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

## Resource Profile: Substance - Drug

Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq | Version: 1.0.0
Active as of 2024-05-08 | 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:

- Use this Resource Profile: Bundle – Batch Analysis PQ, Bundle – Drug Reference Standards PQ, Bundle – Drug Stability PQ, Bundle – Drug Substance Batch Information PQ... Show 2 more, Bundle – Drug Substance Characterization PQ and Bundle - Product Process Validation PQ
- Refer to this Resource Profile: Extension - Batch Substance Batch PQ
- Examples for this Resource Profile: Substance/substance-drug-pq-ex1

### Formal Views of Profile Content

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

- Differential Table
- Key Elements Table
- Snapshot Table
- Statistics/References
- All

This structure is derived from 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 | S Σ | 0..* | Identifier | Unique identifier
instance | ?!Σ | 1..1 | boolean | Is this an instance of a substance or a kind of one
status | ?!S Σ | 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

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Substance.status | required | FHIRSubstanceStatus `http://hl7.org/fhir/ValueSet/substance-status|5.0.0` from the FHIR Standard
Substance.code | example | SubstanceCode `http://hl7.org/fhir/ValueSet/substance-code` from the FHIR Standard

#### Constraints

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
Additional Bindings | Purpose
CommonLanguages | Starter Set
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 | S Σ | 0..* | Identifier | Unique identifier
instance | ?!Σ | 1..1 | boolean | Is this an instance of a substance or a kind of one
status | ?!S Σ | 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

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Substance.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` from the FHIR Standard
Substance.status | required | FHIRSubstanceStatus `http://hl7.org/fhir/ValueSet/substance-status|5.0.0` from the FHIR Standard
Substance.category | extensible | SubstanceCategoryCodes `http://hl7.org/fhir/ValueSet/substance-category` from the FHIR Standard
Substance.code | example | SubstanceCode `http://hl7.org/fhir/ValueSet/substance-code` from the FHIR Standard
Substance.ingredient.substance[x] | example | SubstanceCode `http://hl7.org/fhir/ValueSet/substance-code` from the FHIR Standard

#### Constraints

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:

- http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-process-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq

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 | S Σ | 0..* | Identifier | Unique identifier
instance | ?!Σ | 1..1 | boolean | Is this an instance of a substance or a kind of one
status | ?!S Σ | 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

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Substance.status | required | FHIRSubstanceStatus `http://hl7.org/fhir/ValueSet/substance-status|5.0.0` from the FHIR Standard
Substance.code | example | SubstanceCode `http://hl7.org/fhir/ValueSet/substance-code` from the FHIR Standard

#### Constraints

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
Additional Bindings | Purpose
CommonLanguages | Starter Set
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 | S Σ | 0..* | Identifier | Unique identifier
instance | ?!Σ | 1..1 | boolean | Is this an instance of a substance or a kind of one
status | ?!S Σ | 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

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Substance.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` from the FHIR Standard
Substance.status | required | FHIRSubstanceStatus `http://hl7.org/fhir/ValueSet/substance-status|5.0.0` from the FHIR Standard
Substance.category | extensible | SubstanceCategoryCodes `http://hl7.org/fhir/ValueSet/substance-category` from the FHIR Standard
Substance.code | example | SubstanceCode `http://hl7.org/fhir/ValueSet/substance-code` from the FHIR Standard
Substance.ingredient.substance[x] | example | SubstanceCode `http://hl7.org/fhir/ValueSet/substance-code` from the FHIR Standard

#### Constraints

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:

- http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-process-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq

Other representations of profile: CSV, Excel, Schematron