Generated Narrative: StructureDefinition pqcmc-product-batch-formula Name Flags Card. Type Description & Constraints ManufacturedItemDefinition ManufacturedItemDefinition #xD; identifier S 0..1 Identifier optional user designated identifier #xD; status S 1..1 code draft | active | retired | unknown #xD; name S 1..1 string Product Non-proprietary Name #xD; manufacturedDoseForm 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required) #xD; manufacturer S 0..* LiteralReference(Basic Organization) {b} Manufacturer of the item, one of several possible #xD; Slices for property S 2..* 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; property:BatchSize S 1..1 BackboneElement Batch Quantity #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Batch Quantity #xD; value[x] S 1..1 Quantity A value for the characteristic Binding: Units Of Measure (required) #xD; value S 1..1 decimal Numerical value (with implicit precision) #xD; code 0..1 code Quantity UOM #xD; property:BatchUtil S 1..* BackboneElement Batch Utilization #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Batch Utilization #xD; value[x] S 1..1 CodeableConcept A value for the characteristic Binding: Batch utilization Terminology (required) #xD; <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.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 Batch Formula Additional Information #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Batch Formula Additional Information #xD; value[x] S 1..1 markdown A value for the characteristic #xD; 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 #xD; type S 1..1 CodeableConcept Product Part Type Binding: Product Part Type Terminology (required) #xD; 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 #xD; amount:perBatch S 1..1 Quantity Component Quantity Per Batch #xD; value S 1..1 decimal Numerical value (with implicit precision) #xD; unit S 1..1 string Unit representation #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 total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) #xD; value S 1..1 decimal Numerical value (with implicit precision) #xD; unit S 1..1 string Unit representation #xD; code S 1..1 code Coded form of the unit Binding: Percentage Units (required) #xD; 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) #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension: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 #xD; extension:ingredientOverage S 0..1 (Complex) Overage Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension #xD; extension:StrengthTextual S 0..1 string Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension #xD; 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 #xD; amount:perBatch S 1..1 Quantity Component Quantity Per Batch #xD; value S 1..1 decimal Numerical value (with implicit precision) #xD; unit S 1..1 string Unit representation #xD; code S 1..1 code Coded form of the unit Binding: Non-Percentage Units (required) #xD; <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.constituent.amount:percent" title="Slice percent: Quantity expressed as Volume To Volume: The percentage of the component in the batch [Source: SME Defined]#xA;Quantity UOM: A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI E - C25709]">amount:percent S 1..1 Quantity Quantity Percent #xD; value S 1..1 decimal Numerical value (with implicit precision) #xD; unit S 1..1 string Unit representation #xD; code S 1..1 code Coded form of the unit Binding: Percentage Units (required) #xD; location S 0..* CodeableConcept Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required) #xD; hasIngredient S 1..1 LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b} The ingredient that is the constituent of the given component #xD; Slices for property S 1..* 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-batch-formula-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; <a href="StructureDefinition-pqcmc-product-batch-formula-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; component S 0..* A component that this component contains or is made from #xD; Documentation for this format
HL7 International / Biomedical Research and Regulation
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.
The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
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
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
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
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
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
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 amount of material in a specific batch size [Source: SME Defined] Example: 1000 kg
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 named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI EVS - C25709]
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
A categorization of the batch that identifies its usage. [Source: SME Defined] Examples: commercial, development.
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.
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
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.
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 function of this component within the item e.g. delivers active ingredient, masks taste
The function of this component within the item e.g. delivers active ingredient, masks taste.
The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume).
Specifies the amount of the component per batch size of the drug product. [Source: SME Defined]
A computer processable form of the unit in some unit representation system.
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)
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).
Drug Product Constituent Additional Information
A placeholder for providing any comments relevant to the constituent [Source: SME Defined] Examples: Water for wet granulation - removed during process; adjusted for loss on drying, etc.* property[
Extension for measurements related to excess for ingredients in the batch formula.
extension.where(url='proportionDecimal').single().value < 1
Product Batch Strength Textual Extension
Extension for strength as a string for ingredients in the batch formula.
The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
The measurable amount of the substance, expressable in different ways (e.g. by mass or volume).
Quantity expressed as Volume To Volume: The percentage of the component in the batch [Source: SME Defined] Quantity UOM: A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI E - C25709]
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
The function of this constituent within the component e.g. binder.
The ingredient that is the constituent of the given component
The ingredient that is the constituent of the given component.
General characteristics of this 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.
A component that this component contains or is made from
A component that this component contains or is made from.