This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v2.0.0: STU2) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions
Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula | Version: 2.0.0 | |||
Standards status: Trial-use | Maturity Level: 2 | Computable Name: BatchFormula | ||
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.47 |
Listing of all components of the dosage form to be used in the manufacture, their amounts on a per batch basis, including overages, and reference to their quality standards.
Usages:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
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0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product | |
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?!Σ | 0..1 | uri | A set of rules under which this content was created |
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0..* | Resource | Contained, inline Resources | |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored |
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SΣ | 0..1 | Identifier | optional user designated identifier |
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?!SΣ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. |
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SΣ | 1..1 | string | Product Non-proprietary Name |
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Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required) |
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SΣ | 0..* | LiteralReference(Basic Organization) {b} | Manufacturer of the item, one of several possible |
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SΣ | 2..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type.text |
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Content/Rules for all slices | |||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
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SΣ | 1..1 | string | Plain text representation of the concept |
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SΣ | 1..1 | BackboneElement | Batch Quantity |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Quantity |
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SΣ | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (required) |
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) |
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
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ΣC | 0..1 | code | Quantity UOM |
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SΣ | 1..* | BackboneElement | Batch Utilization |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Utilization |
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SΣ | 1..1 | CodeableConcept | A value for the characteristic Binding: Batch utilization Terminology (required) |
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SΣ | 0..1 | BackboneElement | Batch Formula Additional Information |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Formula Additional Information |
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SΣ | 1..1 | markdown | A value for the characteristic |
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SΣ | 1..* | BackboneElement | Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | Product Part Type Binding: Product Part Type Terminology (required) |
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Σ | 2..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code |
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SΣ | 1..1 | Quantity | Component Quantity Per Batch |
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) |
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
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SΣ | 1..1 | string | Unit representation |
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SΣC | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
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SΣ | 1..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) |
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) |
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
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SΣ | 1..1 | string | Unit representation |
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SΣC | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) |
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SΣ | 1..* | BackboneElement | A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient) |
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0..* | Extension | Extension Slice: Unordered, Open by value:url | |
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S | 0..1 | markdown | Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension |
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SC | 0..1 | (Complex) | Overage Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension Constraints: cmc-overage-percent-limit |
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S | 0..1 | string | Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 2..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code |
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SΣ | 1..1 | Quantity | Component Quantity Per Batch |
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) |
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
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SΣ | 1..1 | string | Unit representation |
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SΣC | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
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SΣ | 1..1 | Quantity | Quantity Percent |
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) |
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
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SΣ | 1..1 | string | Unit representation |
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SΣC | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) |
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SΣ | 0..* | CodeableConcept | Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required) |
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SΣ | 1..1 | LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b} | The ingredient that is the constituent of the given component |
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SΣ | 1..* | BackboneElement | General characteristics of this component Slice: Unordered, Closed by value:type.text |
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Content/Rules for all slices | |||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
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SΣ | 1..1 | string | Plain text representation of the concept |
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SΣ | 1..1 | BackboneElement | Product Part Identifier |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier |
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SΣ | 1..1 | CodeableConceptTextOnly | A value for the characteristic |
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SΣ | 0..1 | BackboneElement | Product Part Identifier Reference |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier Reference |
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SΣ | 1..1 | CodeableConceptTextOnly | A value for the characteristic |
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SΣ | 0..1 | BackboneElement | Product Part Additional Information |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Additional Information |
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SΣ | 1..1 | markdown | A value for the characteristic |
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SΣ | 0..* | See component (ManufacturedItemDefinition) | A component that this component contains or is made from |
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Path | Conformance | ValueSet | URI |
ManufacturedItemDefinition.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.manufacturedDoseForm | required | PqcmcManufacturedDoseFormTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology From this IG | |
ManufacturedItemDefinition.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.property:BatchSize.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.property:BatchSize.value[x] | required | PqcmcUnitsMeasurehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure From this IG | |
ManufacturedItemDefinition.property:BatchSize.value[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.property:BatchUtil.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.property:BatchUtil.value[x] | required | PqcmcBatchUtilizationTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology From this IG | |
ManufacturedItemDefinition.property:AddInfo.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.component.type | required | PqcmcProductPartTypehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type From this IG | |
ManufacturedItemDefinition.component.amount:perBatch.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.component.amount:perBatch.code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG | |
ManufacturedItemDefinition.component.amount:percent.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.component.amount:percent.code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.amount:perBatch.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.component.constituent.amount:perBatch.code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.amount:percent.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.component.constituent.amount:percent.code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.location | required | PqcmcProductPartIngredientPhysicalLocationhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location From this IG | |
ManufacturedItemDefinition.component.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.component.property:PPiD.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.component.property:PPiDref.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.component.property:AddInfo.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
cmc-overage-percent-limit | error | ManufacturedItemDefinition.component.constituent.extension:ingredientOverage | Overage percent must be less than 1.0 : extension.where(url='proportionDecimal').single().value < 1 | |
dom-2 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | ManufacturedItemDefinition | 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 | ManufacturedItemDefinition | 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 | ManufacturedItemDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | ManufacturedItemDefinition | 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 ManufacturedItemDefinition
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
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ManufacturedItemDefinition | |||
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S | 0..1 | Identifier | optional user designated identifier |
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S | 1..1 | code | draft | active | retired | unknown |
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S | 1..1 | string | Product Non-proprietary Name |
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1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required) | |
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S | 0..* | LiteralReference(Basic Organization) {b} | Manufacturer of the item, one of several possible |
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S | 2..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type.text |
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Content/Rules for all slices | |||
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S | 1..1 | CodeableConcept | A code expressing the type of characteristic |
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S | 1..1 | string | Plain text representation of the concept |
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S | 1..1 | BackboneElement | Batch Quantity |
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1..1 | string | Plain text representation of the concept Required Pattern: Batch Quantity | |
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S | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (required) |
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S | 1..1 | decimal | Numerical value (with implicit precision) |
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0..1 | code | Quantity UOM | |
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S | 1..* | BackboneElement | Batch Utilization |
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1..1 | string | Plain text representation of the concept Required Pattern: Batch Utilization | |
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S | 1..1 | CodeableConcept | A value for the characteristic Binding: Batch utilization Terminology (required) |
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S | 0..1 | BackboneElement | Batch Formula Additional Information |
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1..1 | string | Plain text representation of the concept Required Pattern: Batch Formula Additional Information | |
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S | 1..1 | markdown | A value for the characteristic |
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S | 1..* | BackboneElement | Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup |
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S | 1..1 | CodeableConcept | Product Part Type Binding: Product Part Type Terminology (required) |
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2..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code | |
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S | 1..1 | Quantity | Component Quantity Per Batch |
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S | 1..1 | decimal | Numerical value (with implicit precision) |
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S | 1..1 | string | Unit representation |
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S | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
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S | 1..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) |
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S | 1..1 | decimal | Numerical value (with implicit precision) |
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S | 1..1 | string | Unit representation |
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S | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) |
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S | 1..* | BackboneElement | A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient) |
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0..* | Extension | Extension Slice: Unordered, Open by value:url | |
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S | 0..1 | markdown | Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension |
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S | 0..1 | (Complex) | Overage Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension |
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S | 0..1 | string | Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension |
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S | 2..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code |
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S | 1..1 | Quantity | Component Quantity Per Batch |
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S | 1..1 | decimal | Numerical value (with implicit precision) |
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S | 1..1 | string | Unit representation |
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S | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
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S | 1..1 | Quantity | Quantity Percent |
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S | 1..1 | decimal | Numerical value (with implicit precision) |
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S | 1..1 | string | Unit representation |
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S | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) |
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S | 0..* | CodeableConcept | Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required) |
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S | 1..1 | LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b} | The ingredient that is the constituent of the given component |
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S | 1..* | BackboneElement | General characteristics of this component Slice: Unordered, Closed by value:type.text |
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Content/Rules for all slices | |||
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S | 1..1 | CodeableConcept | A code expressing the type of characteristic |
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S | 1..1 | string | Plain text representation of the concept |
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S | 1..1 | BackboneElement | Product Part Identifier |
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1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier | |
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S | 1..1 | CodeableConceptTextOnly | A value for the characteristic |
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S | 0..1 | BackboneElement | Product Part Identifier Reference |
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1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier Reference | |
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S | 1..1 | CodeableConceptTextOnly | A value for the characteristic |
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S | 0..1 | BackboneElement | Product Part Additional Information |
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1..1 | string | Plain text representation of the concept Required Pattern: Product Part Additional Information | |
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S | 1..1 | markdown | A value for the characteristic |
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S | 0..* | A component that this component contains or is made from | |
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Path | Conformance | ValueSet | URI |
ManufacturedItemDefinition.manufacturedDoseForm | required | PqcmcManufacturedDoseFormTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology From this IG | |
ManufacturedItemDefinition.property:BatchSize.value[x] | required | PqcmcUnitsMeasurehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure From this IG | |
ManufacturedItemDefinition.property:BatchUtil.value[x] | required | PqcmcBatchUtilizationTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology From this IG | |
ManufacturedItemDefinition.component.type | required | PqcmcProductPartTypehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type From this IG | |
ManufacturedItemDefinition.component.amount:perBatch.code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG | |
ManufacturedItemDefinition.component.amount:percent.code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.amount:perBatch.code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.amount:percent.code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.location | required | PqcmcProductPartIngredientPhysicalLocationhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location From this IG |
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
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0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product | |||||
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Σ | 0..1 | id | Logical id of this artifact | ||||
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Σ | 0..1 | Meta | Metadata about the resource | ||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
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0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
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0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
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0..* | Resource | Contained, inline Resources | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
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SΣ | 0..1 | Identifier | optional user designated identifier | ||||
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?!SΣ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. | ||||
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SΣ | 1..1 | string | Product Non-proprietary Name | ||||
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Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required) | ||||
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Σ | 0..1 | CodeableConcept | The “real-world” units in which the quantity of the item is described Binding: UnitOfPresentation (example): The presentation type in which an administrable medicinal product is given to a patient. | ||||
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SΣ | 0..* | LiteralReference(Basic Organization) {b} | Manufacturer of the item, one of several possible | ||||
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Σ | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated | ||||
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Σ | 0..* | CodeableConcept | The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
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SΣ | 2..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type.text | ||||
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Content/Rules for all slices | |||||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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SΣ | 1..1 | string | Plain text representation of the concept | ||||
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Σ | 0..1 | A value for the characteristic | |||||
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CodeableConcept | |||||||
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Quantity | |||||||
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date | |||||||
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boolean | |||||||
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markdown | |||||||
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Attachment | |||||||
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Reference(Binary) | |||||||
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SΣ | 1..1 | BackboneElement | Batch Quantity | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Quantity | ||||
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SΣ | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (required) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) | ||||
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
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Σ | 0..1 | string | Unit representation | ||||
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ΣC | 0..1 | uri | System that defines coded unit form | ||||
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ΣC | 0..1 | code | Quantity UOM | ||||
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SΣ | 1..* | BackboneElement | Batch Utilization | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Utilization | ||||
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SΣ | 1..1 | CodeableConcept | A value for the characteristic Binding: Batch utilization Terminology (required) | ||||
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SΣ | 0..1 | BackboneElement | Batch Formula Additional Information | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Formula Additional Information | ||||
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SΣ | 1..1 | markdown | A value for the characteristic | ||||
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SΣ | 1..* | BackboneElement | Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | Product Part Type Binding: Product Part Type Terminology (required) | ||||
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Σ | 0..* | CodeableConcept | The function of this component within the item e.g. delivers active ingredient, masks taste | ||||
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Σ | 2..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code | ||||
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SΣ | 1..1 | Quantity | Component Quantity Per Batch | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) | ||||
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
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SΣ | 1..1 | string | Unit representation | ||||
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ΣC | 0..1 | uri | System that defines coded unit form | ||||
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SΣC | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) | ||||
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SΣ | 1..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) | ||||
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
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SΣ | 1..1 | string | Unit representation | ||||
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ΣC | 0..1 | uri | System that defines coded unit form | ||||
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SΣC | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) | ||||
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SΣ | 1..* | BackboneElement | A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient) | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
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S | 0..1 | markdown | Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension | ||||
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SC | 0..1 | (Complex) | Overage Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension Constraints: cmc-overage-percent-limit | ||||
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S | 0..1 | string | Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 2..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code | ||||
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SΣ | 1..1 | Quantity | Component Quantity Per Batch | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) | ||||
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
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SΣ | 1..1 | string | Unit representation | ||||
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ΣC | 0..1 | uri | System that defines coded unit form | ||||
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SΣC | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) | ||||
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SΣ | 1..1 | Quantity | Quantity Percent | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) | ||||
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
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SΣ | 1..1 | string | Unit representation | ||||
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ΣC | 0..1 | uri | System that defines coded unit form | ||||
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SΣC | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) | ||||
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SΣ | 0..* | CodeableConcept | Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required) | ||||
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Σ | 0..* | CodeableConcept | The function of this constituent within the component e.g. binder | ||||
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SΣ | 1..1 | LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b} | The ingredient that is the constituent of the given component | ||||
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SΣ | 1..* | BackboneElement | General characteristics of this component Slice: Unordered, Closed by value:type.text | ||||
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Content/Rules for all slices | |||||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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SΣ | 1..1 | string | Plain text representation of the concept | ||||
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Σ | 0..1 | A value for the characteristic | |||||
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CodeableConcept | |||||||
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Quantity | |||||||
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date | |||||||
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boolean | |||||||
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markdown | |||||||
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Attachment | |||||||
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Reference(Binary) | |||||||
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SΣ | 1..1 | BackboneElement | Product Part Identifier | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier | ||||
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SΣ | 1..1 | CodeableConceptTextOnly | A value for the characteristic | ||||
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SΣ | 0..1 | BackboneElement | Product Part Identifier Reference | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier Reference | ||||
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SΣ | 1..1 | CodeableConceptTextOnly | A value for the characteristic | ||||
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SΣ | 0..1 | BackboneElement | Product Part Additional Information | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Additional Information | ||||
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SΣ | 1..1 | markdown | A value for the characteristic | ||||
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SΣ | 0..* | See component (ManufacturedItemDefinition) | A component that this component contains or is made from | ||||
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Path | Conformance | ValueSet | URI |
ManufacturedItemDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.manufacturedDoseForm | required | PqcmcManufacturedDoseFormTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology From this IG | |
ManufacturedItemDefinition.unitOfPresentation | example | UnitOfPresentationhttp://hl7.org/fhir/ValueSet/unit-of-presentation From the FHIR Standard | |
ManufacturedItemDefinition.ingredient | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes From the FHIR Standard | |
ManufacturedItemDefinition.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.property:BatchSize.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.property:BatchSize.value[x] | required | PqcmcUnitsMeasurehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure From this IG | |
ManufacturedItemDefinition.property:BatchSize.value[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.property:BatchUtil.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.property:BatchUtil.value[x] | required | PqcmcBatchUtilizationTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology From this IG | |
ManufacturedItemDefinition.property:AddInfo.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.component.type | required | PqcmcProductPartTypehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type From this IG | |
ManufacturedItemDefinition.component.amount:perBatch.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.component.amount:perBatch.code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG | |
ManufacturedItemDefinition.component.amount:percent.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.component.amount:percent.code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.amount:perBatch.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.component.constituent.amount:perBatch.code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.amount:percent.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.component.constituent.amount:percent.code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.location | required | PqcmcProductPartIngredientPhysicalLocationhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location From this IG | |
ManufacturedItemDefinition.component.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.component.property:PPiD.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.component.property:PPiDref.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.component.property:AddInfo.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
cmc-overage-percent-limit | error | ManufacturedItemDefinition.component.constituent.extension:ingredientOverage | Overage percent must be less than 1.0 : extension.where(url='proportionDecimal').single().value < 1 | |
dom-2 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | ManufacturedItemDefinition | 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 | ManufacturedItemDefinition | 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 | ManufacturedItemDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | ManufacturedItemDefinition | 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 ManufacturedItemDefinition
Summary
Mandatory: 30 elements(3 nested mandatory elements)
Must-Support: 49 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
Slices
This structure defines the following Slices:
Maturity: 2
Key Elements View
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
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0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product | |
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?!Σ | 0..1 | uri | A set of rules under which this content was created |
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0..* | Resource | Contained, inline Resources | |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored |
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SΣ | 0..1 | Identifier | optional user designated identifier |
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?!SΣ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. |
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SΣ | 1..1 | string | Product Non-proprietary Name |
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Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required) |
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SΣ | 0..* | LiteralReference(Basic Organization) {b} | Manufacturer of the item, one of several possible |
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SΣ | 2..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type.text |
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Content/Rules for all slices | |||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
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SΣ | 1..1 | string | Plain text representation of the concept |
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SΣ | 1..1 | BackboneElement | Batch Quantity |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Quantity |
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SΣ | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (required) |
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) |
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
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ΣC | 0..1 | code | Quantity UOM |
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SΣ | 1..* | BackboneElement | Batch Utilization |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Utilization |
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SΣ | 1..1 | CodeableConcept | A value for the characteristic Binding: Batch utilization Terminology (required) |
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SΣ | 0..1 | BackboneElement | Batch Formula Additional Information |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Formula Additional Information |
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SΣ | 1..1 | markdown | A value for the characteristic |
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SΣ | 1..* | BackboneElement | Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | Product Part Type Binding: Product Part Type Terminology (required) |
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Σ | 2..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code |
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SΣ | 1..1 | Quantity | Component Quantity Per Batch |
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) |
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
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SΣ | 1..1 | string | Unit representation |
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SΣC | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
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SΣ | 1..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) |
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) |
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
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SΣ | 1..1 | string | Unit representation |
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SΣC | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) |
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SΣ | 1..* | BackboneElement | A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient) |
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0..* | Extension | Extension Slice: Unordered, Open by value:url | |
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S | 0..1 | markdown | Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension |
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SC | 0..1 | (Complex) | Overage Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension Constraints: cmc-overage-percent-limit |
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S | 0..1 | string | Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 2..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code |
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SΣ | 1..1 | Quantity | Component Quantity Per Batch |
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) |
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
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SΣ | 1..1 | string | Unit representation |
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SΣC | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
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SΣ | 1..1 | Quantity | Quantity Percent |
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) |
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
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SΣ | 1..1 | string | Unit representation |
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SΣC | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) |
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SΣ | 0..* | CodeableConcept | Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required) |
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SΣ | 1..1 | LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b} | The ingredient that is the constituent of the given component |
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SΣ | 1..* | BackboneElement | General characteristics of this component Slice: Unordered, Closed by value:type.text |
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Content/Rules for all slices | |||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
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SΣ | 1..1 | string | Plain text representation of the concept |
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SΣ | 1..1 | BackboneElement | Product Part Identifier |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier |
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SΣ | 1..1 | CodeableConceptTextOnly | A value for the characteristic |
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SΣ | 0..1 | BackboneElement | Product Part Identifier Reference |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier Reference |
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SΣ | 1..1 | CodeableConceptTextOnly | A value for the characteristic |
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SΣ | 0..1 | BackboneElement | Product Part Additional Information |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Additional Information |
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SΣ | 1..1 | markdown | A value for the characteristic |
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SΣ | 0..* | See component (ManufacturedItemDefinition) | A component that this component contains or is made from |
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Path | Conformance | ValueSet | URI |
ManufacturedItemDefinition.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.manufacturedDoseForm | required | PqcmcManufacturedDoseFormTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology From this IG | |
ManufacturedItemDefinition.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.property:BatchSize.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.property:BatchSize.value[x] | required | PqcmcUnitsMeasurehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure From this IG | |
ManufacturedItemDefinition.property:BatchSize.value[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.property:BatchUtil.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.property:BatchUtil.value[x] | required | PqcmcBatchUtilizationTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology From this IG | |
ManufacturedItemDefinition.property:AddInfo.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.component.type | required | PqcmcProductPartTypehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type From this IG | |
ManufacturedItemDefinition.component.amount:perBatch.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.component.amount:perBatch.code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG | |
ManufacturedItemDefinition.component.amount:percent.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.component.amount:percent.code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.amount:perBatch.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.component.constituent.amount:perBatch.code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.amount:percent.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.component.constituent.amount:percent.code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.location | required | PqcmcProductPartIngredientPhysicalLocationhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location From this IG | |
ManufacturedItemDefinition.component.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.component.property:PPiD.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.component.property:PPiDref.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.component.property:AddInfo.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
cmc-overage-percent-limit | error | ManufacturedItemDefinition.component.constituent.extension:ingredientOverage | Overage percent must be less than 1.0 : extension.where(url='proportionDecimal').single().value < 1 | |
dom-2 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | ManufacturedItemDefinition | 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 | ManufacturedItemDefinition | 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 | ManufacturedItemDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | ManufacturedItemDefinition | 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() |
Differential View
This structure is derived from ManufacturedItemDefinition
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
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ManufacturedItemDefinition | |||
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S | 0..1 | Identifier | optional user designated identifier |
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S | 1..1 | code | draft | active | retired | unknown |
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S | 1..1 | string | Product Non-proprietary Name |
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1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required) | |
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S | 0..* | LiteralReference(Basic Organization) {b} | Manufacturer of the item, one of several possible |
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S | 2..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type.text |
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Content/Rules for all slices | |||
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S | 1..1 | CodeableConcept | A code expressing the type of characteristic |
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S | 1..1 | string | Plain text representation of the concept |
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S | 1..1 | BackboneElement | Batch Quantity |
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||||
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1..1 | string | Plain text representation of the concept Required Pattern: Batch Quantity | |
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S | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (required) |
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S | 1..1 | decimal | Numerical value (with implicit precision) |
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0..1 | code | Quantity UOM | |
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S | 1..* | BackboneElement | Batch Utilization |
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1..1 | string | Plain text representation of the concept Required Pattern: Batch Utilization | |
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S | 1..1 | CodeableConcept | A value for the characteristic Binding: Batch utilization Terminology (required) |
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S | 0..1 | BackboneElement | Batch Formula Additional Information |
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1..1 | string | Plain text representation of the concept Required Pattern: Batch Formula Additional Information | |
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S | 1..1 | markdown | A value for the characteristic |
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S | 1..* | BackboneElement | Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup |
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S | 1..1 | CodeableConcept | Product Part Type Binding: Product Part Type Terminology (required) |
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2..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code | |
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S | 1..1 | Quantity | Component Quantity Per Batch |
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S | 1..1 | decimal | Numerical value (with implicit precision) |
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S | 1..1 | string | Unit representation |
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S | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
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S | 1..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) |
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S | 1..1 | decimal | Numerical value (with implicit precision) |
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S | 1..1 | string | Unit representation |
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S | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) |
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S | 1..* | BackboneElement | A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient) |
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0..* | Extension | Extension Slice: Unordered, Open by value:url | |
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S | 0..1 | markdown | Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension |
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S | 0..1 | (Complex) | Overage Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension |
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S | 0..1 | string | Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension |
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S | 2..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code |
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S | 1..1 | Quantity | Component Quantity Per Batch |
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S | 1..1 | decimal | Numerical value (with implicit precision) |
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S | 1..1 | string | Unit representation |
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S | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
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S | 1..1 | Quantity | Quantity Percent |
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S | 1..1 | decimal | Numerical value (with implicit precision) |
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S | 1..1 | string | Unit representation |
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S | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) |
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S | 0..* | CodeableConcept | Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required) |
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S | 1..1 | LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b} | The ingredient that is the constituent of the given component |
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S | 1..* | BackboneElement | General characteristics of this component Slice: Unordered, Closed by value:type.text |
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Content/Rules for all slices | |||
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S | 1..1 | CodeableConcept | A code expressing the type of characteristic |
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S | 1..1 | string | Plain text representation of the concept |
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S | 1..1 | BackboneElement | Product Part Identifier |
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1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier | |
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S | 1..1 | CodeableConceptTextOnly | A value for the characteristic |
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S | 0..1 | BackboneElement | Product Part Identifier Reference |
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1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier Reference | |
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S | 1..1 | CodeableConceptTextOnly | A value for the characteristic |
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S | 0..1 | BackboneElement | Product Part Additional Information |
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1..1 | string | Plain text representation of the concept Required Pattern: Product Part Additional Information | |
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S | 1..1 | markdown | A value for the characteristic |
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S | 0..* | A component that this component contains or is made from | |
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Path | Conformance | ValueSet | URI |
ManufacturedItemDefinition.manufacturedDoseForm | required | PqcmcManufacturedDoseFormTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology From this IG | |
ManufacturedItemDefinition.property:BatchSize.value[x] | required | PqcmcUnitsMeasurehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure From this IG | |
ManufacturedItemDefinition.property:BatchUtil.value[x] | required | PqcmcBatchUtilizationTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology From this IG | |
ManufacturedItemDefinition.component.type | required | PqcmcProductPartTypehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type From this IG | |
ManufacturedItemDefinition.component.amount:perBatch.code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG | |
ManufacturedItemDefinition.component.amount:percent.code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.amount:perBatch.code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.amount:percent.code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.location | required | PqcmcProductPartIngredientPhysicalLocationhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location From this IG |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
---|---|---|---|---|---|---|---|---|
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0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product | |||||
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Σ | 0..1 | id | Logical id of this artifact | ||||
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Σ | 0..1 | Meta | Metadata about the resource | ||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
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0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
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0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
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0..* | Resource | Contained, inline Resources | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
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SΣ | 0..1 | Identifier | optional user designated identifier | ||||
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?!SΣ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. | ||||
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SΣ | 1..1 | string | Product Non-proprietary Name | ||||
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Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required) | ||||
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Σ | 0..1 | CodeableConcept | The “real-world” units in which the quantity of the item is described Binding: UnitOfPresentation (example): The presentation type in which an administrable medicinal product is given to a patient. | ||||
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SΣ | 0..* | LiteralReference(Basic Organization) {b} | Manufacturer of the item, one of several possible | ||||
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Σ | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated | ||||
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Σ | 0..* | CodeableConcept | The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
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SΣ | 2..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type.text | ||||
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Content/Rules for all slices | |||||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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SΣ | 1..1 | string | Plain text representation of the concept | ||||
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Σ | 0..1 | A value for the characteristic | |||||
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CodeableConcept | |||||||
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Quantity | |||||||
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date | |||||||
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boolean | |||||||
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markdown | |||||||
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Attachment | |||||||
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Reference(Binary) | |||||||
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SΣ | 1..1 | BackboneElement | Batch Quantity | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Quantity | ||||
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SΣ | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (required) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) | ||||
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
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Σ | 0..1 | string | Unit representation | ||||
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ΣC | 0..1 | uri | System that defines coded unit form | ||||
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ΣC | 0..1 | code | Quantity UOM | ||||
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SΣ | 1..* | BackboneElement | Batch Utilization | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Utilization | ||||
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SΣ | 1..1 | CodeableConcept | A value for the characteristic Binding: Batch utilization Terminology (required) | ||||
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SΣ | 0..1 | BackboneElement | Batch Formula Additional Information | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Formula Additional Information | ||||
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SΣ | 1..1 | markdown | A value for the characteristic | ||||
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SΣ | 1..* | BackboneElement | Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | Product Part Type Binding: Product Part Type Terminology (required) | ||||
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Σ | 0..* | CodeableConcept | The function of this component within the item e.g. delivers active ingredient, masks taste | ||||
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Σ | 2..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code | ||||
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SΣ | 1..1 | Quantity | Component Quantity Per Batch | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) | ||||
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
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SΣ | 1..1 | string | Unit representation | ||||
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ΣC | 0..1 | uri | System that defines coded unit form | ||||
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SΣC | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) | ||||
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SΣ | 1..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) | ||||
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
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SΣ | 1..1 | string | Unit representation | ||||
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ΣC | 0..1 | uri | System that defines coded unit form | ||||
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SΣC | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) | ||||
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SΣ | 1..* | BackboneElement | A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient) | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
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S | 0..1 | markdown | Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension | ||||
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SC | 0..1 | (Complex) | Overage Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension Constraints: cmc-overage-percent-limit | ||||
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S | 0..1 | string | Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 2..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code | ||||
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SΣ | 1..1 | Quantity | Component Quantity Per Batch | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) | ||||
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
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SΣ | 1..1 | string | Unit representation | ||||
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ΣC | 0..1 | uri | System that defines coded unit form | ||||
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SΣC | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) | ||||
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SΣ | 1..1 | Quantity | Quantity Percent | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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SΣ | 1..1 | decimal | Numerical value (with implicit precision) | ||||
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?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
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SΣ | 1..1 | string | Unit representation | ||||
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ΣC | 0..1 | uri | System that defines coded unit form | ||||
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SΣC | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) | ||||
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SΣ | 0..* | CodeableConcept | Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required) | ||||
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Σ | 0..* | CodeableConcept | The function of this constituent within the component e.g. binder | ||||
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SΣ | 1..1 | LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b} | The ingredient that is the constituent of the given component | ||||
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SΣ | 1..* | BackboneElement | General characteristics of this component Slice: Unordered, Closed by value:type.text | ||||
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Content/Rules for all slices | |||||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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SΣ | 1..1 | string | Plain text representation of the concept | ||||
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Σ | 0..1 | A value for the characteristic | |||||
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CodeableConcept | |||||||
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Quantity | |||||||
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date | |||||||
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boolean | |||||||
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markdown | |||||||
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Attachment | |||||||
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Reference(Binary) | |||||||
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SΣ | 1..1 | BackboneElement | Product Part Identifier | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier | ||||
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SΣ | 1..1 | CodeableConceptTextOnly | A value for the characteristic | ||||
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SΣ | 0..1 | BackboneElement | Product Part Identifier Reference | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier Reference | ||||
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SΣ | 1..1 | CodeableConceptTextOnly | A value for the characteristic | ||||
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SΣ | 0..1 | BackboneElement | Product Part Additional Information | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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SΣ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Additional Information | ||||
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SΣ | 1..1 | markdown | A value for the characteristic | ||||
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SΣ | 0..* | See component (ManufacturedItemDefinition) | A component that this component contains or is made from | ||||
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Path | Conformance | ValueSet | URI |
ManufacturedItemDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.manufacturedDoseForm | required | PqcmcManufacturedDoseFormTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology From this IG | |
ManufacturedItemDefinition.unitOfPresentation | example | UnitOfPresentationhttp://hl7.org/fhir/ValueSet/unit-of-presentation From the FHIR Standard | |
ManufacturedItemDefinition.ingredient | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes From the FHIR Standard | |
ManufacturedItemDefinition.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.property:BatchSize.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.property:BatchSize.value[x] | required | PqcmcUnitsMeasurehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure From this IG | |
ManufacturedItemDefinition.property:BatchSize.value[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.property:BatchUtil.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.property:BatchUtil.value[x] | required | PqcmcBatchUtilizationTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology From this IG | |
ManufacturedItemDefinition.property:AddInfo.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.component.type | required | PqcmcProductPartTypehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type From this IG | |
ManufacturedItemDefinition.component.amount:perBatch.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.component.amount:perBatch.code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG | |
ManufacturedItemDefinition.component.amount:percent.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.component.amount:percent.code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.amount:perBatch.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.component.constituent.amount:perBatch.code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.amount:percent.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard | |
ManufacturedItemDefinition.component.constituent.amount:percent.code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG | |
ManufacturedItemDefinition.component.constituent.location | required | PqcmcProductPartIngredientPhysicalLocationhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location From this IG | |
ManufacturedItemDefinition.component.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.component.property:PPiD.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.component.property:PPiDref.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard | |
ManufacturedItemDefinition.component.property:AddInfo.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
cmc-overage-percent-limit | error | ManufacturedItemDefinition.component.constituent.extension:ingredientOverage | Overage percent must be less than 1.0 : extension.where(url='proportionDecimal').single().value < 1 | |
dom-2 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | ManufacturedItemDefinition | 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 | ManufacturedItemDefinition | 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 | ManufacturedItemDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | ManufacturedItemDefinition | 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 ManufacturedItemDefinition
Summary
Mandatory: 30 elements(3 nested mandatory elements)
Must-Support: 49 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
Slices
This structure defines the following Slices:
Maturity: 2
Other representations of profile: CSV, Excel, Schematron