Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.6 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula | Version: 1.1.6 | |||
Active as of 2024-09-22 | 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.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ManufacturedItemDefinition
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
ManufacturedItemDefinition | ManufacturedItemDefinition | |||
meta | ||||
profile | S | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
identifier | S | 0..1 | Identifier | optional user designated identifier |
status | S | 1..1 | code | draft | active | retired | unknown |
name | S | 1..1 | string | Product Non-proprietary Name |
manufacturedDoseForm | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required) | |
manufacturer | S | 0..* | Reference(Basic Organization) | Manufacturer of the item, one of several possible |
Slices for property | S | 2..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type |
property:BatchSize | S | 1..1 | BackboneElement | General characteristics of this item |
type | S | 1..1 | CodeableConcept | Batch Quantity Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: batchsize | |
display | 1..1 | string | Representation defined by the system Fixed Value: Batch Quantity | |
value[x] | 0..1 | Quantity | A value for the characteristic | |
unit | S | 1..1 | string | Quantity UOM |
code | S | 1..1 | code | Coded form of the unit Binding: Units Of Measure (required) |
property:BatchUtil | S | 1..* | BackboneElement | General characteristics of this item |
type | 1..1 | CodeableConcept | A code expressing the type of characteristic Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: BatchUtil | |
display | 1..1 | string | Representation defined by the system Fixed Value: Batch Utilization | |
value[x] | S | 1..1 | CodeableConcept | Batch Utilization |
coding | 0..* | Coding | Code defined by a terminology system Binding: Batch utilization Terminology (required) | |
property:AddInfo | S | 0..1 | BackboneElement | General characteristics of this item |
type | S | 1..1 | CodeableConcept | Batch Formula Additional Information Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: AddInfo | |
display | 1..1 | string | Representation defined by the system Fixed Value: Product Part Additional Information | |
value[x] | 0..1 | markdown | A value for the characteristic | |
component | 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 |
type | S | 1..1 | CodeableConcept | Product Part Type Binding: Product Part Type Terminology (required) |
Slices for amount | 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 | |
amount:perBatch | S | 1..1 | Quantity | Component Quantity Per Batch |
value | S | 1..1 | decimal | Numerical value (with implicit precision) |
unit | S | 1..1 | string | Unit representation |
code | S | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
amount:percent | 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) |
value | S | 1..1 | decimal | Numerical value (with implicit precision) |
unit | S | 1..1 | string | Unit representation |
code | S | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) |
constituent | 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) |
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
additional-info | S | 0..1 | markdown | Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension |
formulaIngredient | S | 0..1 | (Complex) | Product Batch Ingredient Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension |
Slices for amount | 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 |
amount:perBatch | S | 1..1 | Quantity | Component Quantity Per Batch |
value | S | 1..1 | decimal | Numerical value (with implicit precision) |
unit | S | 1..1 | string | Unit representation |
code | S | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
amount:percent | S | 1..1 | Quantity | Quantity Percent |
value | S | 1..1 | decimal | Numerical value (with implicit precision) |
unit | S | 1..1 | string | Unit representation |
code | S | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) |
location | S | 0..* | CodeableConcept | Product Part Ingredient Physical Location |
coding | 0..* | Coding | Code defined by a terminology system Binding: Ingredient Location Terminology (required) | |
hasIngredient | S | 1..1 | CodeableReference(Drug Product Batch Formula Ingredient) | The ingredient that is the constituent of the given component |
Slices for property | S | 1..3 | General characteristics of this component Slice: Unordered, Closed by value:type | |
property:PPiD | S | 1..1 | BackboneElement | General characteristics of this component |
type | S | 1..1 | CodeableConcept | A code expressing the type of characteristic Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: PPiD | |
display | 1..1 | string | Representation defined by the system Fixed Value: Product Part Identifier | |
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic |
text | S | 1..1 | string | Product Part Identifier |
property:PPiDref | S | 0..1 | BackboneElement | General characteristics of this component |
type | S | 1..1 | CodeableConcept | A code expressing the type of characteristic Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: PPiDref | |
display | 1..1 | string | Representation defined by the system Fixed Value: Product Part Identifier Reference | |
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic |
text | S | 1..1 | string | Product Part Identifier Reference |
property:AddInfo | S | 0..1 | BackboneElement | General characteristics of this component |
type | S | 1..1 | CodeableConcept | Batch Component Additional Information Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: AddInfo | |
display | 1..1 | string | Representation defined by the system Fixed Value: Product Part Additional Information | |
value[x] | 0..1 | markdown | A value for the characteristic | |
Documentation for this format |
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].code | required | PqcmcUnitsMeasurehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG | |
ManufacturedItemDefinition.property:BatchUtil.value[x].coding | 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.coding | 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 |
---|---|---|---|---|
ManufacturedItemDefinition | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product | |
meta | Σ | 0..1 | Meta | Metadata about the resource |
profile | SΣ | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
contained | 0..* | Resource | Contained, inline Resources | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
identifier | SΣ | 0..1 | Identifier | optional user designated identifier |
status | ?!SΣ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. |
name | SΣ | 1..1 | string | Product Non-proprietary Name |
manufacturedDoseForm | Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required) |
manufacturer | SΣ | 0..* | Reference(Basic Organization) | Manufacturer of the item, one of several possible |
Slices for property | SΣ | 2..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type |
property:All Slices | Content/Rules for all slices | |||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
type | Σ | 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. |
property:BatchSize | SΣ | 1..1 | BackboneElement | General characteristics of this item |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
type | SΣ | 1..1 | CodeableConcept | Batch Quantity Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: batchsize | |
display | 1..1 | string | Representation defined by the system Fixed Value: Batch Quantity | |
value[x] | Σ | 0..1 | Quantity | A value for the characteristic |
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
unit | SΣ | 1..1 | string | Quantity UOM |
code | SΣC | 1..1 | code | Coded form of the unit Binding: Units Of Measure (required) |
property:BatchUtil | SΣ | 1..* | BackboneElement | General characteristics of this item |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
type | Σ | 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. Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: BatchUtil | |
display | 1..1 | string | Representation defined by the system Fixed Value: Batch Utilization | |
value[x] | SΣ | 1..1 | CodeableConcept | Batch Utilization |
coding | Σ | 0..* | Coding | Code defined by a terminology system Binding: Batch utilization Terminology (required) |
property:AddInfo | SΣ | 0..1 | BackboneElement | General characteristics of this item |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
type | SΣ | 1..1 | CodeableConcept | Batch Formula Additional Information Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: AddInfo | |
display | 1..1 | string | Representation defined by the system Fixed Value: Product Part Additional Information | |
value[x] | Σ | 0..1 | markdown | A value for the characteristic |
component | 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 |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
type | SΣ | 1..1 | CodeableConcept | Product Part Type Binding: Product Part Type Terminology (required) |
Slices for amount | 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 |
amount:perBatch | SΣ | 1..1 | Quantity | Component Quantity Per Batch |
value | SΣ | 1..1 | decimal | Numerical value (with implicit precision) |
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
unit | SΣ | 1..1 | string | Unit representation |
code | SΣC | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
amount:percent | 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) |
value | SΣ | 1..1 | decimal | Numerical value (with implicit precision) |
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
unit | SΣ | 1..1 | string | Unit representation |
code | SΣC | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) |
constituent | 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) |
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
additional-info | S | 0..1 | markdown | Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension |
formulaIngredient | S | 0..1 | (Complex) | Product Batch Ingredient Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
Slices for amount | 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 |
amount:perBatch | SΣ | 1..1 | Quantity | Component Quantity Per Batch |
value | SΣ | 1..1 | decimal | Numerical value (with implicit precision) |
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
unit | SΣ | 1..1 | string | Unit representation |
code | SΣC | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
amount:percent | SΣ | 1..1 | Quantity | Quantity Percent |
value | SΣ | 1..1 | decimal | Numerical value (with implicit precision) |
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
unit | SΣ | 1..1 | string | Unit representation |
code | SΣC | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) |
location | SΣ | 0..* | CodeableConcept | Product Part Ingredient Physical Location |
coding | Σ | 0..* | Coding | Code defined by a terminology system Binding: Ingredient Location Terminology (required) |
hasIngredient | SΣ | 1..1 | CodeableReference(Drug Product Batch Formula Ingredient) | The ingredient that is the constituent of the given component |
Slices for property | SΣ | 1..3 | See property (ManufacturedItemDefinition) | General characteristics of this component Slice: Unordered, Closed by value:type |
property:PPiD | SΣ | 1..1 | BackboneElement | General characteristics of this component |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
type | 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. Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: PPiD | |
display | 1..1 | string | Representation defined by the system Fixed Value: Product Part Identifier | |
value[x] | SΣ | 1..1 | CodeableConcept | A value for the characteristic |
text | SΣ | 1..1 | string | Product Part Identifier |
property:PPiDref | SΣ | 0..1 | BackboneElement | General characteristics of this component |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
type | 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. Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: PPiDref | |
display | 1..1 | string | Representation defined by the system Fixed Value: Product Part Identifier Reference | |
value[x] | SΣ | 1..1 | CodeableConcept | A value for the characteristic |
text | SΣ | 1..1 | string | Product Part Identifier Reference |
property:AddInfo | SΣ | 0..1 | BackboneElement | General characteristics of this component |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
type | SΣ | 1..1 | CodeableConcept | Batch Component Additional Information Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: AddInfo | |
display | 1..1 | string | Representation defined by the system Fixed Value: Product Part Additional Information | |
value[x] | Σ | 0..1 | markdown | A value for the characteristic |
Documentation for this format |
Path | Conformance | ValueSet / Code | 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 | Pattern: batchsize("Batch Quantity")http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard | |
ManufacturedItemDefinition.property:BatchSize.value[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard | |
ManufacturedItemDefinition.property:BatchSize.value[x].code | required | PqcmcUnitsMeasurehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG | |
ManufacturedItemDefinition.property:BatchUtil.type | example | Pattern: BatchUtil("Batch Utilization")http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard | |
ManufacturedItemDefinition.property:BatchUtil.value[x].coding | required | PqcmcBatchUtilizationTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology from this IG | |
ManufacturedItemDefinition.property:AddInfo.type | example | Pattern: AddInfo("Product Part Additional Information")http://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.coding | required | PqcmcProductPartIngredientPhysicalLocationhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG | |
ManufacturedItemDefinition.component.property:PPiD.type | example | Pattern: PPiD("Product Part Identifier")http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard | |
ManufacturedItemDefinition.component.property:PPiDref.type | example | Pattern: PPiDref("Product Part Identifier Reference")http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard | |
ManufacturedItemDefinition.component.property:AddInfo.type | example | Pattern: AddInfo("Product Part Additional Information")http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
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() |
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
ManufacturedItemDefinition | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product | |||||
id | Σ | 0..1 | id | Logical id of this artifact | ||||
meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
versionId | Σ | 0..1 | id | Version specific identifier | ||||
lastUpdated | Σ | 0..1 | instant | When the resource version last changed | ||||
source | Σ | 0..1 | uri | Identifies where the resource comes from | ||||
profile | SΣ | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to | ||||
security | Σ | 0..* | Coding | Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System. | ||||
tag | Σ | 0..* | Coding | Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". | ||||
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
contained | 0..* | Resource | Contained, inline Resources | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
identifier | SΣ | 0..1 | Identifier | optional user designated identifier | ||||
status | ?!SΣ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. | ||||
name | SΣ | 1..1 | string | Product Non-proprietary Name | ||||
manufacturedDoseForm | Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required) | ||||
unitOfPresentation | 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. | ||||
manufacturer | SΣ | 0..* | Reference(Basic Organization) | Manufacturer of the item, one of several possible | ||||
marketingStatus | 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 | ||||
ingredient | 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. | ||||
Slices for property | SΣ | 2..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type | ||||
property:All Slices | Content/Rules for all slices | |||||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | Σ | 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. | ||||
value[x] | Σ | 0..1 | A value for the characteristic | |||||
valueCodeableConcept | CodeableConcept | |||||||
valueQuantity | Quantity | |||||||
valueDate | date | |||||||
valueBoolean | boolean | |||||||
valueMarkdown | markdown | |||||||
valueAttachment | Attachment | |||||||
valueReference | Reference(Binary) | |||||||
property:BatchSize | SΣ | 1..1 | BackboneElement | General characteristics of this item | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | SΣ | 1..1 | CodeableConcept | Batch Quantity Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |||||
version | 0..1 | string | Version of the system - if relevant | |||||
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: batchsize | |||||
display | 1..1 | string | Representation defined by the system Fixed Value: Batch Quantity | |||||
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
text | 0..1 | string | Plain text representation of the concept | |||||
value[x] | Σ | 0..1 | Quantity | A value for the characteristic | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
value | Σ | 0..1 | decimal | Numerical value (with implicit precision) | ||||
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
unit | SΣ | 1..1 | string | Quantity UOM | ||||
system | ΣC | 0..1 | uri | System that defines coded unit form | ||||
code | SΣC | 1..1 | code | Coded form of the unit Binding: Units Of Measure (required) | ||||
property:BatchUtil | SΣ | 1..* | BackboneElement | General characteristics of this item | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | Σ | 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. Required Pattern: At least the following | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |||||
version | 0..1 | string | Version of the system - if relevant | |||||
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: BatchUtil | |||||
display | 1..1 | string | Representation defined by the system Fixed Value: Batch Utilization | |||||
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
text | 0..1 | string | Plain text representation of the concept | |||||
value[x] | SΣ | 1..1 | CodeableConcept | Batch Utilization | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
coding | Σ | 0..* | Coding | Code defined by a terminology system Binding: Batch utilization Terminology (required) | ||||
text | Σ | 0..1 | string | Plain text representation of the concept | ||||
property:AddInfo | SΣ | 0..1 | BackboneElement | General characteristics of this item | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | SΣ | 1..1 | CodeableConcept | Batch Formula Additional Information Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |||||
version | 0..1 | string | Version of the system - if relevant | |||||
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: AddInfo | |||||
display | 1..1 | string | Representation defined by the system Fixed Value: Product Part Additional Information | |||||
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
text | 0..1 | string | Plain text representation of the concept | |||||
value[x] | Σ | 0..1 | markdown | A value for the characteristic | ||||
component | 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 | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | SΣ | 1..1 | CodeableConcept | Product Part Type Binding: Product Part Type Terminology (required) | ||||
function | Σ | 0..* | CodeableConcept | The function of this component within the item e.g. delivers active ingredient, masks taste | ||||
Slices for amount | 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 | ||||
amount:perBatch | SΣ | 1..1 | Quantity | Component Quantity Per Batch | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
value | SΣ | 1..1 | decimal | Numerical value (with implicit precision) | ||||
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
unit | SΣ | 1..1 | string | Unit representation | ||||
system | ΣC | 0..1 | uri | System that defines coded unit form | ||||
code | SΣC | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) | ||||
amount:percent | 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) | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
value | SΣ | 1..1 | decimal | Numerical value (with implicit precision) | ||||
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
unit | SΣ | 1..1 | string | Unit representation | ||||
system | ΣC | 0..1 | uri | System that defines coded unit form | ||||
code | SΣC | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) | ||||
constituent | 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) | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
additional-info | S | 0..1 | markdown | Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension | ||||
formulaIngredient | S | 0..1 | (Complex) | Product Batch Ingredient Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension | ||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
Slices for amount | 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 | ||||
amount:perBatch | SΣ | 1..1 | Quantity | Component Quantity Per Batch | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
value | SΣ | 1..1 | decimal | Numerical value (with implicit precision) | ||||
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
unit | SΣ | 1..1 | string | Unit representation | ||||
system | ΣC | 0..1 | uri | System that defines coded unit form | ||||
code | SΣC | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) | ||||
amount:percent | SΣ | 1..1 | Quantity | Quantity Percent | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
value | SΣ | 1..1 | decimal | Numerical value (with implicit precision) | ||||
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
unit | SΣ | 1..1 | string | Unit representation | ||||
system | ΣC | 0..1 | uri | System that defines coded unit form | ||||
code | SΣC | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) | ||||
location | SΣ | 0..* | CodeableConcept | Product Part Ingredient Physical Location | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
coding | Σ | 0..* | Coding | Code defined by a terminology system Binding: Ingredient Location Terminology (required) | ||||
text | Σ | 0..1 | string | Plain text representation of the concept | ||||
function | Σ | 0..* | CodeableConcept | The function of this constituent within the component e.g. binder | ||||
hasIngredient | SΣ | 1..1 | CodeableReference(Drug Product Batch Formula Ingredient) | The ingredient that is the constituent of the given component | ||||
Slices for property | SΣ | 1..3 | See property (ManufacturedItemDefinition) | General characteristics of this component Slice: Unordered, Closed by value:type | ||||
property:PPiD | SΣ | 1..1 | BackboneElement | General characteristics of this component | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | 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. Required Pattern: At least the following | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |||||
version | 0..1 | string | Version of the system - if relevant | |||||
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: PPiD | |||||
display | 1..1 | string | Representation defined by the system Fixed Value: Product Part Identifier | |||||
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
text | 0..1 | string | Plain text representation of the concept | |||||
value[x] | SΣ | 1..1 | CodeableConcept | A value for the characteristic | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
text | SΣ | 1..1 | string | Product Part Identifier | ||||
property:PPiDref | SΣ | 0..1 | BackboneElement | General characteristics of this component | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | 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. Required Pattern: At least the following | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |||||
version | 0..1 | string | Version of the system - if relevant | |||||
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: PPiDref | |||||
display | 1..1 | string | Representation defined by the system Fixed Value: Product Part Identifier Reference | |||||
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
text | 0..1 | string | Plain text representation of the concept | |||||
value[x] | SΣ | 1..1 | CodeableConcept | A value for the characteristic | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
text | SΣ | 1..1 | string | Product Part Identifier Reference | ||||
property:AddInfo | SΣ | 0..1 | BackboneElement | General characteristics of this component | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | SΣ | 1..1 | CodeableConcept | Batch Component Additional Information Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |||||
version | 0..1 | string | Version of the system - if relevant | |||||
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: AddInfo | |||||
display | 1..1 | string | Representation defined by the system Fixed Value: Product Part Additional Information | |||||
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
text | 0..1 | string | Plain text representation of the concept | |||||
value[x] | Σ | 0..1 | markdown | A value for the characteristic | ||||
component | Σ | 0..* | See component (ManufacturedItemDefinition) | A component that this component contains or is made from | ||||
Documentation for this format |
Path | Conformance | ValueSet / Code | URI |
ManufacturedItemDefinition.meta.security | extensible | AllSecurityLabelshttp://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard | |
ManufacturedItemDefinition.meta.tag | example | CommonTagshttp://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard | |
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 | Pattern: batchsize("Batch Quantity")http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard | |
ManufacturedItemDefinition.property:BatchSize.value[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard | |
ManufacturedItemDefinition.property:BatchSize.value[x].code | required | PqcmcUnitsMeasurehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG | |
ManufacturedItemDefinition.property:BatchUtil.type | example | Pattern: BatchUtil("Batch Utilization")http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard | |
ManufacturedItemDefinition.property:BatchUtil.value[x].coding | required | PqcmcBatchUtilizationTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology from this IG | |
ManufacturedItemDefinition.property:AddInfo.type | example | Pattern: AddInfo("Product Part Additional Information")http://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.coding | required | PqcmcProductPartIngredientPhysicalLocationhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG | |
ManufacturedItemDefinition.component.property:PPiD.type | example | Pattern: PPiD("Product Part Identifier")http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard | |
ManufacturedItemDefinition.component.property:PPiDref.type | example | Pattern: PPiDref("Product Part Identifier Reference")http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard | |
ManufacturedItemDefinition.component.property:AddInfo.type | example | Pattern: AddInfo("Product Part Additional Information")http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
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: 27 elements(4 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:
Differential View
This structure is derived from ManufacturedItemDefinition
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
ManufacturedItemDefinition | ManufacturedItemDefinition | |||
meta | ||||
profile | S | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
identifier | S | 0..1 | Identifier | optional user designated identifier |
status | S | 1..1 | code | draft | active | retired | unknown |
name | S | 1..1 | string | Product Non-proprietary Name |
manufacturedDoseForm | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required) | |
manufacturer | S | 0..* | Reference(Basic Organization) | Manufacturer of the item, one of several possible |
Slices for property | S | 2..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type |
property:BatchSize | S | 1..1 | BackboneElement | General characteristics of this item |
type | S | 1..1 | CodeableConcept | Batch Quantity Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |