Generated Narrative: StructureDefinition pqcmc-product-part Name Flags Card. Type Description & Constraints ManufacturedItemDefinition <a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R5/conformance-rules.html#constraints" title="This element has or is affected by constraints ( cmc-capsule-count-required, cmc-arbitrary-unit-text-required, cmc-coating-indication-required, cmc-tablet-layer-count-required, cmc-tablet-bead-count-required, cmc-capsule-classification-required, cmc-component-id-ref )">C 0..* ManufacturedItemDefinition The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product Constraints: cmc-capsule-count-required, cmc-arbitrary-unit-text-required, cmc-coating-indication-required, cmc-tablet-layer-count-required, cmc-tablet-bead-count-required, cmc-capsule-classification-required, cmc-component-id-ref #xD; identifier S 0..1 Identifier Unique identifier #xD; status S 1..1 code draft | active | retired | unknown #xD; <a href="StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.name" title="Product Proprietary Name: The exclusive name of a drug product owned by a company under trademark law regardless of registration status with the Patent and Trademark Office (PTO). [Source: SME Defined] Note: Excludes dosage form, route of administration and strength. #xA;Example: Tylenol#xA;#xA;Product Non-proprietary Name: A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional. [Source: SME Defined]">name S 0..1 string Product Proprietary Name | Product Non-proprietary Name #xD; manufacturedDoseForm 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required) #xD; Slices for property S 6..* BackboneElement General characteristics of this item Slice: Unordered, Closed by value:type.text #xD; property:All Slices Content/Rules for all slices #xD; type S 1..1 CodeableConcept A code expressing the type of characteristic #xD; text S 1..1 string Plain text representation of the concept #xD; <a href="StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:OvrRelsProf" title="Slice OvrRelsProf: The overall release profile is the drug release profile (e.g., IR, DR, or ER-USP nomenclature) that is achieved by the drug delivery system used in the dosage form design as evident from the pharmacokinetic plasma drug concentration versus time curve (this is currently focused on solids).#xA;For example, a capsule filled with IR and DR beads will exhibit an ER release profile as evident from the pharmacokinetic curve. In this example, the "product overall release profile" is "ER". [Source: SME Defined]">property:OvrRelsProf S 1..1 BackboneElement Product Overall Release Profile #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Product Overall Release Profile #xD; value[x] S 1..1 CodeableConcept A value for the characteristic Binding: Release Profile Terminology (required) #xD; property:OvrRelsMech S 0..1 BackboneElement Product Overall Release Mechanism #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Product Overall Release Mechanism #xD; value[x] S 1..1 CodeableConcept A value for the characteristic Binding: Release Mechanism Terminology (required) #xD; property:CoatInd S 0..1 BackboneElement Product Coating Indicator #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Coating Indicator #xD; value[x] S 1..1 boolean A value for the characteristic #xD; property:LayCnt S 0..1 BackboneElement Product Tablet Layer Count #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Tablet Layer Count #xD; value[x] S 1..1 Quantity A value for the characteristic Required Pattern: At least the following #xD; system 1..1 uri System that defines coded unit form Fixed Value: http://unitsofmeasure.org #xD; code 1..1 code Coded form of the unit Fixed Value: 1 #xD; value S 1..1 decimal Numerical value (with implicit precision) #xD; property:BeaTypCnt S 0..1 BackboneElement Tablet Bead Type Count #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Tablet Bead Type Count #xD; value[x] S 1..1 Quantity A value for the characteristic Required Pattern: At least the following #xD; system 1..1 uri System that defines coded unit form Fixed Value: http://unitsofmeasure.org #xD; code 1..1 code Coded form of the unit Fixed Value: 1 #xD; value S 1..1 decimal Numerical value (with implicit precision) #xD; property:CapClass S 0..1 BackboneElement Capsule Shell Part Classification Category #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Capsule Classification Category #xD; value[x] S 1..1 CodeableConcept A value for the characteristic Binding: Capsule Shell Classification Terminology (required) #xD; property:CapConCnt S 0..1 BackboneElement Product Capsule Constituent Count #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Capsule Constituent Count #xD; value[x] S 1..1 Quantity A value for the characteristic Required Pattern: At least the following #xD; system 1..1 uri System that defines coded unit form Fixed Value: http://unitsofmeasure.org #xD; code 1..1 code Coded form of the unit Fixed Value: 1 #xD; value S 1..1 decimal Numerical value (with implicit precision) #xD; property:Schematic S 1..* BackboneElement Product Schematic #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Product Schematic #xD; value[x] S 1..1 GraphicAttachment, PDFAttachment A value for the characteristic #xD; property:WgtTyp S 1..1 BackboneElement Product Weight Type #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Product Weight Type #xD; value[x] S 1..1 CodeableConcept A value for the characteristic Binding: Strength Type Terminology (required) #xD; property:TotWgtNum S 1..1 BackboneElement Product Total Weight Numeric Numerator #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Product Total Weight Numeric Numerator #xD; value[x] S 1..1 Quantity A value for the characteristic Binding: Units Of Measure (extensible) #xD; comparator S 0..1 code Product Total Weight Operator #xD; property:TotWgtDen S 0..1 BackboneElement Product Total Weight Numeric Denominator #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Product Total Weight Numeric Denominator #xD; value[x] S 1..1 SimpleQuantity A value for the characteristic Binding: Units Of Measure (extensible) #xD; value S 1..1 decimal Numerical value (with implicit precision) #xD; property:TotWgtTxt S 0..1 BackboneElement Product Total Weight Textual #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Total Weight Textual #xD; value[x] S 1..1 markdown A value for the characteristic #xD; property:QualStd S 1..* BackboneElement Product Quality Standard #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Quality Standard #xD; value[x] S 1..1 CodeableConcept A value for the characteristic Binding: Quality Benchmark Terminology (required) #xD; property:Sterile S 1..1 BackboneElement Sterile Product Indicator #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Sterile Product Indicator #xD; value[x] S 1..1 boolean A value for the characteristic #xD; component S<a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R5/conformance-rules.html#constraints" title="This element has or is affected by constraints ( cmc-amount-ratio-or-quantity )">C 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 Constraints: cmc-amount-ratio-or-quantity #xD; Slices for modifierExtension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; modifierExtension:amountRatio S 0..1 Ratio Amount Ratio URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio #xD; type S 1..1 CodeableConcept Product Part Type #xD; coding 0..* Coding Code defined by a terminology system Binding: Product Part Type Terminology (required) #xD; function S 0..* CodeableConceptTextOnly Product Part Function Description #xD; Slices for amount S 1..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, Open by value:code #xD; amount:weight S 0..1 Quantity The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) #xD; value S 1..1 decimal Product Part Total Weight Numeric #xD; unit S 1..1 string Product Part Total Weight Numeric UOM #xD; code 0..1 code Coded form of the unit Binding: Non-Percentage Units (required) #xD; 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) #xD; value S 1..1 decimal Product Part Content Percent #xD; unit S 1..1 string Product Part Content Percent UOM #xD; code 0..1 code Coded form of the unit Binding: Percentage Units (required) #xD; constituent S<a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R5/conformance-rules.html#constraints" title="This element has or is affected by constraints ( cmc-ingredient-functions, cmc-amount-ratio-or-quantity )">C 1..* BackboneElement Product Part Ingredient Component Function Category Constraints: cmc-ingredient-functions, cmc-amount-ratio-or-quantity #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:textualStrength S 0..1 (Complex) Original Text that represents the data as seen/selected/uttered originally URL: http://hl7.org/fhir/StructureDefinition/originalText #xD; value[x] 1..1 string Textual Strength #xD; Slices for modifierExtension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; modifierExtension:amountRatio S 0..1 Ratio Amount Ratio URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio #xD; Slices for amount S 1..2 Quantity The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code #xD; amount:weight S 0..1 Quantity The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) #xD; <a href="StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.constituent.amount:weight.value" title="Specifies the quantity of an ingredient in a single part of the drug product. [Source: SME Defined]#xA;Note: a single part of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule#xA;Note: Amount can also be referred to as potency in biologics and other products.">value S 1..1 decimal Product Part Ingredient Amount Numeric #xD; unit S 1..1 string Product Part Ingredient Amount Numeric UOM #xD; code S 1..1 code Coded form of the unit Binding: Non-Percentage Units (required) #xD; amount:percent S 1..1 Quantity The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) #xD; value S 1..1 decimal Product Part Ingredient Content Percent #xD; unit S 1..1 string Product Part Ingredient Content Percent UOM #xD; code 0..1 code Coded form of the unit Binding: Percentage Units (required) #xD; location S 0..* CodeableConcept Product Part Ingredient Physical Location #xD; coding S 1..1 Coding Code defined by a terminology system Binding: Ingredient Location Terminology (required) #xD; text S 0..1 string Plain text representation of the concept #xD; Slices for function S 1..2 CodeableConcept The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:$this #xD; function:Category S 1..1 CodeableConcept The function of this constituent within the component e.g. binder Binding: Drug Product Component Function Category Terminology (required) #xD; function:Function S 0..1 CodeableConcept Product Part Ingredient Function Binding: Excipient Function Terminology (required) #xD; hasIngredient S 1..1 LiteralCodeableReference(Drug Product Component) {b} The ingredient that is the constituent of the given component #xD; Slices for property S 2..* BackboneElement General characteristics of this component Slice: Unordered, Closed by value:type.text #xD; property:All Slices Content/Rules for all slices #xD; type S 1..1 CodeableConcept A code expressing the type of characteristic #xD; text S 1..1 string Plain text representation of the concept #xD; property:PPiD S 1..1 BackboneElement Product Part Identifier #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Product Part Identifier #xD; value[x] S 1..1 CodeableConceptTextOnly A value for the characteristic #xD; <a href="StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.property:PPiDref" title="Slice PPiDref: Identifies the parent or outer-level product part. [Source: SME Defined]#xA;Example: A bead (Product Part Identifier = “B1”) has a seal coating (Product Part Identifier = “SCoat”) and is contained in a Hard HPMC capsule shell (Product Part Identifier “Cap Shell”). For the seal coating, Product Part Identifier Reference = “B1”, because the seal coat is applied to the bead.">property:PPiDref S 0..1 BackboneElement Product Part Identifier Reference #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Product Part Identifier Reference #xD; value[x] S 1..1 CodeableConceptTextOnly A value for the characteristic #xD; property:RelsProf S 1..1 BackboneElement Product Part Release Profile #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Product Part Release Profile #xD; value[x] S 1..1 CodeableConcept A value for the characteristic Binding: Release Profile Terminology (required) #xD; property:RelsMech S 0..1 BackboneElement Product Part Release Mechanism #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Product Part Release Mechanism #xD; value[x] S 1..1 CodeableConcept A value for the characteristic Binding: Release Mechanism Terminology (required) #xD; property:CoatPurpose S 0..* BackboneElement Coating Product Part Purpose #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Coating Product Part Purpose #xD; value[x] S 1..1 CodeableConcept A value for the characteristic Binding: Coating Purpose Terminology (required) #xD; property:Color S 0..1 BackboneElement Product Part Color Description #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Product Part Color Description #xD; value[x] S 1..1 CodeableConceptTextOnly A value for the characteristic #xD; <a href="StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.property:AddInfo" title="Slice AddInfo: A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying.#xA;Implementation note: This is represented in markdown. For multiple comments utilize markdwon formating for separation of notes.">property:AddInfo S 0..1 BackboneElement Product Part Additional Information #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Product Part Additional Information #xD; value[x] S 1..1 markdown A value for the characteristic #xD; Documentation for this format
HL7 International / Biomedical Research and Regulation
The manufactured drug product defined by all its parts or layers. If the drug product composition is homogeneous it will have a single part or component.
The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
If the resource is contained in another resource, it SHALL NOT contain nested Resources
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()
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()
If a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
Capsule constituent count is required when the dosage form is 'Capsule'
defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and code = 'C154433') implies property.where(type.text = 'Capsule Constituent Count').exists())
BR - Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual
defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( property.where( type.coding.exists( system = %system and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = %system and code = 'C75765') ).exists() implies property.where( type = 'Total Weight Textual' ).exists())
Coating indication is required when the dosage form is a tablet, lozenge or capsule
defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.text = 'Coating Indicator').exists())
Tablet layer count is required when the dosage form is a tablet
defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Layer Count' ).exists())
Tablet bead count is required when the dosage form is a tablet
defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Bead Type Count' ).exists())
when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory
defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154433' ) and component.type.coding.exists( system = %system and code = 'C203897' ) implies property.where( type.text = 'Capsule Classification Category' ).exists())
If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself
defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( component.select( property.where( type.text = 'Product Part Identifier Reference' ).select(value) ).all( text in %context.component.select( property.where( type.text = 'Product Part Identifier' ).select(value.text) ) ) and component.where( property.where( type.text = 'Product Part Identifier Reference' ).select(value.text) = property.where( type.text = 'Product Part Identifier' ).select(value.text) ).exists().not() )
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
The base language in which the resource is written.
Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Text summary of the resource, for human interpretation
A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.
Additional content defined by implementations
May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Must have either extensions or value[x], not both
May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
The status of this item. Enables tracking the life-cycle of the content.
Allows filtering of manufactured items that are appropriate for use versus not.
This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
Product Proprietary Name | Product Non-proprietary Name
Product Proprietary Name: The exclusive name of a drug product owned by a company under trademark law regardless of registration status with the Patent and Trademark Office (PTO). [Source: SME Defined] Note: Excludes dosage form, route of administration and strength. Example: Tylenol Product Non-proprietary Name: A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional. [Source: SME Defined]
Dose form as manufactured (before any necessary transformation)
Dose form as manufactured and before any transformation into the pharmaceutical product.
Manufactured Item.Manufactured Dose Form
The “real-world” units in which the quantity of the item is described
The “real-world” units in which the quantity of the manufactured item is described.
The presentation type in which an administrable medicinal product is given to a patient.
Manufacturer of the item, one of several possible
Manufactured Item.Manufacturer / Establishment (Organisation)
Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource
The ingredients of this manufactured item. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource.
This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Manufactured Item.Ingredient (see also FHIR Ingredient resource)
Manufactured Item.Physical Characteristics
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Extensions that cannot be ignored even if unrecognized
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
A code expressing the type of characteristic
This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Physical Characteristics, all attributes
Extensions are always sliced by (at least) url
A reference to a code defined by a terminology system.
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Allows for alternative encodings within a code system, and translations to other code systems.
fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
Plain text representation of the concept
A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
Very often the text is the same as a displayName of one of the codings.
The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
C*E.9. But note many systems use C*E.2 for this
fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
Physical Characteristics, attribute's value
The overall release profile is the drug release profile (e.g., IR, DR, or ER-USP nomenclature) that is achieved by the drug delivery system used in the dosage form design as evident from the pharmacokinetic plasma drug concentration versus time curve (this is currently focused on solids). For example, a capsule filled with IR and DR beads will exhibit an ER release profile as evident from the pharmacokinetic curve. In this example, the "product overall release profile" is "ER". [Source: SME Defined]
The dosage form design used to achieve an ER release profile. Examples of overall release mechanisms include osmotic pump, reservoir, and matrix. [Source: SME Defined]
A property that identifies whether the drug product contains any coatings. [Source: SME Defined]
The total number of layers in the tablet. [Source: SME Defined] Note: Non-layered tablets will be considered as one layer tablets.
Numerical value (with implicit precision)
The value of the measured amount. The value includes an implicit precision in the presentation of the value.
The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Precision is handled implicitly in almost all cases of measurement.
PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
< | <= | >= | > | ad - how to understand the value
How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
If there is no comparator, then there is no modification of the value
This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
How the Quantity should be understood and represented.
There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
The identification of the system that provides the coded form of the unit.
Need to know the system that defines the coded form of the unit.
CO.codeSystem, PQ.translation.codeSystem
A computer processable form of the unit in some unit representation system.
The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
PQ.code, MO.currency, PQ.translation.code
The total number of type of beads present in a tablet [Source: SME Defined] Example: For the case of a 1- layer tablet containing 2 types of beads, Tablet Bead Type Count = 2.
Capsule Shell Part Classification Category
Categorization of the capsule shell based on factors such as the shell’s barrier to water and oxygen, reactivity, and the material it is made of. [Source: SME Defined]
The number of distinct constituents contained in the capsule shell of the drug product. [Source: SME Defined] Example: For the case of a capsule shell filled with one type of bead and a minitablet, Constituent Type Count = 2.
The pictorial representation of the drug product. [Source: SME Defined]
A physical (content) or activity measurement of the weight of the drug product unit. [Source: SME Defined] Example: Mass, Activity
Specifies the total quantity of all ingredients in a single unit of the drug product. [Source: SME Defined] Note: a single unit of a solid oral dose form could be a tablet or a capsule
A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Note: This is typically applicable to biologics.
Product Total Weight Numeric Denominator
Specifies the quantity of the ingredient (s) consistent with a single unit dose or as expressed on the label. [Source: SME Defined] Note: For solid oral dose forms, by definition this is 1
A written description of the weight of the drug product. [Source: SME Defined] Note: This is typically applicable to biologics Example: International Units for Enzymes
The established benchmark to which the component complies. [Source: SME Defined] Examples: USP/NF, EP, Company Standard
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
The amount ratio extension and an amount with a non-percentage unit are mutually exclusive
defineVariable('system','http://unitsofmeasure.org').select( modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio') .union( amount.where( system = %system and code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units') ) ).count() = 1 )
The fields needed to represent an amount as a ratio.
the PQCMC use Case requires ingredient and part amounts be accepted as either quantities or ratios. When present, an amount representing anything but the percentage cannot be present
Identifies the kind of element, based on the design the applicant develops to achieve the desired drug product and overall release profile. [Source: SME Defined] Example: Layer, Bead, Minitablet, Capsule Shell, Coating
The main purpose for the part in the dosage form. [Source: SME Defined] Example: In a two layer tablet with two APIs: Product Part Function Description for Layer 1 = Deliver API 1 and Product Part Function Description for Layer 2 = Deliver API 2
The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
Specifies the total quantity of all ingredients in a single part of the drug product. [Source: SME Defined] Note: a single unit of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule
The percentage of the drug product as a whole, that is represented by this part. [Source: SME Defined] Example: total tablet weight = 400 mg, total weight of layer = 250 mg, then Content Percent for the layer = 62.5
The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI E C117055] Example: mg
Product Part Ingredient Component Function Category
A classification that identifies the higher level purpose of that material. [Source: SME Defined] Example: Active Ingredient, Inactive Ingredient, Adjuvant.
If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list.
function.coding.where(code = 'C42637' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists() implies function.coding.code.count() = 2
Original Text that represents the data as seen/selected/uttered originally
A human language representation of the concept (resource/element) as seen/selected/uttered by the user who entered the data and/or which represents the full intended meaning of the user. This can be provided either directly as text, or as a url that is a reference to a portion of the narrative of a resource ([DomainResource.text](http://hl7.org/fhir/R5/narrative.html) or [Composition.section.text](http://hl7.org/fhir/R5/composition-definitions.html#Composition.section.text)). When it a url, the value should end with a #{id} where the id identifies a specific portion of the referenced content (via an XHTML id attribute).
For whatever reason, the comments for the Original Text extension has a link that doesn't resolve! Overwriting it with this text resolves the IG error
Source of the definition for the extension code - a logical name or a URL.
The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R5/extensibility.html) for a list).
The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
Specifies the quantity of an ingredient in a single part of the drug product. [Source: SME Defined] Note: a single part of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule Note: Amount can also be referred to as potency in biologics and other products.
Product Part Ingredient Amount Numeric UOM
The labeled unit of measure for the content of an ingredient, expressed quantitatively per product part. [Source: Adapted for NCI EVS C117055]
Product Part Ingredient Content Percent UOM
Product Part Ingredient Physical Location
Identifies where the ingredient physically resides within the product part. [Source: SME Defined] Examples: Intragranular, Extra granular, Blend
The function of this constituent within the component e.g. binder
A sub-classification of part ingredients identifying its purpose/role in the drug product part (e.g., in the layer, bead, minitablet). [Source: SME Defined] Examples: Filler, Surfactant
The ingredient that is the constituent of the given component
General characteristics of this component
A submitter designated identifier that uniquely identifies the part within the drug product. [Source: SME Defined] Examples: 1, A1, Red bead, Blue minitablet
Identifies the parent or outer-level product part. [Source: SME Defined] Example: A bead (Product Part Identifier = “B1”) has a seal coating (Product Part Identifier = “SCoat”) and is contained in a Hard HPMC capsule shell (Product Part Identifier “Cap Shell”). For the seal coating, Product Part Identifier Reference = “B1”, because the seal coat is applied to the bead.
The behavior in which drug substance migrates from the drug product part to the surrounding environment (e.g., biological fluids, dissolution media, etc.) [Source: SME Defined]
The method employed to realize the specified part release profile. [Source: SME Defined] Example: matrix or reservoir
The reason the coating or covering was added. [Source: SME Defined] Examples: rate-controlling, color, release type, protective, taste masking.
The hue or the tint of the drug product part. [Source: SME Defined] Examples: yellow, pink, blue, pale yellow.
A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying. Implementation note: This is represented in markdown. For multiple comments utilize markdwon formating for separation of notes.
A component that this component contains or is made from