Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.6 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

Resource Profile: Drug Product Batch Formula

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula Version: 1.1.6
Active as of 2024-09-22 Computable Name: BatchFormula
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.47

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

Usage:

Formal Views of Profile Content

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

This structure is derived from ManufacturedItemDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. ManufacturedItemDefinition ManufacturedItemDefinition
... meta
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... identifier S 0..1 Identifier optional user designated identifier
... status S 1..1 code draft | active | retired | unknown
... manufacturedDoseForm 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation)
Binding: Manufactured Dose Form Terminology (required)
... manufacturer S 0..* Reference(Basic Organization) Manufacturer of the item, one of several possible
... Slices for property S 2..* BackboneElement General characteristics of this item
Slice: Unordered, Closed by value:type
.... property:BatchSize S 1..1 BackboneElement General characteristics of this item
..... type S 1..1 CodeableConcept Batch Quantity
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: batchsize
....... display 1..1 string Representation defined by the system
Fixed Value: Batch Quantity
..... value[x] 0..1 Quantity A value for the characteristic
...... unit S 1..1 string Quantity UOM
...... code S 1..1 code Coded form of the unit
Binding: Units Of Measure (required)
.... property:BatchUtil S 1..* BackboneElement General characteristics of this item
..... type 1..1 CodeableConcept A code expressing the type of characteristic
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: BatchUtil
....... display 1..1 string Representation defined by the system
Fixed Value: Batch Utilization
..... value[x] S 1..1 CodeableConcept Batch Utilization
...... coding 0..* Coding Code defined by a terminology system
Binding: Batch utilization Terminology (required)
.... property:AddInfo S 0..1 BackboneElement General characteristics of this item
..... type S 1..1 CodeableConcept Batch Formula Additional Information
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: AddInfo
....... display 1..1 string Representation defined by the system
Fixed Value: Product Part Additional Information
..... value[x] 0..1 markdown A value for the characteristic
... component S 1..* BackboneElement Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup
.... type S 1..1 CodeableConcept Product Part Type
Binding: Product Part Type Terminology (required)
.... Slices for amount 2..2 Quantity The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
Slice: Unordered, Closed by value:code
..... amount:perBatch S 1..1 Quantity Component Quantity Per Batch
...... value S 1..1 decimal Numerical value (with implicit precision)
...... unit S 1..1 string Unit representation
...... code S 1..1 code Coded form of the unit
Binding: Non-Percentage Units (required)
..... amount:percent S 1..1 Quantity The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
...... value S 1..1 decimal Numerical value (with implicit precision)
...... unit S 1..1 string Unit representation
...... code S 1..1 code Coded form of the unit
Binding: Percentage Units (required)
.... constituent S 1..* BackboneElement A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... additional-info S 0..1 markdown Drug Product Constituent Additional Information
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
...... formulaIngredient S 0..1 (Complex) Product Batch Ingredient Extension
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension
..... Slices for amount S 2..2 Quantity The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
Slice: Unordered, Closed by value:code
...... amount:perBatch S 1..1 Quantity Component Quantity Per Batch
....... value S 1..1 decimal Numerical value (with implicit precision)
....... unit S 1..1 string Unit representation
....... code S 1..1 code Coded form of the unit
Binding: Non-Percentage Units (required)
...... amount:percent S 1..1 Quantity Quantity Percent
....... value S 1..1 decimal Numerical value (with implicit precision)
....... unit S 1..1 string Unit representation
....... code S 1..1 code Coded form of the unit
Binding: Percentage Units (required)
..... location S 0..* CodeableConcept Product Part Ingredient Physical Location
...... coding 0..* Coding Code defined by a terminology system
Binding: Ingredient Location Terminology (required)
..... hasIngredient S 1..1 CodeableReference(Drug Product Batch Formula Ingredient) The ingredient that is the constituent of the given component
.... Slices for property S 1..3 General characteristics of this component
Slice: Unordered, Closed by value:type
..... property:PPiD S 1..1 BackboneElement General characteristics of this component
...... type S 1..1 CodeableConcept A code expressing the type of characteristic
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: PPiD
........ display 1..1 string Representation defined by the system
Fixed Value: Product Part Identifier
...... value[x] S 1..1 CodeableConcept A value for the characteristic
....... text S 1..1 string Product Part Identifier
..... property:PPiDref S 0..1 BackboneElement General characteristics of this component
...... type S 1..1 CodeableConcept A code expressing the type of characteristic
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: PPiDref
........ display 1..1 string Representation defined by the system
Fixed Value: Product Part Identifier Reference
...... value[x] S 1..1 CodeableConcept A value for the characteristic
....... text S 1..1 string Product Part Identifier Reference
..... property:AddInfo S 0..1 BackboneElement General characteristics of this component
...... type S 1..1 CodeableConcept Batch Component Additional Information
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: AddInfo
........ display 1..1 string Representation defined by the system
Fixed Value: Product Part Additional Information
...... value[x] 0..1 markdown A value for the characteristic

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
ManufacturedItemDefinition.manufacturedDoseFormrequiredPqcmcManufacturedDoseFormTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology
from this IG
ManufacturedItemDefinition.property:BatchSize.value[x].coderequiredPqcmcUnitsMeasure
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure
from this IG
ManufacturedItemDefinition.property:BatchUtil.value[x].codingrequiredPqcmcBatchUtilizationTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology
from this IG
ManufacturedItemDefinition.component.typerequiredPqcmcProductPartType
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type
from this IG
ManufacturedItemDefinition.component.amount:perBatch.coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
from this IG
ManufacturedItemDefinition.component.amount:percent.coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
from this IG
ManufacturedItemDefinition.component.constituent.amount:perBatch.coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
from this IG
ManufacturedItemDefinition.component.constituent.amount:percent.coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
from this IG
ManufacturedItemDefinition.component.constituent.location.codingrequiredPqcmcProductPartIngredientPhysicalLocation
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. ManufacturedItemDefinition 0..* ManufacturedItemDefinition The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... identifier SΣ 0..1 Identifier optional user designated identifier
... status ?!SΣ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... name SΣ 1..1 string Product Non-proprietary Name
... manufacturedDoseForm Σ 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation)
Binding: Manufactured Dose Form Terminology (required)
... manufacturer SΣ 0..* Reference(Basic Organization) Manufacturer of the item, one of several possible
... Slices for property SΣ 2..* BackboneElement General characteristics of this item
Slice: Unordered, Closed by value:type
.... property:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

.... property:BatchSize SΣ 1..1 BackboneElement General characteristics of this item
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type SΣ 1..1 CodeableConcept Batch Quantity
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.


Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: batchsize
....... display 1..1 string Representation defined by the system
Fixed Value: Batch Quantity
..... value[x] Σ 0..1 Quantity A value for the characteristic
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit SΣ 1..1 string Quantity UOM
...... code SΣC 1..1 code Coded form of the unit
Binding: Units Of Measure (required)
.... property:BatchUtil SΣ 1..* BackboneElement General characteristics of this item
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.


Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: BatchUtil
....... display 1..1 string Representation defined by the system
Fixed Value: Batch Utilization
..... value[x] SΣ 1..1 CodeableConcept Batch Utilization
...... coding Σ 0..* Coding Code defined by a terminology system
Binding: Batch utilization Terminology (required)
.... property:AddInfo SΣ 0..1 BackboneElement General characteristics of this item
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type SΣ 1..1 CodeableConcept Batch Formula Additional Information
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.


Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: AddInfo
....... display 1..1 string Representation defined by the system
Fixed Value: Product Part Additional Information
..... value[x] Σ 0..1 markdown A value for the characteristic
... component SΣ 1..* BackboneElement Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type SΣ 1..1 CodeableConcept Product Part Type
Binding: Product Part Type Terminology (required)
.... Slices for amount Σ 2..2 Quantity The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
Slice: Unordered, Closed by value:code
..... amount:perBatch SΣ 1..1 Quantity Component Quantity Per Batch
...... value SΣ 1..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit SΣ 1..1 string Unit representation
...... code SΣC 1..1 code Coded form of the unit
Binding: Non-Percentage Units (required)
..... amount:percent SΣ 1..1 Quantity The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
...... value SΣ 1..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit SΣ 1..1 string Unit representation
...... code SΣC 1..1 code Coded form of the unit
Binding: Percentage Units (required)
.... constituent SΣ 1..* BackboneElement A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... additional-info S 0..1 markdown Drug Product Constituent Additional Information
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
...... formulaIngredient S 0..1 (Complex) Product Batch Ingredient Extension
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... Slices for amount SΣ 2..2 Quantity The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
Slice: Unordered, Closed by value:code
...... amount:perBatch SΣ 1..1 Quantity Component Quantity Per Batch
....... value SΣ 1..1 decimal Numerical value (with implicit precision)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

....... unit SΣ 1..1 string Unit representation
....... code SΣC 1..1 code Coded form of the unit
Binding: Non-Percentage Units (required)
...... amount:percent SΣ 1..1 Quantity Quantity Percent
....... value SΣ 1..1 decimal Numerical value (with implicit precision)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

....... unit SΣ 1..1 string Unit representation
....... code SΣC 1..1 code Coded form of the unit
Binding: Percentage Units (required)
..... location SΣ 0..* CodeableConcept Product Part Ingredient Physical Location
...... coding Σ 0..* Coding Code defined by a terminology system
Binding: Ingredient Location Terminology (required)
..... hasIngredient SΣ 1..1 CodeableReference(Drug Product Batch Formula Ingredient) The ingredient that is the constituent of the given component
.... Slices for property SΣ 1..3 See property (ManufacturedItemDefinition) General characteristics of this component
Slice: Unordered, Closed by value:type
..... property:PPiD SΣ 1..1 BackboneElement General characteristics of this component
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... type SΣ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.


Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: PPiD
........ display 1..1 string Representation defined by the system
Fixed Value: Product Part Identifier
...... value[x] SΣ 1..1 CodeableConcept A value for the characteristic
....... text SΣ 1..1 string Product Part Identifier
..... property:PPiDref SΣ 0..1 BackboneElement General characteristics of this component
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... type SΣ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.


Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: PPiDref
........ display 1..1 string Representation defined by the system
Fixed Value: Product Part Identifier Reference
...... value[x] SΣ 1..1 CodeableConcept A value for the characteristic
....... text SΣ 1..1 string Product Part Identifier Reference
..... property:AddInfo SΣ 0..1 BackboneElement General characteristics of this component
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... type SΣ 1..1 CodeableConcept Batch Component Additional Information
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.


Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: AddInfo
........ display 1..1 string Representation defined by the system
Fixed Value: Product Part Additional Information
...... value[x] Σ 0..1 markdown A value for the characteristic

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
ManufacturedItemDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseFormrequiredPqcmcManufacturedDoseFormTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology
from this IG
ManufacturedItemDefinition.property.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.typeexamplePattern: batchsize("Batch Quantity")
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x].coderequiredPqcmcUnitsMeasure
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure
from this IG
ManufacturedItemDefinition.property:BatchUtil.typeexamplePattern: BatchUtil("Batch Utilization")
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.value[x].codingrequiredPqcmcBatchUtilizationTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology
from this IG
ManufacturedItemDefinition.property:AddInfo.typeexamplePattern: AddInfo("Product Part Additional Information")
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.component.typerequiredPqcmcProductPartType
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type
from this IG
ManufacturedItemDefinition.component.amount:perBatch.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
ManufacturedItemDefinition.component.amount:perBatch.coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
from this IG
ManufacturedItemDefinition.component.amount:percent.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
ManufacturedItemDefinition.component.amount:percent.coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
from this IG
ManufacturedItemDefinition.component.constituent.amount:perBatch.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:perBatch.coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
from this IG
ManufacturedItemDefinition.component.constituent.amount:percent.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:percent.coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
from this IG
ManufacturedItemDefinition.component.constituent.location.codingrequiredPqcmcProductPartIngredientPhysicalLocation
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location
from this IG
ManufacturedItemDefinition.component.property:PPiD.typeexamplePattern: PPiD("Product Part Identifier")
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiDref.typeexamplePattern: PPiDref("Product Part Identifier Reference")
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.typeexamplePattern: AddInfo("Product Part Additional Information")
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorManufacturedItemDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorManufacturedItemDefinitionIf 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-4errorManufacturedItemDefinitionIf 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-5errorManufacturedItemDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceManufacturedItemDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. ManufacturedItemDefinition 0..* ManufacturedItemDefinition The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..1 Identifier optional user designated identifier
... status ?!SΣ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... name SΣ 1..1 string Product Non-proprietary Name
... manufacturedDoseForm Σ 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation)
Binding: Manufactured Dose Form Terminology (required)
... unitOfPresentation Σ 0..1 CodeableConcept The “real-world” units in which the quantity of the item is described
Binding: UnitOfPresentation (example): The presentation type in which an administrable medicinal product is given to a patient.

... manufacturer SΣ 0..* Reference(Basic Organization) Manufacturer of the item, one of several possible
... marketingStatus Σ 0..* MarketingStatus Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
... ingredient Σ 0..* CodeableConcept The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.


... Slices for property SΣ 2..* BackboneElement General characteristics of this item
Slice: Unordered, Closed by value:type
.... property:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

..... value[x] Σ 0..1 A value for the characteristic
...... valueCodeableConcept CodeableConcept
...... valueQuantity Quantity
...... valueDate date
...... valueBoolean boolean
...... valueMarkdown markdown
...... valueAttachment Attachment
...... valueReference Reference(Binary)
.... property:BatchSize SΣ 1..1 BackboneElement General characteristics of this item
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type SΣ 1..1 CodeableConcept Batch Quantity
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.


Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: batchsize
....... display 1..1 string Representation defined by the system
Fixed Value: Batch Quantity
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] Σ 0..1 Quantity A value for the characteristic
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... value Σ 0..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit SΣ 1..1 string Quantity UOM
...... system ΣC 0..1 uri System that defines coded unit form
...... code SΣC 1..1 code Coded form of the unit
Binding: Units Of Measure (required)
.... property:BatchUtil SΣ 1..* BackboneElement General characteristics of this item
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.


Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: BatchUtil
....... display 1..1 string Representation defined by the system
Fixed Value: Batch Utilization
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] SΣ 1..1 CodeableConcept Batch Utilization
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
Binding: Batch utilization Terminology (required)
...... text Σ 0..1 string Plain text representation of the concept
.... property:AddInfo SΣ 0..1 BackboneElement General characteristics of this item
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type SΣ 1..1 CodeableConcept Batch Formula Additional Information
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.


Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: AddInfo
....... display 1..1 string Representation defined by the system
Fixed Value: Product Part Additional Information
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] Σ 0..1 markdown A value for the characteristic
... component SΣ 1..* BackboneElement Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type SΣ 1..1 CodeableConcept Product Part Type
Binding: Product Part Type Terminology (required)
.... function Σ 0..* CodeableConcept The function of this component within the item e.g. delivers active ingredient, masks taste
.... Slices for amount Σ 2..2 Quantity The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
Slice: Unordered, Closed by value:code
..... amount:perBatch SΣ 1..1 Quantity Component Quantity Per Batch
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... value SΣ 1..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit SΣ 1..1 string Unit representation
...... system ΣC 0..1 uri System that defines coded unit form
...... code SΣC 1..1 code Coded form of the unit
Binding: Non-Percentage Units (required)
..... amount:percent SΣ 1..1 Quantity The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... value SΣ 1..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit SΣ 1..1 string Unit representation
...... system ΣC 0..1 uri System that defines coded unit form
...... code SΣC 1..1 code Coded form of the unit
Binding: Percentage Units (required)
.... constituent SΣ 1..* BackboneElement A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... additional-info S 0..1 markdown Drug Product Constituent Additional Information
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
...... formulaIngredient S 0..1 (Complex) Product Batch Ingredient Extension
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... Slices for amount SΣ 2..2 Quantity The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
Slice: Unordered, Closed by value:code
...... amount:perBatch SΣ 1..1 Quantity Component Quantity Per Batch
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... value SΣ 1..1 decimal Numerical value (with implicit precision)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

....... unit SΣ 1..1 string Unit representation
....... system ΣC 0..1 uri System that defines coded unit form
....... code SΣC 1..1 code Coded form of the unit
Binding: Non-Percentage Units (required)
...... amount:percent SΣ 1..1 Quantity Quantity Percent
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... value SΣ 1..1 decimal Numerical value (with implicit precision)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

....... unit SΣ 1..1 string Unit representation
....... system ΣC 0..1 uri System that defines coded unit form
....... code SΣC 1..1 code Coded form of the unit
Binding: Percentage Units (required)
..... location SΣ 0..* CodeableConcept Product Part Ingredient Physical Location
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
Binding: Ingredient Location Terminology (required)
...... text Σ 0..1 string Plain text representation of the concept
..... function Σ 0..* CodeableConcept The function of this constituent within the component e.g. binder
..... hasIngredient SΣ 1..1 CodeableReference(Drug Product Batch Formula Ingredient) The ingredient that is the constituent of the given component
.... Slices for property SΣ 1..3 See property (ManufacturedItemDefinition) General characteristics of this component
Slice: Unordered, Closed by value:type
..... property:PPiD SΣ 1..1 BackboneElement General characteristics of this component
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... type SΣ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.


Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: PPiD
........ display 1..1 string Representation defined by the system
Fixed Value: Product Part Identifier
........ userSelected 0..1 boolean If this coding was chosen directly by the user
....... text 0..1 string Plain text representation of the concept
...... value[x] SΣ 1..1 CodeableConcept A value for the characteristic
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 0..* Coding Code defined by a terminology system
....... text SΣ 1..1 string Product Part Identifier
..... property:PPiDref SΣ 0..1 BackboneElement General characteristics of this component
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... type SΣ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.


Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: PPiDref
........ display 1..1 string Representation defined by the system
Fixed Value: Product Part Identifier Reference
........ userSelected 0..1 boolean If this coding was chosen directly by the user
....... text 0..1 string Plain text representation of the concept
...... value[x] SΣ 1..1 CodeableConcept A value for the characteristic
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 0..* Coding Code defined by a terminology system
....... text SΣ 1..1 string Product Part Identifier Reference
..... property:AddInfo SΣ 0..1 BackboneElement General characteristics of this component
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... type SΣ 1..1 CodeableConcept Batch Component Additional Information
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.


Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: AddInfo
........ display 1..1 string Representation defined by the system
Fixed Value: Product Part Additional Information
........ userSelected 0..1 boolean If this coding was chosen directly by the user
....... text 0..1 string Plain text representation of the concept
...... value[x] Σ 0..1 markdown A value for the characteristic
.... component Σ 0..* See component (ManufacturedItemDefinition) A component that this component contains or is made from

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
ManufacturedItemDefinition.meta.securityextensibleAllSecurityLabels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
ManufacturedItemDefinition.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
ManufacturedItemDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
ManufacturedItemDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseFormrequiredPqcmcManufacturedDoseFormTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology
from this IG
ManufacturedItemDefinition.unitOfPresentationexampleUnitOfPresentation
http://hl7.org/fhir/ValueSet/unit-of-presentation
from the FHIR Standard
ManufacturedItemDefinition.ingredientexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
ManufacturedItemDefinition.property.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.typeexamplePattern: batchsize("Batch Quantity")
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x].coderequiredPqcmcUnitsMeasure
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure
from this IG
ManufacturedItemDefinition.property:BatchUtil.typeexamplePattern: BatchUtil("Batch Utilization")
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.value[x].codingrequiredPqcmcBatchUtilizationTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology
from this IG
ManufacturedItemDefinition.property:AddInfo.typeexamplePattern: AddInfo("Product Part Additional Information")
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.component.typerequiredPqcmcProductPartType
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type
from this IG
ManufacturedItemDefinition.component.amount:perBatch.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
ManufacturedItemDefinition.component.amount:perBatch.coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
from this IG
ManufacturedItemDefinition.component.amount:percent.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
ManufacturedItemDefinition.component.amount:percent.coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
from this IG
ManufacturedItemDefinition.component.constituent.amount:perBatch.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:perBatch.coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
from this IG
ManufacturedItemDefinition.component.constituent.amount:percent.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:percent.coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
from this IG
ManufacturedItemDefinition.component.constituent.location.codingrequiredPqcmcProductPartIngredientPhysicalLocation
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location
from this IG
ManufacturedItemDefinition.component.property:PPiD.typeexamplePattern: PPiD("Product Part Identifier")
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiDref.typeexamplePattern: PPiDref("Product Part Identifier Reference")
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.typeexamplePattern: AddInfo("Product Part Additional Information")
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorManufacturedItemDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorManufacturedItemDefinitionIf 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-4errorManufacturedItemDefinitionIf 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-5errorManufacturedItemDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceManufacturedItemDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from ManufacturedItemDefinition

Summary

Mandatory: 27 elements(4 nested mandatory elements)
Must-Support: 49 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

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

Differential View

This structure is derived from ManufacturedItemDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. ManufacturedItemDefinition ManufacturedItemDefinition
... meta
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... identifier S 0..1 Identifier optional user designated identifier
... status S 1..1 code draft | active | retired | unknown
... manufacturedDoseForm 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation)
Binding: Manufactured Dose Form Terminology (required)
... manufacturer S 0..* Reference(Basic Organization) Manufacturer of the item, one of several possible
... Slices for property S 2..* BackboneElement General characteristics of this item
Slice: Unordered, Closed by value:type
.... property:BatchSize S 1..1 BackboneElement General characteristics of this item
..... type S 1..1 CodeableConcept Batch Quantity
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy