StructureDefinition-pqcmc-quality-specification

Sourcehl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0)
resourceTypeStructureDefinition
idpqcmc-quality-specification
canonicalhttp://hl7.org/fhir/us/pq-cmc/StructureDefinition/pqcmc-quality-specification
version0.1.15
statusdraft
publisherHL7 International - Biomedical Research and Regulatory WG
nameQualitySpecification
titleQuality Specification
date2023-07-17T03:00:13+00:00
descriptionA quality specification is for a drug product or drug substance (excipient, API or raw material).
jurisdictionsus
fhirVersion5.0.0
kindresource
abstractfalse
sdTtypePlanDefinition
derivationconstraint
basehttp://hl7.org/fhir/StructureDefinition/PlanDefinition
Usages
Name Flags Card. Type Description & Constraints doco
. . PlanDefinition PlanDefinition
. . . meta
. . . . profile S ..1
. . . Slices for extension 2.. Slice: Unordered, Open by value:url
. . . specificationStatus S 1..1 CodeableConcept Specification Status
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-specification-status-extension
Binding: Specification Status Terminology ( required )
. . . specificationType S 1..1 CodeableConcept Specification Type
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-specification-type-extension
Binding: Specification Type Terminology ( required )
. . . spec-additional-info S 0..1 markdown Specification Additional Information
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-additional-info-extension
. . . identifier S ..1
. . . version S 1.. Specification Version
. . . title S 1.. Specification Title
. . . subtitle S Specification Subtitle
. . . status S
. . . subject[x] S 1.. Reference (Routine Drug Product | Routine Drug Substance | Excipient Drug Substance)
. . . date S 1.. Specification Version Date
. . . useContext S Specification Status
. . . . code Required Pattern: At least the following
. . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/usage-context-type
. . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: workflow
. . . . . display 1..1 string Representation defined by the system
Fixed Value: Workflow Setting
. . . . Slices for value[x] Slice: Unordered, Open by type:$this
. . . . . value[x]:valueCodeableConcept 0..1 CodeableConcept
. . . . . . coding Binding: Specification Status Terminology ( required )
. . . approvalDate S Specification Status Date
. . . goal
. . . . description S Original Text
. . . . addresses S 1..
. . . . . coding
. . . . . . code S 1.. Aceptacnce Criteria Usage
Binding: Test Usage Terminology ( required )
. . . . . text Accpetance Criteria Usage
. . . . documentation S
. . . . . type Required Pattern: comments-on
. . . . . display S 1.. Acceptance Criteria Additional Information
. . . . target S 1..
. . . . . measure S
. . . . . . text S 1..
. . . . . Slices for detail[x] S Slice: Unordered, Open by type:$this
. . . . . . detailQuantity Quantity
. . . . . . detailRange Range
. . . . . . detailString string
. . . . . . detailInteger integer
. . . . . . detail[x]:detailQuantity S 0..1 Quantity Acceptance Criteria (Numeric)
. . . . . . . extension 1..
. . . . . . . interpretationCode S 1..1 CodeableConcept Interpretation Code
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology ( required )
. . . . . . . . value[x] Interpretation Code
. . . . . . . value S 1..
. . . . . . . unit S 1..
. . . . . . . code S 1.. Binding: Units Of Measure Terminology ( required )
. . . . . . detail[x]:detailRange S 0..1 Range Acceptance Criteria (Numeric range)
. . . . . . . low 1..
. . . . . . . . extension 1..
. . . . . . . . interpretationCodeLow S 1..1 CodeableConcept Interpretation Code
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology ( required )
. . . . . . . . . value[x] Interpretation Code
. . . . . . . . value S 1..
. . . . . . . . unit S 1..
. . . . . . . . code S 1.. Binding: Units Of Measure Terminology ( required )
. . . . . . . high 1..
. . . . . . . . extension 1..
. . . . . . . . interpretationCodeHigh S 1..1 CodeableConcept Interpretation Code
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology ( required )
. . . . . . . . . value[x] Interpretation Code
. . . . . . . . value S 1..
. . . . . . . . unit S 1..
. . . . . . . . code S 1.. Binding: Units Of Measure Terminology ( required )
. . . . . . detail[x]:detailString S 0..1 string Acceptance Criteria (Text)
. . . . . . . Slices for extension 1.. Slice: Unordered, Open by value:url
. . . . . . . interpretationCode S 1..1 CodeableConcept Interpretation Code
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology ( required )
. . . . . . . . value[x] Interpretation Code
. . . . . . . . . coding Required Pattern: At least the following
. . . . . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: C48660
. . . . . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Not Applicable
. . . . . . detail[x]:detailInteger S 0..1 integer Replicate Number
. . . . . . . value S 1..
. . . . . due .. 0
. . . action S C Test or Stage
cmc-action-code-required: If the test has a single stage or there are no stages then the code is required
. . . . Slices for extension 1.. Slice: Unordered, Open by value:url
. . . . testOrder S 1..1 decimal Test/Stage Order
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-order-extension
. . . . . value[x] S 1..
. . . . linkId S only required for staged test and alternate test
. . . . prefix S 1.. Stage Name
. . . . title S 1.. Test Name
. . . . . Slices for extension Slice: Unordered, Open by value:url
. . . . . rrt S 0..1 string Relative Retention Time
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-rrt-extension
. . . . description S Test Additional Information | Stage Additional Information
. . . . code S Not requried if test has stages and action is not first stage
. . . . . Slices for coding 2 .. Slice: Unordered, Open by pattern:$this
. . . . . . coding:testCategory 1..1
. . . . . . . code S Test Category
Binding: Test Category Terminology ( required )
. . . . . . coding:testSubCat 0..1
. . . . . . . code S Test Sub-category
Binding: Test Sub-Category Terminology ( required )
. . . . . . coding:methodOrigin 1..1
. . . . . . . code S Test Method Origin
Binding: Test Method Origin Terminology ( required )
. . . . . text S 1.. Analytical Procedure
. . . . documentation S ..1
. . . . . type Required Pattern: documentation
. . . . . label S 1.. Reference to Procedure
. . . . goalId S 1.. Reference to Acceptance Criteria
. . . . relatedAction S Alternate Test or Subsequent Stage
. . . . . targetId S
. . . . . relationship S concurrent for Alternate Test; after-end for Stage testing
. . . . selectionBehavior S Only required when relatedAction is an alternate test. Value will be exactly-one
. . . . action S Alternate if required for elaborate testing. Use testOrder decimal values to indicate group sequencing.

doco Documentation for this format

Produced 08 Sep 2023