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 Ingredient

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient Version: 1.1.6
Active as of 2024-09-22 Computable Name: DrugProductIngredient
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.43

The amount details about the drug product ingredients in the batch. Use for Batch Formula.

Usage:

Formal Views of Profile Content

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

This structure is derived from Ingredient

NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient Ingredient
... meta
.... profile S 0..1 canonical(StructureDefinition) Profiles this resource claims to conform to
... identifier S 0..1 Identifier An identifier or code by which the ingredient can be referenced
... substance
.... code S 1..1 CodeableReference(Drug Substance Handle | Excipient Drug Substance) Ingredient Substance
.... Slices for strength S 2..2 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slice: Unordered, Closed by value:concentration.code
..... strength:perBatch S 1..1 BackboneElement Ingredient Total per Batch
...... concentration[x] S 1..1 Quantity The strength per unitary volume (or mass)
....... code S 1..1 code Coded form of the unit
Binding: Non-Percentage Units (required)
..... strength:percent S 1..1 BackboneElement Ingredient percent of Total Batch
...... concentration[x] S 1..1 Quantity The strength per unitary volume (or mass)
....... code S 1..1 code Coded form of the unit
Binding: Percentage Units (required)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Ingredient.substance.strength:perBatch.concentration[x].coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
from this IG
Ingredient.substance.strength:percent.concentration[x].coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient C 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 0..1 canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... identifier SΣ 0..1 Identifier An identifier or code by which the ingredient can be referenced
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... role Σ 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.

... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣC 1..1 CodeableReference(Drug Substance Handle | Excipient Drug Substance) Ingredient Substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

.... Slices for strength SΣ 2..2 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slice: Unordered, Closed by value:concentration.code
..... strength:All Slices Content/Rules for all slices
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... strength:perBatch SΣ 1..1 BackboneElement Ingredient Total per Batch
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... concentration[x] SΣ 1..1 Quantity The strength per unitary volume (or mass)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

....... code SΣC 1..1 code Coded form of the unit
Binding: Non-Percentage Units (required)
..... strength:percent SΣ 1..1 BackboneElement Ingredient percent of Total Batch
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... concentration[x] SΣ 1..1 Quantity The strength per unitary volume (or mass)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

....... code SΣC 1..1 code Coded form of the unit
Binding: Percentage Units (required)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Ingredient.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
Ingredient.roleexampleIngredientRole
http://hl7.org/fhir/ValueSet/ingredient-role
from the FHIR Standard
Ingredient.substance.codeexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
from this IG
Ingredient.substance.strength:percent.concentration[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
from this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorIngredientIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorIngredientIf 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-4errorIngredientIf 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-5errorIngredientIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceIngredientA 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()
ing-1errorIngredientIf an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
: Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2
NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient C 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
... 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..1 canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


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


... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... 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 An identifier or code by which the ingredient can be referenced
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... for Σ 0..* Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) The product which this ingredient is a constituent part of
... role Σ 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.

... function Σ 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: IngredientFunction (example): A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).


... group Σ 0..1 CodeableConcept A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
... allergenicIndicator ΣC 0..1 boolean If the ingredient is a known or suspected allergen
... comment 0..1 markdown A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
... manufacturer Σ 0..* BackboneElement An organization that manufactures this ingredient
.... 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
.... role Σ 0..1 code allowed | possible | actual
Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient.

.... manufacturer Σ 1..1 Reference(Organization) An organization that manufactures this ingredient
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... 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
.... code SΣC 1..1 CodeableReference(Drug Substance Handle | Excipient Drug Substance) Ingredient Substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

.... Slices for strength SΣ 2..2 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slice: Unordered, Closed by value:concentration.code
..... strength: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
...... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
....... presentationRatio Ratio
....... presentationRatioRange RatioRange
....... presentationCodeableConcept CodeableConcept
....... presentationQuantity Quantity
...... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
...... concentration[x] Σ 0..1 The strength per unitary volume (or mass)
....... concentrationRatio Ratio
....... concentrationRatioRange RatioRange
....... concentrationCodeableConcept CodeableConcept
....... concentrationQuantity Quantity
...... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
...... basis Σ 0..1 CodeableConcept A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes


...... referenceStrength Σ 0..* BackboneElement Strength expressed in terms of a reference substance
....... 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
....... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

....... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
........ strengthRatio Ratio
........ strengthRatioRange RatioRange
........ strengthQuantity Quantity
....... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
....... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes


..... strength:perBatch SΣ 1..1 BackboneElement Ingredient Total per Batch
...... 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
...... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
....... presentationRatio Ratio
....... presentationRatioRange RatioRange
....... presentationCodeableConcept CodeableConcept
....... presentationQuantity Quantity
...... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
...... concentration[x] SΣ 1..1 Quantity The strength per unitary volume (or mass)
....... 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 Σ 0..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)
...... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
...... basis Σ 0..1 CodeableConcept A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes


...... referenceStrength Σ 0..* BackboneElement Strength expressed in terms of a reference substance
....... 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
....... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

....... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
........ strengthRatio Ratio
........ strengthRatioRange RatioRange
........ strengthQuantity Quantity
....... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
....... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes


..... strength:percent SΣ 1..1 BackboneElement Ingredient percent of Total Batch
...... 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
...... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
....... presentationRatio Ratio
....... presentationRatioRange RatioRange
....... presentationCodeableConcept CodeableConcept
....... presentationQuantity Quantity
...... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
...... concentration[x] SΣ 1..1 Quantity The strength per unitary volume (or mass)
....... 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 Σ 0..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)
...... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
...... basis Σ 0..1 CodeableConcept A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes


...... referenceStrength Σ 0..* BackboneElement Strength expressed in terms of a reference substance
....... 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
....... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

....... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
........ strengthRatio Ratio
........ strengthRatioRange RatioRange
........ strengthQuantity Quantity
....... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
....... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes



doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Ingredient.meta.securityextensibleAllSecurityLabels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
Ingredient.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
Ingredient.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Ingredient.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
Ingredient.roleexampleIngredientRole
http://hl7.org/fhir/ValueSet/ingredient-role
from the FHIR Standard
Ingredient.functionexampleIngredientFunction
http://hl7.org/fhir/ValueSet/ingredient-function
from the FHIR Standard
Ingredient.manufacturer.rolerequiredIngredientManufacturerRole
http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0
from the FHIR Standard
Ingredient.substance.codeexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
Ingredient.substance.strength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
Ingredient.substance.strength.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
Ingredient.substance.strength.referenceStrength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
from this IG
Ingredient.substance.strength:perBatch.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
Ingredient.substance.strength:perBatch.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
Ingredient.substance.strength:perBatch.referenceStrength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
from this IG
Ingredient.substance.strength:percent.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
Ingredient.substance.strength:percent.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
Ingredient.substance.strength:percent.referenceStrength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorIngredientIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorIngredientIf 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-4errorIngredientIf 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-5errorIngredientIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceIngredientA 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()
ing-1errorIngredientIf an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
: Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2

This structure is derived from Ingredient

Summary

Mandatory: 6 elements
Must-Support: 10 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Ingredient.substance.strength (Closed)

Differential View

This structure is derived from Ingredient

NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient Ingredient
... meta
.... profile S 0..1 canonical(StructureDefinition) Profiles this resource claims to conform to
... identifier S 0..1 Identifier An identifier or code by which the ingredient can be referenced
... substance
.... code S 1..1 CodeableReference(Drug Substance Handle | Excipient Drug Substance) Ingredient Substance
.... Slices for strength S 2..2 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slice: Unordered, Closed by value:concentration.code
..... strength:perBatch S 1..1 BackboneElement Ingredient Total per Batch
...... concentration[x] S 1..1 Quantity The strength per unitary volume (or mass)
....... code S 1..1 code Coded form of the unit
Binding: Non-Percentage Units (required)
..... strength:percent S 1..1 BackboneElement Ingredient percent of Total Batch
...... concentration[x] S 1..1 Quantity The strength per unitary volume (or mass)
....... code S 1..1 code Coded form of the unit
Binding: Percentage Units (required)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Ingredient.substance.strength:perBatch.concentration[x].coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
from this IG
Ingredient.substance.strength:percent.concentration[x].coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
from this IG

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient C 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 0..1 canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... identifier SΣ 0..1 Identifier An identifier or code by which the ingredient can be referenced
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... role Σ 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.

... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣC 1..1 CodeableReference(Drug Substance Handle | Excipient Drug Substance) Ingredient Substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

.... Slices for strength SΣ 2..2 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slice: Unordered, Closed by value:concentration.code
..... strength:All Slices Content/Rules for all slices
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... strength:perBatch SΣ 1..1 BackboneElement Ingredient Total per Batch
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... concentration[x] SΣ 1..1 Quantity The strength per unitary volume (or mass)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

....... code SΣC 1..1 code Coded form of the unit
Binding: Non-Percentage Units (required)
..... strength:percent SΣ 1..1 BackboneElement Ingredient percent of Total Batch
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... concentration[x] SΣ 1..1 Quantity The strength per unitary volume (or mass)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

....... code SΣC 1..1 code Coded form of the unit
Binding: Percentage Units (required)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Ingredient.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
Ingredient.roleexampleIngredientRole
http://hl7.org/fhir/ValueSet/ingredient-role
from the FHIR Standard
Ingredient.substance.codeexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
from this IG
Ingredient.substance.strength:percent.concentration[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
from this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorIngredientIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorIngredientIf 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-4errorIngredientIf 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-5errorIngredientIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceIngredientA 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()
ing-1errorIngredientIf an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
: Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient C 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
... 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..1 canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


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


... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... 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 An identifier or code by which the ingredient can be referenced
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... for Σ 0..* Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) The product which this ingredient is a constituent part of
... role Σ 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.

... function Σ 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: IngredientFunction (example): A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).


... group Σ 0..1 CodeableConcept A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
... allergenicIndicator ΣC 0..1 boolean If the ingredient is a known or suspected allergen
... comment 0..1 markdown A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
... manufacturer Σ 0..* BackboneElement An organization that manufactures this ingredient
.... 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
.... role Σ 0..1 code allowed | possible | actual
Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient.

.... manufacturer Σ 1..1 Reference(Organization) An organization that manufactures this ingredient
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... 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
.... code SΣC 1..1 CodeableReference(Drug Substance Handle | Excipient Drug Substance) Ingredient Substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

.... Slices for strength SΣ 2..2 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slice: Unordered, Closed by value:concentration.code
..... strength: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
...... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
....... presentationRatio Ratio
....... presentationRatioRange RatioRange
....... presentationCodeableConcept CodeableConcept
....... presentationQuantity Quantity
...... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
...... concentration[x] Σ 0..1 The strength per unitary volume (or mass)
....... concentrationRatio Ratio
....... concentrationRatioRange RatioRange
....... concentrationCodeableConcept CodeableConcept
....... concentrationQuantity Quantity
...... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
...... basis Σ 0..1 CodeableConcept A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes


...... referenceStrength Σ 0..* BackboneElement Strength expressed in terms of a reference substance
....... 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
....... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

....... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
........ strengthRatio Ratio
........ strengthRatioRange RatioRange
........ strengthQuantity Quantity
....... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
....... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes


..... strength:perBatch SΣ 1..1 BackboneElement Ingredient Total per Batch
...... 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
...... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
....... presentationRatio Ratio
....... presentationRatioRange RatioRange
....... presentationCodeableConcept CodeableConcept
....... presentationQuantity Quantity
...... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
...... concentration[x] SΣ 1..1 Quantity The strength per unitary volume (or mass)
....... 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 Σ 0..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)
...... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
...... basis Σ 0..1 CodeableConcept A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes


...... referenceStrength Σ 0..* BackboneElement Strength expressed in terms of a reference substance
....... 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
....... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

....... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
........ strengthRatio Ratio
........ strengthRatioRange RatioRange
........ strengthQuantity Quantity
....... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
....... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes


..... strength:percent SΣ 1..1 BackboneElement Ingredient percent of Total Batch
...... 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
...... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
....... presentationRatio Ratio
....... presentationRatioRange RatioRange
....... presentationCodeableConcept CodeableConcept
....... presentationQuantity Quantity
...... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
...... concentration[x] SΣ 1..1 Quantity The strength per unitary volume (or mass)
....... 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 Σ 0..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)
...... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
...... basis Σ 0..1 CodeableConcept A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes


...... referenceStrength Σ 0..* BackboneElement Strength expressed in terms of a reference substance
....... 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
....... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

....... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
........ strengthRatio Ratio
........ strengthRatioRange RatioRange
........ strengthQuantity Quantity
....... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
....... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes



doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Ingredient.meta.securityextensibleAllSecurityLabels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
Ingredient.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
Ingredient.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Ingredient.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
Ingredient.roleexampleIngredientRole
http://hl7.org/fhir/ValueSet/ingredient-role
from the FHIR Standard
Ingredient.functionexampleIngredientFunction
http://hl7.org/fhir/ValueSet/ingredient-function
from the FHIR Standard
Ingredient.manufacturer.rolerequiredIngredientManufacturerRole
http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0
from the FHIR Standard
Ingredient.substance.codeexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
Ingredient.substance.strength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
Ingredient.substance.strength.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
Ingredient.substance.strength.referenceStrength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
from this IG
Ingredient.substance.strength:perBatch.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
Ingredient.substance.strength:perBatch.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
Ingredient.substance.strength:perBatch.referenceStrength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
from this IG
Ingredient.substance.strength:percent.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
Ingredient.substance.strength:percent.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
Ingredient.substance.strength:percent.referenceStrength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorIngredientIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorIngredientIf 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-4errorIngredientIf 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-5errorIngredientIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceIngredientA 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()
ing-1errorIngredientIf an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
: Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2

This structure is derived from Ingredient

Summary

Mandatory: 6 elements
Must-Support: 10 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Ingredient.substance.strength (Closed)

 

Other representations of profile: CSV, Excel, Schematron