Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry)
1.0.0 - STU1
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
| Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq | Version: 1.0.0 | |||
| Active as of 2024-05-08 | 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:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Substance
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  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 |
| 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 |
 identifier |
S | 0..* | Identifier | Unique identifier |
 status |
S | 0..1 | code | active | inactive | entered-in-error |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 | |
| 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. |
 code |
Σ | 1..1 | CodeableReference(SubstanceDefinition) | What substance this is Binding: SubstanceCode (example): Substance codes. |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Substance.status | required | FHIRSubstanceStatushttp://hl7.org/fhir/ValueSet/substance-status|5.0.0from the FHIR Standard | |
| Substance.code | example | SubstanceCodehttp://hl7.org/fhir/ValueSet/substance-codefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Substance | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Substance | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Substance | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Substance | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Substance | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| 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 | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| 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) | |||||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| Substance.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| Substance.status | required | FHIRSubstanceStatushttp://hl7.org/fhir/ValueSet/substance-status|5.0.0from the FHIR Standard | |
| Substance.category | extensible | SubstanceCategoryCodeshttp://hl7.org/fhir/ValueSet/substance-categoryfrom the FHIR Standard | |
| Substance.code | example | SubstanceCodehttp://hl7.org/fhir/ValueSet/substance-codefrom the FHIR Standard | |
| Substance.ingredient.substance[x] | example | SubstanceCodehttp://hl7.org/fhir/ValueSet/substance-codefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Substance | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Substance | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Substance | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Substance | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Substance | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Substance
Summary
Must-Support: 8 elements
Extensions
This structure refers to these extensions:
Differential View
This structure is derived from Substance
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 |
| 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 |
| identifier |
S | 0..* | Identifier | Unique identifier |
| status |
S | 0..1 | code | active | inactive | entered-in-error |
| Documentation for this format | ||||
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 | |
| 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. |
| code |
Σ | 1..1 | CodeableReference(SubstanceDefinition) | What substance this is Binding: SubstanceCode (example): Substance codes. |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Substance.status | required | FHIRSubstanceStatushttp://hl7.org/fhir/ValueSet/substance-status|5.0.0from the FHIR Standard | |
| Substance.code | example | SubstanceCodehttp://hl7.org/fhir/ValueSet/substance-codefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Substance | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Substance | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Substance | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Substance | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Substance | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| 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 | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| 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) | |||||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| Substance.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| Substance.status | required | FHIRSubstanceStatushttp://hl7.org/fhir/ValueSet/substance-status|5.0.0from the FHIR Standard | |
| Substance.category | extensible | SubstanceCategoryCodeshttp://hl7.org/fhir/ValueSet/substance-categoryfrom the FHIR Standard | |
| Substance.code | example | SubstanceCodehttp://hl7.org/fhir/ValueSet/substance-codefrom the FHIR Standard | |
| Substance.ingredient.substance[x] | example | SubstanceCodehttp://hl7.org/fhir/ValueSet/substance-codefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Substance | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Substance | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Substance | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Substance | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Substance | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Substance
Summary
Must-Support: 8 elements
Extensions
This structure refers to these extensions:
Other representations of profile: CSV, Excel, Schematron
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0. Generated 2024-05-08
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change