Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon
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/ContainerClosure | Version: 1.1.6 | |||
| Active as of 2024-09-22 | Computable Name: ContainerClosure | |||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.52 | ||||
Container Closure for drug product referred to in Drug Product Description.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from PackagedProductDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  PackagedProductDefinition |
0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |
  packageFor |
S | 1..1 | Reference(Drug Product Description) | The product that this is a pack for |
 description |
S | 1..1 | markdown | Container Closure System Description |
| attachedDocument |
S | 0..* | Reference(Graphic Reference) | Container Closure System Depiction |
 packaging |
S | 1..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap |
  type |
S | 1..1 | CodeableConcept | The physical type of the container of the items |
  Slices for coding |
S | 2..2 | Coding | Code defined by a terminology system Slice: Unordered, Closed by value:$this |
  coding:ContainerType |
S | 1..1 | Coding | Container Type Binding: Container Type Terminology (required) |
 coding:ClosureType |
S | 1..1 | Coding | Closure Type Binding: Closure Type Terminology (required) |
| quantity |
S | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) |
 packaging |
S | 0..* | Allows containers (and parts of containers) within containers, still as a part of single packaged product | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| PackagedProductDefinition.packaging.type.coding:ContainerType | required | PqcmcContainerTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminologyfrom this IG | |
| PackagedProductDefinition.packaging.type.coding:ClosureType | required | PqcmcClosureTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminologyfrom this IG |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| PackagedProductDefinition |
0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |
 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 |
| packageFor |
SΣ | 1..1 | Reference(Drug Product Description) | The product that this is a pack for |
 status |
?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| description |
SΣ | 1..1 | markdown | Container Closure System Description |
| attachedDocument |
SΣ | 0..* | Reference(Graphic Reference) | Container Closure System Depiction |
| packaging |
SΣ | 1..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | The physical type of the container of the items Binding: PackagingType (example): A high level categorisation of a package. |
| Slices for coding |
SΣ | 2..2 | Coding | Code defined by a terminology system Slice: Unordered, Closed by value:$this |
| coding:ContainerType |
SΣ | 1..1 | Coding | Container Type Binding: Container Type Terminology (required) |
| coding:ClosureType |
SΣ | 1..1 | Coding | Closure Type Binding: Closure Type Terminology (required) |
| quantity |
SΣ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) |
| packaging |
SΣ | 0..* | See packaging (PackagedProductDefinition) | Allows containers (and parts of containers) within containers, still as a part of single packaged product |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| PackagedProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| PackagedProductDefinition.packaging.type | example | PackagingTypehttp://hl7.org/fhir/ValueSet/packaging-typefrom the FHIR Standard | |
| PackagedProductDefinition.packaging.type.coding:ContainerType | required | PqcmcContainerTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminologyfrom this IG | |
| PackagedProductDefinition.packaging.type.coding:ClosureType | required | PqcmcClosureTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminologyfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | PackagedProductDefinition | 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 | PackagedProductDefinition | 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 | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | PackagedProductDefinition | 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 | ||||
|---|---|---|---|---|---|---|---|---|
| PackagedProductDefinition |
0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
 extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package | ||||
| name |
Σ | 0..1 | string | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc | ||||
| type |
Σ | 0..1 | CodeableConcept | A high level category e.g. medicinal product, raw material, shipping container etc Binding: PackageType (example): A high level categorisation of a package. | ||||
| packageFor |
SΣ | 1..1 | Reference(Drug Product Description) | The product that this is a pack for | ||||
| status |
?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| statusDate |
Σ | 0..1 | dateTime | The date at which the given status became applicable | ||||
| containedItemQuantity |
Σ | 0..* | Quantity | A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition) | ||||
| description |
SΣ | 1..1 | markdown | Container Closure System Description | ||||
| legalStatusOfSupply |
Σ | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator | ||||
| 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 | ||||
| code |
Σ | 0..1 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product | ||||
| jurisdiction |
Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
| 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 | ||||
| copackagedIndicator |
Σ | 0..1 | boolean | Identifies if the drug product is supplied with another item such as a diluent or adjuvant | ||||
| manufacturer |
Σ | 0..* | Reference(Organization) | Manufacturer of this package type (multiple means these are all possible manufacturers) | ||||
| attachedDocument |
SΣ | 0..* | Reference(Graphic Reference) | Container Closure System Depiction | ||||
| packaging |
SΣ | 1..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap | ||||
| 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 | ||||
| identifier |
Σ | 0..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier | ||||
| type |
SΣ | 1..1 | CodeableConcept | The physical type of the container of the items Binding: PackagingType (example): A high level categorisation of a package. | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| Slices for coding |
SΣ | 2..2 | Coding | Code defined by a terminology system Slice: Unordered, Closed by value:$this | ||||
| coding:ContainerType |
SΣ | 1..1 | Coding | Container Type Binding: Container Type Terminology (required) | ||||
| coding:ClosureType |
SΣ | 1..1 | Coding | Closure Type Binding: Closure Type Terminology (required) | ||||
| text |
Σ | 0..1 | string | Plain text representation of the concept | ||||
| componentPart |
Σ | 0..1 | boolean | Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial) | ||||
| quantity |
SΣ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) | ||||
| material |
Σ | 0..* | CodeableConcept | Material type of the package item Binding: PackageMaterial (example): A material used in the construction of packages and their components. | ||||
| alternateMaterial |
Σ | 0..* | CodeableConcept | A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: PackageMaterial (example): A material used in the construction of packages and their components. | ||||
| shelfLifeStorage |
Σ | 0..* | ProductShelfLife | Shelf Life and storage information | ||||
| manufacturer |
Σ | 0..* | Reference(Organization) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) | ||||
| property |
Σ | 0..* | 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. | ||||
 value[x] |
Σ | 0..1 | A value for the characteristic | |||||
| valueCodeableConcept |
CodeableConcept | |||||||
| valueQuantity |
Quantity | |||||||
| valueDate |
date | |||||||
| valueBoolean |
boolean | |||||||
| valueAttachment |
Attachment | |||||||
| containedItem |
Σ | 0..* | BackboneElement | The item(s) within the packaging | ||||
| 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 | ||||
| item |
Σ | 1..1 | CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct) | The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package | ||||
| amount |
Σ | 0..1 | Quantity | The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition) | ||||
| packaging |
SΣ | 0..* | See packaging (PackagedProductDefinition) | Allows containers (and parts of containers) within containers, still as a part of single packaged product | ||||
| characteristic |
Σ | 0..* | See property (PackagedProductDefinition) | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| PackagedProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| PackagedProductDefinition.type | example | PackageTypehttp://hl7.org/fhir/ValueSet/package-typefrom the FHIR Standard | |
| PackagedProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| PackagedProductDefinition.legalStatusOfSupply.code | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supplyfrom the FHIR Standard | |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| PackagedProductDefinition.packaging.type | example | PackagingTypehttp://hl7.org/fhir/ValueSet/packaging-typefrom the FHIR Standard | |
| PackagedProductDefinition.packaging.type.coding:ContainerType | required | PqcmcContainerTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminologyfrom this IG | |
| PackagedProductDefinition.packaging.type.coding:ClosureType | required | PqcmcClosureTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminologyfrom this IG | |
| PackagedProductDefinition.packaging.material | example | PackageMaterialhttp://hl7.org/fhir/ValueSet/package-materialfrom the FHIR Standard | |
| PackagedProductDefinition.packaging.alternateMaterial | example | PackageMaterialhttp://hl7.org/fhir/ValueSet/package-materialfrom the FHIR Standard | |
| PackagedProductDefinition.packaging.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | PackagedProductDefinition | 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 | PackagedProductDefinition | 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 | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | PackagedProductDefinition | 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 PackagedProductDefinition
Summary
Mandatory: 6 elements
Must-Support: 10 elements
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Differential View
This structure is derived from PackagedProductDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| PackagedProductDefinition |
0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |
| packageFor |
S | 1..1 | Reference(Drug Product Description) | The product that this is a pack for |
| description |
S | 1..1 | markdown | Container Closure System Description |
| attachedDocument |
S | 0..* | Reference(Graphic Reference) | Container Closure System Depiction |
| packaging |
S | 1..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap |
| type |
S | 1..1 | CodeableConcept | The physical type of the container of the items |
| Slices for coding |
S | 2..2 | Coding | Code defined by a terminology system Slice: Unordered, Closed by value:$this |
| coding:ContainerType |
S | 1..1 | Coding | Container Type Binding: Container Type Terminology (required) |
| coding:ClosureType |
S | 1..1 | Coding | Closure Type Binding: Closure Type Terminology (required) |
| quantity |
S | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) |
| packaging |
S | 0..* | Allows containers (and parts of containers) within containers, still as a part of single packaged product | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| PackagedProductDefinition.packaging.type.coding:ContainerType | required | PqcmcContainerTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminologyfrom this IG | |
| PackagedProductDefinition.packaging.type.coding:ClosureType | required | PqcmcClosureTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminologyfrom this IG |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| PackagedProductDefinition |
0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |
| 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 |
| packageFor |
SΣ | 1..1 | Reference(Drug Product Description) | The product that this is a pack for |
| status |
?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| description |
SΣ | 1..1 | markdown | Container Closure System Description |
| attachedDocument |
SΣ | 0..* | Reference(Graphic Reference) | Container Closure System Depiction |
| packaging |
SΣ | 1..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | The physical type of the container of the items Binding: PackagingType (example): A high level categorisation of a package. |
| Slices for coding |
SΣ | 2..2 | Coding | Code defined by a terminology system Slice: Unordered, Closed by value:$this |
| coding:ContainerType |
SΣ | 1..1 | Coding | Container Type Binding: Container Type Terminology (required) |
| coding:ClosureType |
SΣ | 1..1 | Coding | Closure Type Binding: Closure Type Terminology (required) |
| quantity |
SΣ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) |
| packaging |
SΣ | 0..* | See packaging (PackagedProductDefinition) | Allows containers (and parts of containers) within containers, still as a part of single packaged product |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| PackagedProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| PackagedProductDefinition.packaging.type | example | PackagingTypehttp://hl7.org/fhir/ValueSet/packaging-typefrom the FHIR Standard | |
| PackagedProductDefinition.packaging.type.coding:ContainerType | required | PqcmcContainerTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminologyfrom this IG | |
| PackagedProductDefinition.packaging.type.coding:ClosureType | required | PqcmcClosureTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminologyfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | PackagedProductDefinition | 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 | PackagedProductDefinition | 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 | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| PackagedProductDefinition |
0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package | ||||
| name |
Σ | 0..1 | string | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc | ||||
| type |
Σ | 0..1 | CodeableConcept | A high level category e.g. medicinal product, raw material, shipping container etc Binding: PackageType (example): A high level categorisation of a package. | ||||
| packageFor |
SΣ | 1..1 | Reference(Drug Product Description) | The product that this is a pack for | ||||
| status |
?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| statusDate |
Σ | 0..1 | dateTime | The date at which the given status became applicable | ||||
| containedItemQuantity |
Σ | 0..* | Quantity | A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition) | ||||
| description |
SΣ | 1..1 | markdown | Container Closure System Description | ||||
| legalStatusOfSupply |
Σ | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator | ||||
| 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 | ||||
| code |
Σ | 0..1 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product | ||||
| jurisdiction |
Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
| 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 | ||||
| copackagedIndicator |
Σ | 0..1 | boolean | Identifies if the drug product is supplied with another item such as a diluent or adjuvant | ||||
| manufacturer |
Σ | 0..* | Reference(Organization) | Manufacturer of this package type (multiple means these are all possible manufacturers) | ||||
| attachedDocument |
SΣ | 0..* | Reference(Graphic Reference) | Container Closure System Depiction | ||||
| packaging |
SΣ | 1..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap | ||||
| 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 | ||||
| identifier |
Σ | 0..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier | ||||
| type |
SΣ | 1..1 | CodeableConcept | The physical type of the container of the items Binding: PackagingType (example): A high level categorisation of a package. | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| Slices for coding |
SΣ | 2..2 | Coding | Code defined by a terminology system Slice: Unordered, Closed by value:$this | ||||
| coding:ContainerType |
SΣ | 1..1 | Coding | Container Type Binding: Container Type Terminology (required) | ||||
| coding:ClosureType |
SΣ | 1..1 | Coding | Closure Type Binding: Closure Type Terminology (required) | ||||
| text |
Σ | 0..1 | string | Plain text representation of the concept | ||||
| componentPart |
Σ | 0..1 | boolean | Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial) | ||||
| quantity |
SΣ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) | ||||
| material |
Σ | 0..* | CodeableConcept | Material type of the package item Binding: PackageMaterial (example): A material used in the construction of packages and their components. | ||||
| alternateMaterial |
Σ | 0..* | CodeableConcept | A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: PackageMaterial (example): A material used in the construction of packages and their components. | ||||
| shelfLifeStorage |
Σ | 0..* | ProductShelfLife | Shelf Life and storage information | ||||
| manufacturer |
Σ | 0..* | Reference(Organization) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) | ||||
| property |
Σ | 0..* | 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. | ||||
| value[x] |
Σ | 0..1 | A value for the characteristic | |||||
| valueCodeableConcept |
CodeableConcept | |||||||
| valueQuantity |
Quantity | |||||||
| valueDate |
date | |||||||
| valueBoolean |
boolean | |||||||
| valueAttachment |
Attachment | |||||||
| containedItem |
Σ | 0..* | BackboneElement | The item(s) within the packaging | ||||
| 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 | ||||
| item |
Σ | 1..1 | CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct) | The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package | ||||
| amount |
Σ | 0..1 | Quantity | The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition) | ||||
| packaging |
SΣ | 0..* | See packaging (PackagedProductDefinition) | Allows containers (and parts of containers) within containers, still as a part of single packaged product | ||||
| characteristic |
Σ | 0..* | See property (PackagedProductDefinition) | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| PackagedProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| PackagedProductDefinition.type | example | PackageTypehttp://hl7.org/fhir/ValueSet/package-typefrom the FHIR Standard | |
| PackagedProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| PackagedProductDefinition.legalStatusOfSupply.code | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supplyfrom the FHIR Standard | |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| PackagedProductDefinition.packaging.type | example | PackagingTypehttp://hl7.org/fhir/ValueSet/packaging-typefrom the FHIR Standard | |
| PackagedProductDefinition.packaging.type.coding:ContainerType | required | PqcmcContainerTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminologyfrom this IG | |
| PackagedProductDefinition.packaging.type.coding:ClosureType | required | PqcmcClosureTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminologyfrom this IG | |
| PackagedProductDefinition.packaging.material | example | PackageMaterialhttp://hl7.org/fhir/ValueSet/package-materialfrom the FHIR Standard | |
| PackagedProductDefinition.packaging.alternateMaterial | example | PackageMaterialhttp://hl7.org/fhir/ValueSet/package-materialfrom the FHIR Standard | |
| PackagedProductDefinition.packaging.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | PackagedProductDefinition | 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 | PackagedProductDefinition | 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 | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | PackagedProductDefinition | 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 PackagedProductDefinition
Summary
Mandatory: 6 elements
Must-Support: 10 elements
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Other representations of profile: CSV, Excel, Schematron
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.1.6 based on FHIR 5.0.0. Generated 2024-09-22
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