selected/uttered originally URL: http://hl7.org/fhir/StructureDefinition/originalText
id		0..1	id	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"http://hl7.org/fhir/StructureDefinition/originalText"
value[x]		1..1	string	Textual Strength
Slices for modifierExtension	?!Σ	0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio	?!S	0..1	AmountRatio	Amount Ratio
Slices for amount	SΣ	1..2	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight	SΣ	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Product Part Ingredient Amount Numeric
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	Product Part Ingredient Amount Numeric UOM
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	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Product Part Ingredient Content Percent
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	Product Part Ingredient Content Percent UOM
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Binding: Percentage Units (required)
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..1	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text	SΣ	0..1	string	Plain text representation of the concept
Slices for function	SΣ	1..2	CodeableConcept	The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:$this
function:Category	SΣ	1..1	CodeableConcept	The function of this constituent within the component e.g. binder Binding: Drug Product Component Function Category Terminology (required)
function:Function	SΣ	0..1	CodeableConcept	Product Part Ingredient Function Binding: Excipient Function Terminology (required)
hasIngredient	S	1..1	LiteralCodeableReference(Drug Product Component) {b}	Reference to a resource or a concept
Slices for property	SΣ	2..*	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:RelsProf	SΣ	1..1	BackboneElement	Product Part Release Profile
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 Release Profile
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Release Profile Terminology (required)
property:RelsMech	SΣ	0..1	BackboneElement	Product Part Release Mechanism
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 Release Mechanism
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatPurpose	SΣ	0..*	BackboneElement	Coating Product Part Purpose
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: Coating Product Part Purpose
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Coating Purpose Terminology (required)
property:Color	SΣ	0..1	BackboneElement	Product Part Color Description
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 Color Description
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:OvrRelsProf.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsProf.value[x]	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.property:OvrRelsMech.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsMech.value[x]	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.property:CoatInd.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:LayCnt.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:LayCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:CapClass.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:CapClass.value[x]	required	PqcmcCapsuleClassificationCategory http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category from this IG
ManufacturedItemDefinition.property:CapConCnt.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:CapConCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:Schematic.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:WgtTyp.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:WgtTyp.value[x]	required	PqcmcStrengthTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology from this IG
ManufacturedItemDefinition.property:TotWgtNum.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtNum.value[x]	extensible	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.value[x]	extensible	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:TotWgtTxt.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:QualStd.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:QualStd.value[x]	required	PqcmcQualityBenchmarkTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology from this IG
ManufacturedItemDefinition.property:Sterile.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.type.coding	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount:weight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:weight.code	required	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:weight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:weight.code	required	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.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.constituent.function:Category	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
ManufacturedItemDefinition.component.constituent.function:Function	required	PqcmcExcipientFunctionTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology 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:RelsProf.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.value[x]	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.component.property:RelsMech.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsMech.value[x]	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.component.property:CoatPurpose.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:CoatPurpose.value[x]	required	PqcmcCoatingPurpose http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose from this IG
ManufacturedItemDefinition.component.property:Color.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
att-1	error	ManufacturedItemDefinition.property:Schematic.value[x]	If the Attachment has data, it SHALL have a contentType : data.empty() or contentType.exists()
cmc-amount-ratio-or-quantity	error	ManufacturedItemDefinition.component, ManufacturedItemDefinition.component.constituent	The amount ratio extension and an amount with a non-percentage unit are mutually exclusive : defineVariable('system','http://unitsofmeasure.org').select( modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio') .union( amount.where( system = %system and code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units') ) ).count() = 1 )
cmc-arbitrary-unit-text-required	error	ManufacturedItemDefinition	BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( property.where( type.coding.exists( system = %system and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = %system and code = 'C75765') ).exists() implies property.where( type = 'Total Weight Textual' ).exists())
cmc-capsule-classification-required	error	ManufacturedItemDefinition	when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154433' ) and component.type.coding.exists( system = %system and code = 'C203897' ) implies property.where( type.text = 'Capsule Classification Category' ).exists())
cmc-capsule-count-required	error	ManufacturedItemDefinition	Capsule constituent count is required when the dosage form is 'Capsule' : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and code = 'C154433') implies property.where(type.text = 'Capsule Constituent Count').exists())
cmc-coating-indication-required	error	ManufacturedItemDefinition	Coating indication is required when the dosage form is a tablet, lozenge or capsule : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.text = 'Coating Indicator').exists())
cmc-component-id-ref	error	ManufacturedItemDefinition	If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( component.select( property.where( type.text = 'Product Part Identifier Reference' ).select(value) ).all( text in %context.component.select( property.where( type.text = 'Product Part Identifier' ).select(value.text) ) ) and component.where( property.where( type.text = 'Product Part Identifier Reference' ).select(value.text) = property.where( type.text = 'Product Part Identifier' ).select(value.text) ).exists().not() )
cmc-ingredient-functions	error	ManufacturedItemDefinition.component.constituent	If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists() implies function.coding.code.count() = 2
cmc-tablet-bead-count-required	error	ManufacturedItemDefinition	Tablet bead count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Bead Type Count' ).exists())
cmc-tablet-layer-count-required	error	ManufacturedItemDefinition	Tablet layer count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Layer Count' ).exists())
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()
qty-3	error	ManufacturedItemDefinition.property:TotWgtDen.value[x]	If a code for the unit is present, the system SHALL also be present : code.empty() or system.exists()
sqty-1	error	ManufacturedItemDefinition.property:TotWgtDen.value[x]	The comparator is not used on a SimpleQuantity : comparator.empty()

This structure is derived from ManufacturedItemDefinition

Summary

Mandatory: 28 elements(24 nested mandatory elements)
Must-Support: 86 elements

Structures

This structure refers to these other structures:

• Analysis Graphic (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-attachment)
• Attached Document (PDF) (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-pdf-attachment)
• SimpleQuantity (http://hl7.org/fhir/StructureDefinition/SimpleQuantity)
• Text Only Codeable Concept (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only)
• Literal Coded Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference)
• Drug Product Component (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio (Modifier)
• http://hl7.org/fhir/StructureDefinition/originalText

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
• The element 1 is sliced based on the value of ManufacturedItemDefinition.component.constituent.amount
• The element 1 is sliced based on the value of ManufacturedItemDefinition.component.constituent.function (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	C	0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory cmc-component-id-ref: If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself
identifier	S	0..1	Identifier	Unique identifier
status	S	1..1	code	draft | active | retired | unknown
name	S	0..1	string	Product Proprietary Name | Product Non-proprietary Name
manufacturedDoseForm		1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required)
Slices for property	S	6..*	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:OvrRelsProf	S	1..1	BackboneElement	Product Overall Release Profile
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Overall Release Profile
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Release Profile Terminology (required)
property:OvrRelsMech	S	0..1	BackboneElement	Product Overall Release Mechanism
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Overall Release Mechanism
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatInd	S	0..1	BackboneElement	Product Coating Indicator
type
text		0..1	string	Plain text representation of the concept Required Pattern: Coating Indicator
value[x]	S	1..1	boolean	A value for the characteristic
property:LayCnt	S	0..1	BackboneElement	Product Tablet Layer Count
type
text		0..1	string	Plain text representation of the concept Required Pattern: Tablet Layer Count
value[x]	S	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
value	S	1..1	decimal	Numerical value (with implicit precision)
property:BeaTypCnt	S	0..1	BackboneElement	Tablet Bead Type Count
type
text		0..1	string	Plain text representation of the concept Required Pattern: Tablet Bead Type Count
value[x]	S	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
value	S	1..1	decimal	Numerical value (with implicit precision)
property:CapClass	S	0..1	BackboneElement	Capsule Shell Part Classification Category
type
text		0..1	string	Plain text representation of the concept Required Pattern: Capsule Classification Category
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Capsule Shell Classification Terminology (required)
property:CapConCnt	S	0..1	BackboneElement	Product Capsule Constituent Count
type
text		0..1	string	Plain text representation of the concept Required Pattern: Capsule Constituent Count
value[x]	S	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
value	S	1..1	decimal	Numerical value (with implicit precision)
property:Schematic	S	1..*	BackboneElement	Product Schematic
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Schematic
value[x]	S	1..1	GraphicAttachment, PDFAttachment	Content in a format defined elsewhere
property:WgtTyp	S	1..1	BackboneElement	Product Weight Type
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Weight Type
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Strength Type Terminology (required)
property:TotWgtNum	S	1..1	BackboneElement	Product Total Weight Numeric Numerator
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Total Weight Numeric Numerator
value[x]	S	1..1	Quantity	A value for the characteristic Binding: Units Of Measure (extensible)
comparator	S	0..1	code	Product Total Weight Operator
property:TotWgtDen	S	0..1	BackboneElement	Product Total Weight Numeric Denominator
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Total Weight Numeric Denominator
value[x]	S	1..1	SimpleQuantity	A fixed quantity (no comparator) Binding: Units Of Measure (extensible)
value	S	1..1	decimal	Numerical value (with implicit precision)
property:TotWgtTxt	S	0..1	BackboneElement	Product Total Weight Textual
type
text		0..1	string	Plain text representation of the concept Required Pattern: Total Weight Textual
value[x]	S	1..1	markdown	A value for the characteristic
property:QualStd	S	1..*	BackboneElement	Product Quality Standard
type
text		0..1	string	Plain text representation of the concept Required Pattern: Quality Standard
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Quality Benchmark Terminology (required)
property:Sterile	S	1..1	BackboneElement	Sterile Product Indicator
type
text		0..1	string	Plain text representation of the concept Required Pattern: Sterile Product Indicator
value[x]	S	1..1	boolean	A value for the characteristic
component	SC	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 cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive
Slices for modifierExtension		0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio	S	0..1	AmountRatio	Amount Ratio
type	S	1..1	CodeableConcept	Product Part Type
coding		0..*	Coding	Code defined by a terminology system Binding: Product Part Type Terminology (required)
function	S	0..*	CodeableConceptTextOnly	Product Part Function Description
Slices for amount	S	0..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, Open by value:code
amount:weight	S	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Product Part Total Weight Numeric
unit	S	1..1	string	Product Part Total Weight Numeric UOM
code		0..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	S	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Product Part Content Percent
unit	S	1..1	string	Product Part Content Percent UOM
code		0..1	code	Coded form of the unit Binding: Percentage Units (required)
constituent	SC	1..*	BackboneElement	Product Part Ingredient Component Function Category cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
textualStrength	S	0..1	(Complex)	Original Text that represents the data as seen/selected/uttered originally URL: http://hl7.org/fhir/StructureDefinition/originalText
value[x]		1..1	string	Textual Strength
Slices for modifierExtension		0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio	S	0..1	AmountRatio	Amount Ratio
Slices for amount	S	1..2	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight	S	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Product Part Ingredient Amount Numeric
unit	S	1..1	string	Product Part Ingredient Amount Numeric UOM
code	S	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	S	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Product Part Ingredient Content Percent
unit	S	1..1	string	Product Part Ingredient Content Percent UOM
code		0..1	code	Coded form of the unit Binding: Percentage Units (required)
location	S	0..*	CodeableConcept	Product Part Ingredient Physical Location
coding	S	1..1	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text	S	0..1	string	Plain text representation of the concept
Slices for function	S	1..2	CodeableConcept	The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:$this
function:Category	S	1..1	CodeableConcept	The function of this constituent within the component e.g. binder Binding: Drug Product Component Function Category Terminology (required)
function:Function	S	0..1	CodeableConcept	Product Part Ingredient Function Binding: Excipient Function Terminology (required)
hasIngredient	S	1..1	LiteralCodeableReference(Drug Product Component) {b}	Reference to a resource or a concept
Slices for property	S	2..*	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:RelsProf	S	1..1	BackboneElement	Product Part Release Profile
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Release Profile
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Release Profile Terminology (required)
property:RelsMech	S	0..1	BackboneElement	Product Part Release Mechanism
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Release Mechanism
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatPurpose	S	0..*	BackboneElement	Coating Product Part Purpose
type
text		0..1	string	Plain text representation of the concept Required Pattern: Coating Product Part Purpose
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Coating Purpose Terminology (required)
property:Color	S	0..1	BackboneElement	Product Part Color Description
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Color Description
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:OvrRelsProf.value[x]	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.property:OvrRelsMech.value[x]	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.property:CapClass.value[x]	required	PqcmcCapsuleClassificationCategory http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category from this IG
ManufacturedItemDefinition.property:WgtTyp.value[x]	required	PqcmcStrengthTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology from this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x]	extensible	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:TotWgtDen.value[x]	extensible	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:QualStd.value[x]	required	PqcmcQualityBenchmarkTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology from this IG
ManufacturedItemDefinition.component.type.coding	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount:weight.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:weight.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.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.constituent.function:Category	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
ManufacturedItemDefinition.component.constituent.function:Function	required	PqcmcExcipientFunctionTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology from this IG
ManufacturedItemDefinition.component.property:RelsProf.value[x]	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.component.property:RelsMech.value[x]	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.component.property:CoatPurpose.value[x]	required	PqcmcCoatingPurpose http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-amount-ratio-or-quantity	error	ManufacturedItemDefinition.component, ManufacturedItemDefinition.component.constituent	The amount ratio extension and an amount with a non-percentage unit are mutually exclusive : defineVariable('system','http://unitsofmeasure.org').select( modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio') .union( amount.where( system = %system and code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units') ) ).count() = 1 )
cmc-arbitrary-unit-text-required	error	ManufacturedItemDefinition	BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( property.where( type.coding.exists( system = %system and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = %system and code = 'C75765') ).exists() implies property.where( type = 'Total Weight Textual' ).exists())
cmc-capsule-classification-required	error	ManufacturedItemDefinition	when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154433' ) and component.type.coding.exists( system = %system and code = 'C203897' ) implies property.where( type.text = 'Capsule Classification Category' ).exists())
cmc-capsule-count-required	error	ManufacturedItemDefinition	Capsule constituent count is required when the dosage form is 'Capsule' : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and code = 'C154433') implies property.where(type.text = 'Capsule Constituent Count').exists())
cmc-coating-indication-required	error	ManufacturedItemDefinition	Coating indication is required when the dosage form is a tablet, lozenge or capsule : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.text = 'Coating Indicator').exists())
cmc-component-id-ref	error	ManufacturedItemDefinition	If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( component.select( property.where( type.text = 'Product Part Identifier Reference' ).select(value) ).all( text in %context.component.select( property.where( type.text = 'Product Part Identifier' ).select(value.text) ) ) and component.where( property.where( type.text = 'Product Part Identifier Reference' ).select(value.text) = property.where( type.text = 'Product Part Identifier' ).select(value.text) ).exists().not() )
cmc-ingredient-functions	error	ManufacturedItemDefinition.component.constituent	If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists() implies function.coding.code.count() = 2
cmc-tablet-bead-count-required	error	ManufacturedItemDefinition	Tablet bead count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Bead Type Count' ).exists())
cmc-tablet-layer-count-required	error	ManufacturedItemDefinition	Tablet layer count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Layer Count' ).exists())

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition	C	0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory cmc-component-id-ref: If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself
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	Unique identifier
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name	SΣ	0..1	string	Product Proprietary Name | Product Non-proprietary Name
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required)
Slices for property	SΣ	6..*	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:OvrRelsProf	SΣ	1..1	BackboneElement	Product Overall Release Profile
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 Overall Release Profile
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Release Profile Terminology (required)
property:OvrRelsMech	SΣ	0..1	BackboneElement	Product Overall Release Mechanism
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 Overall Release Mechanism
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatInd	SΣ	0..1	BackboneElement	Product Coating Indicator
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: Coating Indicator
value[x]	SΣ	1..1	boolean	A value for the characteristic
property:LayCnt	SΣ	0..1	BackboneElement	Product Tablet Layer Count
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: Tablet Layer Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
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.
property:BeaTypCnt	SΣ	0..1	BackboneElement	Tablet Bead Type Count
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: Tablet Bead Type Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
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.
property:CapClass	SΣ	0..1	BackboneElement	Capsule Shell Part Classification Category
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: Capsule Classification Category
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Capsule Shell Classification Terminology (required)
property:CapConCnt	SΣ	0..1	BackboneElement	Product Capsule Constituent Count
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: Capsule Constituent Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
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.
property:Schematic	SΣ	1..*	BackboneElement	Product Schematic
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 Schematic
value[x]	SC	1..1	GraphicAttachment, PDFAttachment	Content in a format defined elsewhere att-1: If the Attachment has data, it SHALL have a contentType
property:WgtTyp	SΣ	1..1	BackboneElement	Product Weight Type
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 Weight Type
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Strength Type Terminology (required)
property:TotWgtNum	SΣ	1..1	BackboneElement	Product Total Weight Numeric Numerator
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 Total Weight Numeric Numerator
value[x]	SΣ	1..1	Quantity	A value for the characteristic Binding: Units Of Measure (extensible)
comparator	?!SΣ	0..1	code	Product Total Weight Operator Binding: QuantityComparator (required): How the Quantity should be understood and represented.
property:TotWgtDen	SΣ	0..1	BackboneElement	Product Total Weight Numeric Denominator
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 Total Weight Numeric Denominator
value[x]	SC	1..1	SimpleQuantity	A fixed quantity (no comparator) Binding: Units Of Measure (extensible) qty-3: If a code for the unit is present, the system SHALL also be present sqty-1: The comparator is not used on a SimpleQuantity
value	SΣ	1..1	decimal	Numerical value (with implicit precision)
property:TotWgtTxt	SΣ	0..1	BackboneElement	Product Total Weight Textual
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: Total Weight Textual
value[x]	SΣ	1..1	markdown	A value for the characteristic
property:QualStd	SΣ	1..*	BackboneElement	Product Quality Standard
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: Quality Standard
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Quality Benchmark Terminology (required)
property:Sterile	SΣ	1..1	BackboneElement	Sterile Product Indicator
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: Sterile Product Indicator
value[x]	SΣ	1..1	boolean	A value for the characteristic
component	SΣC	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 cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive
Slices for modifierExtension	?!Σ	0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio	?!S	0..1	AmountRatio	Amount Ratio
type	SΣ	1..1	CodeableConcept	Product Part Type
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Product Part Type Terminology (required)
function	S	0..*	CodeableConceptTextOnly	Product Part Function Description
Slices for amount	SΣ	0..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, Open by value:code
amount:weight	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Product Part Total Weight Numeric
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	Product Part Total Weight Numeric UOM
code	ΣC	0..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Product Part Content Percent
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	Product Part Content Percent UOM
code	ΣC	0..1	code	Coded form of the unit Binding: Percentage Units (required)
constituent	SΣC	1..*	BackboneElement	Product Part Ingredient Component Function Category cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
textualStrength	S	0..1	(Complex)	Original Text that represents the data as seen/selected/uttered originally URL: http://hl7.org/fhir/StructureDefinition/originalText
extension		0..0
url		1..1	uri	"http://hl7.org/fhir/StructureDefinition/originalText"
value[x]		1..1	string	Textual Strength
Slices for modifierExtension	?!Σ	0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio	?!S	0..1	AmountRatio	Amount Ratio
Slices for amount	SΣ	1..2	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight	SΣ	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Product Part Ingredient Amount Numeric
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	Product Part Ingredient Amount Numeric UOM
code	SΣC	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	SΣ	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value	SΣ	1..1	decimal	Product Part Ingredient Content Percent
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	Product Part Ingredient Content Percent UOM
code	ΣC	0..1	code	Coded form of the unit Binding: Percentage Units (required)
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location
coding	SΣ	1..1	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text	SΣ	0..1	string	Plain text representation of the concept
Slices for function	SΣ	1..2	CodeableConcept	The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:$this
function:Category	SΣ	1..1	CodeableConcept	The function of this constituent within the component e.g. binder Binding: Drug Product Component Function Category Terminology (required)
function:Function	SΣ	0..1	CodeableConcept	Product Part Ingredient Function Binding: Excipient Function Terminology (required)
hasIngredient	S	1..1	LiteralCodeableReference(Drug Product Component) {b}	Reference to a resource or a concept
Slices for property	SΣ	2..*	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:RelsProf	SΣ	1..1	BackboneElement	Product Part Release Profile
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 Release Profile
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Release Profile Terminology (required)
property:RelsMech	SΣ	0..1	BackboneElement	Product Part Release Mechanism
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 Release Mechanism
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatPurpose	SΣ	0..*	BackboneElement	Coating Product Part Purpose
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: Coating Product Part Purpose
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Coating Purpose Terminology (required)
property:Color	SΣ	0..1	BackboneElement	Product Part Color Description
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 Color Description
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:OvrRelsProf.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsProf.value[x]	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.property:OvrRelsMech.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsMech.value[x]	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.property:CoatInd.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:LayCnt.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:LayCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:CapClass.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:CapClass.value[x]	required	PqcmcCapsuleClassificationCategory http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category from this IG
ManufacturedItemDefinition.property:CapConCnt.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:CapConCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:Schematic.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:WgtTyp.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:WgtTyp.value[x]	required	PqcmcStrengthTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology from this IG
ManufacturedItemDefinition.property:TotWgtNum.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtNum.value[x]	extensible	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.value[x]	extensible	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:TotWgtTxt.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:QualStd.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:QualStd.value[x]	required	PqcmcQualityBenchmarkTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology from this IG
ManufacturedItemDefinition.property:Sterile.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.type.coding	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount:weight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:weight.code	required	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:weight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:weight.code	required	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.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.constituent.function:Category	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
ManufacturedItemDefinition.component.constituent.function:Function	required	PqcmcExcipientFunctionTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology 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:RelsProf.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.value[x]	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.component.property:RelsMech.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsMech.value[x]	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.component.property:CoatPurpose.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:CoatPurpose.value[x]	required	PqcmcCoatingPurpose http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose from this IG
ManufacturedItemDefinition.component.property:Color.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
att-1	error	ManufacturedItemDefinition.property:Schematic.value[x]	If the Attachment has data, it SHALL have a contentType : data.empty() or contentType.exists()
cmc-amount-ratio-or-quantity	error	ManufacturedItemDefinition.component, ManufacturedItemDefinition.component.constituent	The amount ratio extension and an amount with a non-percentage unit are mutually exclusive : defineVariable('system','http://unitsofmeasure.org').select( modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio') .union( amount.where( system = %system and code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units') ) ).count() = 1 )
cmc-arbitrary-unit-text-required	error	ManufacturedItemDefinition	BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( property.where( type.coding.exists( system = %system and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = %system and code = 'C75765') ).exists() implies property.where( type = 'Total Weight Textual' ).exists())
cmc-capsule-classification-required	error	ManufacturedItemDefinition	when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154433' ) and component.type.coding.exists( system = %system and code = 'C203897' ) implies property.where( type.text = 'Capsule Classification Category' ).exists())
cmc-capsule-count-required	error	ManufacturedItemDefinition	Capsule constituent count is required when the dosage form is 'Capsule' : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and code = 'C154433') implies property.where(type.text = 'Capsule Constituent Count').exists())
cmc-coating-indication-required	error	ManufacturedItemDefinition	Coating indication is required when the dosage form is a tablet, lozenge or capsule : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.text = 'Coating Indicator').exists())
cmc-component-id-ref	error	ManufacturedItemDefinition	If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( component.select( property.where( type.text = 'Product Part Identifier Reference' ).select(value) ).all( text in %context.component.select( property.where( type.text = 'Product Part Identifier' ).select(value.text) ) ) and component.where( property.where( type.text = 'Product Part Identifier Reference' ).select(value.text) = property.where( type.text = 'Product Part Identifier' ).select(value.text) ).exists().not() )
cmc-ingredient-functions	error	ManufacturedItemDefinition.component.constituent	If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists() implies function.coding.code.count() = 2
cmc-tablet-bead-count-required	error	ManufacturedItemDefinition	Tablet bead count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Bead Type Count' ).exists())
cmc-tablet-layer-count-required	error	ManufacturedItemDefinition	Tablet layer count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Layer Count' ).exists())
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()
qty-3	error	ManufacturedItemDefinition.property:TotWgtDen.value[x]	If a code for the unit is present, the system SHALL also be present : code.empty() or system.exists()
sqty-1	error	ManufacturedItemDefinition.property:TotWgtDen.value[x]	The comparator is not used on a SimpleQuantity : comparator.empty()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition	C	0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory cmc-component-id-ref: If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself
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	Unique identifier
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name	SΣ	0..1	string	Product Proprietary Name | 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	Σ	0..*	Reference(Organization)	Manufacturer of the item, one of several possible
marketingStatus	Σ	0..*	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
ingredient	Σ	0..*	CodeableConcept	The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Slices for property	SΣ	6..*	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:OvrRelsProf	SΣ	1..1	BackboneElement	Product Overall Release Profile
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 Overall Release Profile
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Release Profile Terminology (required)
property:OvrRelsMech	SΣ	0..1	BackboneElement	Product Overall Release Mechanism
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 Overall Release Mechanism
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatInd	SΣ	0..1	BackboneElement	Product Coating Indicator
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: Coating Indicator
value[x]	SΣ	1..1	boolean	A value for the characteristic
property:LayCnt	SΣ	0..1	BackboneElement	Product Tablet Layer Count
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: Tablet Layer Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
value		0..1	decimal	Numerical value (with implicit precision)
comparator		0..1	code	< | <= | >= | > | ad - how to understand the value
unit		0..1	string	Unit representation
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
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	Coded form of the unit
property:BeaTypCnt	SΣ	0..1	BackboneElement	Tablet Bead Type Count
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: Tablet Bead Type Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
value		0..1	decimal	Numerical value (with implicit precision)
comparator		0..1	code	< | <= | >= | > | ad - how to understand the value
unit		0..1	string	Unit representation
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
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	Coded form of the unit
property:CapClass	SΣ	0..1	BackboneElement	Capsule Shell Part Classification Category
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: Capsule Classification Category
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Capsule Shell Classification Terminology (required)
property:CapConCnt	SΣ	0..1	BackboneElement	Product Capsule Constituent Count
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: Capsule Constituent Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
value		0..1	decimal	Numerical value (with implicit precision)
comparator		0..1	code	< | <= | >= | > | ad - how to understand the value
unit		0..1	string	Unit representation
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
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	Coded form of the unit
property:Schematic	SΣ	1..*	BackboneElement	Product Schematic
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 Schematic
value[x]	SC	1..1	GraphicAttachment, PDFAttachment	Content in a format defined elsewhere att-1: If the Attachment has data, it SHALL have a contentType
property:WgtTyp	SΣ	1..1	BackboneElement	Product Weight Type
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 Weight Type
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Strength Type Terminology (required)
property:TotWgtNum	SΣ	1..1	BackboneElement	Product Total Weight Numeric Numerator
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 Total Weight Numeric Numerator
value[x]	SΣ	1..1	Quantity	A value for the characteristic Binding: Units Of Measure (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	Numerical value (with implicit precision)
comparator	?!SΣ	0..1	code	Product Total Weight Operator 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	Coded form of the unit
property:TotWgtDen	SΣ	0..1	BackboneElement	Product Total Weight Numeric Denominator
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 Total Weight Numeric Denominator
value[x]	SC	1..1	SimpleQuantity	A fixed quantity (no comparator) Binding: Units Of Measure (extensible) qty-3: If a code for the unit is present, the system SHALL also be present sqty-1: The comparator is not used on a SimpleQuantity
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)
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit
property:TotWgtTxt	SΣ	0..1	BackboneElement	Product Total Weight Textual
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: Total Weight Textual
value[x]	SΣ	1..1	markdown	A value for the characteristic
property:QualStd	SΣ	1..*	BackboneElement	Product Quality Standard
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: Quality Standard
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Quality Benchmark Terminology (required)
property:Sterile	SΣ	1..1	BackboneElement	Sterile Product Indicator
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: Sterile Product Indicator
value[x]	SΣ	1..1	boolean	A value for the characteristic
component	SΣC	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 cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
Slices for modifierExtension	?!Σ	0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio	?!S	0..1	AmountRatio	Amount Ratio
type	SΣ	1..1	CodeableConcept	Product Part Type
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Product Part Type Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
function	S	0..*	CodeableConceptTextOnly	Product Part Function Description
Slices for amount	SΣ	0..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, Open by value:code
amount:weight	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Product Part Total Weight Numeric
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	Product Part Total Weight Numeric UOM
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent	SΣ	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Product Part Content Percent
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	Product Part Content Percent UOM
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Binding: Percentage Units (required)
constituent	SΣC	1..*	BackboneElement	Product Part Ingredient Component Function Category cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
textualStrength	S	0..1	(Complex)	Original Text that represents the data as seen/selected/uttered originally URL: http://hl7.org/fhir/StructureDefinition/originalText
id		0..1	id	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"http://hl7.org/fhir/StructureDefinition/originalText"
value[x]		1..1	string	Textual Strength
Slices for modifierExtension	?!Σ	0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio	?!S	0..1	AmountRatio	Amount Ratio
Slices for amount	SΣ	1..2	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight	SΣ	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Product Part Ingredient Amount Numeric
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	Product Part Ingredient Amount Numeric UOM
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	0..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Product Part Ingredient Content Percent
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	Product Part Ingredient Content Percent UOM
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Binding: Percentage Units (required)
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..1	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text	SΣ	0..1	string	Plain text representation of the concept
Slices for function	SΣ	1..2	CodeableConcept	The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:$this
function:Category	SΣ	1..1	CodeableConcept	The function of this constituent within the component e.g. binder Binding: Drug Product Component Function Category Terminology (required)
function:Function	SΣ	0..1	CodeableConcept	Product Part Ingredient Function Binding: Excipient Function Terminology (required)
hasIngredient	S	1..1	LiteralCodeableReference(Drug Product Component) {b}	Reference to a resource or a concept
Slices for property	SΣ	2..*	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:RelsProf	SΣ	1..1	BackboneElement	Product Part Release Profile
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 Release Profile
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Release Profile Terminology (required)
property:RelsMech	SΣ	0..1	BackboneElement	Product Part Release Mechanism
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 Release Mechanism
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatPurpose	SΣ	0..*	BackboneElement	Coating Product Part Purpose
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: Coating Product Part Purpose
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: Coating Purpose Terminology (required)
property:Color	SΣ	0..1	BackboneElement	Product Part Color Description
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 Color Description
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:OvrRelsProf.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsProf.value[x]	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.property:OvrRelsMech.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsMech.value[x]	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.property:CoatInd.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:LayCnt.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:LayCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:CapClass.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:CapClass.value[x]	required	PqcmcCapsuleClassificationCategory http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category from this IG
ManufacturedItemDefinition.property:CapConCnt.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:CapConCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:Schematic.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:WgtTyp.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:WgtTyp.value[x]	required	PqcmcStrengthTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology from this IG
ManufacturedItemDefinition.property:TotWgtNum.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtNum.value[x]	extensible	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.value[x]	extensible	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
ManufacturedItemDefinition.property:TotWgtTxt.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:QualStd.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:QualStd.value[x]	required	PqcmcQualityBenchmarkTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology from this IG
ManufacturedItemDefinition.property:Sterile.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.type.coding	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount:weight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount:weight.code	required	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:weight.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:weight.code	required	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.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.constituent.function:Category	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
ManufacturedItemDefinition.component.constituent.function:Function	required	PqcmcExcipientFunctionTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology 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:RelsProf.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.value[x]	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.component.property:RelsMech.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsMech.value[x]	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.component.property:CoatPurpose.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:CoatPurpose.value[x]	required	PqcmcCoatingPurpose http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose from this IG
ManufacturedItemDefinition.component.property:Color.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
att-1	error	ManufacturedItemDefinition.property:Schematic.value[x]	If the Attachment has data, it SHALL have a contentType : data.empty() or contentType.exists()
cmc-amount-ratio-or-quantity	error	ManufacturedItemDefinition.component, ManufacturedItemDefinition.component.constituent	The amount ratio extension and an amount with a non-percentage unit are mutually exclusive : defineVariable('system','http://unitsofmeasure.org').select( modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio') .union( amount.where( system = %system and code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units') ) ).count() = 1 )
cmc-arbitrary-unit-text-required	error	ManufacturedItemDefinition	BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( property.where( type.coding.exists( system = %system and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = %system and code = 'C75765') ).exists() implies property.where( type = 'Total Weight Textual' ).exists())
cmc-capsule-classification-required	error	ManufacturedItemDefinition	when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154433' ) and component.type.coding.exists( system = %system and code = 'C203897' ) implies property.where( type.text = 'Capsule Classification Category' ).exists())
cmc-capsule-count-required	error	ManufacturedItemDefinition	Capsule constituent count is required when the dosage form is 'Capsule' : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and code = 'C154433') implies property.where(type.text = 'Capsule Constituent Count').exists())
cmc-coating-indication-required	error	ManufacturedItemDefinition	Coating indication is required when the dosage form is a tablet, lozenge or capsule : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.text = 'Coating Indicator').exists())
cmc-component-id-ref	error	ManufacturedItemDefinition	If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( component.select( property.where( type.text = 'Product Part Identifier Reference' ).select(value) ).all( text in %context.component.select( property.where( type.text = 'Product Part Identifier' ).select(value.text) ) ) and component.where( property.where( type.text = 'Product Part Identifier Reference' ).select(value.text) = property.where( type.text = 'Product Part Identifier' ).select(value.text) ).exists().not() )
cmc-ingredient-functions	error	ManufacturedItemDefinition.component.constituent	If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists() implies function.coding.code.count() = 2
cmc-tablet-bead-count-required	error	ManufacturedItemDefinition	Tablet bead count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Bead Type Count' ).exists())
cmc-tablet-layer-count-required	error	ManufacturedItemDefinition	Tablet layer count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Layer Count' ).exists())
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()
qty-3	error	ManufacturedItemDefinition.property:TotWgtDen.value[x]	If a code for the unit is present, the system SHALL also be present : code.empty() or system.exists()
sqty-1	error	ManufacturedItemDefinition.property:TotWgtDen.value[x]	The comparator is not used on a SimpleQuantity : comparator.empty()

This structure is derived from ManufacturedItemDefinition

Summary

Mandatory: 28 elements(24 nested mandatory elements)
Must-Support: 86 elements

Structures

This structure refers to these other structures:

• Analysis Graphic (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-attachment)
• Attached Document (PDF) (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-pdf-attachment)
• SimpleQuantity (http://hl7.org/fhir/StructureDefinition/SimpleQuantity)
• Text Only Codeable Concept (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only)
• Literal Coded Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference)
• Drug Product Component (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio (Modifier)
• http://hl7.org/fhir/StructureDefinition/originalText

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