Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Resource Profile: Substance - Drug

Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq Version: 1.0.0
Active as of 2024-04-22 Computable Name: SubstanceDrugPq
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.39

This Substance profile represents identifying information about an actual batch of substance (an instance).

Usage:

Formal Views of Profile Content

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

This structure is derived from Substance

NameFlagsCard.TypeDescription & Constraintsdoco
.. Substance 0..* Substance A homogeneous material with a definite composition
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... medication-manufacturingBatch S 0..1 (Complex) medication-manufacturingBatch
URL: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
... batch-release-date S 0..* dateTime batch-release-date
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq
... manufacturing-process S 0..* Reference(PlanDefinition - Drug PQ) manufacturing-process
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-process-pq
... actual-yield S 0..* Quantity actual-yield
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq
... batch-derived-from S 0..* Reference() batch-derived-from
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq
... identifier S 0..* Identifier Unique identifier
... status S 0..1 code active | inactive | entered-in-error

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Substance 0..* Substance A homogeneous material with a definite composition
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... batch-release-date S 0..* dateTime batch-release-date
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq
... batch-retest-date S 0..* dateTime batch-retest-date
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq
... manufacturing-process S 0..* Reference(PlanDefinition - Drug PQ) manufacturing-process
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-process-pq
... actual-yield S 0..* Quantity actual-yield
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq
... batch-derived-from S 0..* Reference() batch-derived-from
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..* Identifier Unique identifier
... instance ?!Σ 1..1 boolean Is this an instance of a substance or a kind of one
... status ?!SΣ 0..1 code active | inactive | entered-in-error
Binding: FHIRSubstanceStatus (required): A code to indicate if the substance is actively used.

... code Σ 1..1 CodeableReference(SubstanceDefinition) What substance this is
Binding: SubstanceCode (example): Substance codes.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Substance.statusrequiredFHIRSubstanceStatus
http://hl7.org/fhir/ValueSet/substance-status|5.0.0
from the FHIR Standard
Substance.codeexampleSubstanceCode
http://hl7.org/fhir/ValueSet/substance-code
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorSubstanceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceIf 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-4errorSubstanceIf 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-5errorSubstanceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceA 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
.. Substance 0..* Substance A homogeneous material with a definite composition
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... medication-manufacturingBatch S 0..1 (Complex) medication-manufacturingBatch
URL: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
... batch-release-date S 0..* dateTime batch-release-date
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq
... batch-retest-date S 0..* dateTime batch-retest-date
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq
... manufacturing-process S 0..* Reference(PlanDefinition - Drug PQ) manufacturing-process
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-process-pq
... actual-yield S 0..* Quantity actual-yield
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq
... batch-derived-from S 0..* Reference() batch-derived-from
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..* Identifier Unique identifier
... instance ?!Σ 1..1 boolean Is this an instance of a substance or a kind of one
... status ?!SΣ 0..1 code active | inactive | entered-in-error
Binding: FHIRSubstanceStatus (required): A code to indicate if the substance is actively used.

... category Σ 0..* CodeableConcept What class/type of substance this is
Binding: SubstanceCategoryCodes (extensible): Category or classification of substance.


... code Σ 1..1 CodeableReference(SubstanceDefinition) What substance this is
Binding: SubstanceCode (example): Substance codes.

... description Σ 0..1 markdown Textual description of the substance, comments
... expiry Σ 0..1 dateTime When no longer valid to use
... quantity Σ 0..1 SimpleQuantity Amount of substance in the package
... ingredient Σ 0..* BackboneElement Composition information about the 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
.... quantity Σ 0..1 Ratio Optional amount (concentration)
.... substance[x] Σ 1..1 A component of the substance
Binding: SubstanceCode (example): Substance Ingredient codes.

..... substanceCodeableConcept CodeableConcept
..... substanceReference Reference(Substance)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Substance.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Substance.statusrequiredFHIRSubstanceStatus
http://hl7.org/fhir/ValueSet/substance-status|5.0.0
from the FHIR Standard
Substance.categoryextensibleSubstanceCategoryCodes
http://hl7.org/fhir/ValueSet/substance-category
from the FHIR Standard
Substance.codeexampleSubstanceCode
http://hl7.org/fhir/ValueSet/substance-code
from the FHIR Standard
Substance.ingredient.substance[x]exampleSubstanceCode
http://hl7.org/fhir/ValueSet/substance-code
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorSubstanceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceIf 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-4errorSubstanceIf 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-5errorSubstanceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceA 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()

Differential View

This structure is derived from Substance

NameFlagsCard.TypeDescription & Constraintsdoco
.. Substance 0..* Substance A homogeneous material with a definite composition
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... medication-manufacturingBatch S 0..1 (Complex) medication-manufacturingBatch
URL: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
... batch-release-date S 0..* dateTime batch-release-date
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq
... manufacturing-process S 0..* Reference(PlanDefinition - Drug PQ) manufacturing-process
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-process-pq
... actual-yield S 0..* Quantity actual-yield
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq
... batch-derived-from S 0..* Reference() batch-derived-from
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq
... identifier S 0..* Identifier Unique identifier
... status S 0..1 code active | inactive | entered-in-error

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Substance 0..* Substance A homogeneous material with a definite composition
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... batch-release-date S 0..* dateTime batch-release-date
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq
... batch-retest-date S 0..* dateTime batch-retest-date
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq
... manufacturing-process S 0..* Reference(PlanDefinition - Drug PQ) manufacturing-process
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-process-pq
... actual-yield S 0..* Quantity actual-yield
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq
... batch-derived-from S 0..* Reference() batch-derived-from
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..* Identifier Unique identifier
... instance ?!Σ 1..1 boolean Is this an instance of a substance or a kind of one
... status ?!SΣ 0..1 code active | inactive | entered-in-error
Binding: FHIRSubstanceStatus (required): A code to indicate if the substance is actively used.

... code Σ 1..1 CodeableReference(SubstanceDefinition) What substance this is
Binding: SubstanceCode (example): Substance codes.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Substance.statusrequiredFHIRSubstanceStatus
http://hl7.org/fhir/ValueSet/substance-status|5.0.0
from the FHIR Standard
Substance.codeexampleSubstanceCode
http://hl7.org/fhir/ValueSet/substance-code
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorSubstanceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceIf 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-4errorSubstanceIf 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-5errorSubstanceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceA 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()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Substance 0..* Substance A homogeneous material with a definite composition
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... medication-manufacturingBatch S 0..1 (Complex) medication-manufacturingBatch
URL: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
... batch-release-date S 0..* dateTime batch-release-date
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq
... batch-retest-date S 0..* dateTime batch-retest-date
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq
... manufacturing-process S 0..* Reference(PlanDefinition - Drug PQ) manufacturing-process
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-process-pq
... actual-yield S 0..* Quantity actual-yield
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq
... batch-derived-from S 0..* Reference() batch-derived-from
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..* Identifier Unique identifier
... instance ?!Σ 1..1 boolean Is this an instance of a substance or a kind of one
... status ?!SΣ 0..1 code active | inactive | entered-in-error
Binding: FHIRSubstanceStatus (required): A code to indicate if the substance is actively used.

... category Σ 0..* CodeableConcept What class/type of substance this is
Binding: SubstanceCategoryCodes (extensible): Category or classification of substance.


... code Σ 1..1 CodeableReference(SubstanceDefinition) What substance this is
Binding: SubstanceCode (example): Substance codes.

... description Σ 0..1 markdown Textual description of the substance, comments
... expiry Σ 0..1 dateTime When no longer valid to use
... quantity Σ 0..1 SimpleQuantity Amount of substance in the package
... ingredient Σ 0..* BackboneElement Composition information about the 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
.... quantity Σ 0..1 Ratio Optional amount (concentration)
.... substance[x] Σ 1..1 A component of the substance
Binding: SubstanceCode (example): Substance Ingredient codes.

..... substanceCodeableConcept CodeableConcept
..... substanceReference Reference(Substance)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Substance.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Substance.statusrequiredFHIRSubstanceStatus
http://hl7.org/fhir/ValueSet/substance-status|5.0.0
from the FHIR Standard
Substance.categoryextensibleSubstanceCategoryCodes
http://hl7.org/fhir/ValueSet/substance-category
from the FHIR Standard
Substance.codeexampleSubstanceCode
http://hl7.org/fhir/ValueSet/substance-code
from the FHIR Standard
Substance.ingredient.substance[x]exampleSubstanceCode
http://hl7.org/fhir/ValueSet/substance-code
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorSubstanceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceIf 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-4errorSubstanceIf 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-5errorSubstanceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceA 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()

 

Other representations of profile: CSV, Excel, Schematron