Validation Results for FHIR_pqcmc_fda

Generated Tue Jul 08 08:01:24 UTC 2025, FHIR version 5.0.0 for hl7.fhir.us.pq-cmc-fda#2.0.0 (canonical = http://hl7.org/fhir/us/pq-cmc-fda (history)). See Full QA Report & IP

Quality Checks
Publisher Version:	IG Publisher Version: v2.0.8
Publication Code:	pq-cmc-fda . PackageId = hl7.fhir.us.pq-cmc-fda, Canonical = http://hl7.org/fhir/us/pq-cmc-fda
Realm Check for US:	Snomed: The IG doesn't use SNOMED CT 4 Profiles not based on US Core
Language Info:	This IG has no language information
Publication Request:	package-id hl7.fhir.us.pq-cmc-fda version 2.0.0 path http://hl7.org/fhir/us/pq-cmc-fda/STU2 Pub-Mode milestone status trial-use Release-Label STU2 Sequence (Group) STU2 (current: 'STU1', others = 'STU2') desc The second implementation guide release. It contains Stage 2 content: Substance Characterisation, Product Batch Formula, and Product Characterisation of Impurities. RelatedIgs (None Found) No Messages found - all good
Supressed Messages:	54 Suppressed Issues
Dependency Checks:	Package Version FHIR Canonical Web Base Comment hl7.fhir.us.pq-cmc-fda 2.0.0 R5 http://hl7.org/fhir/us/pq-cmc-fda hl7.fhir.uv.extensions.r5 5.2.0 M R5 http://hl7.org/fhir/extensions http://hl7.org/fhir/extensions/5.2.0 hl7.terminology.r5 6.4.0 O R5 http://terminology.hl7.org http://terminology.hl7.org/6.4.0 Latest Release is 6.5.0 hl7.fhir.uv.extensions.r5 5.2.0 M R5 http://hl7.org/fhir/extensions http://hl7.org/fhir/extensions/5.2.0 (as above) Templates: hl7.fhir.template#current -> hl7.base.template#current -> fhir.base.template#current. Tools: 0.5.0
Related IGs:	n/a
Dependent IGs:	no references
Global Profiles:	(none declared)
Terminology Server(s):	http://tx.fhir.org/r5, https://tx.fhir.org/r5 (details)
HTA Analysis:	All OK
R5 Dependencies:	(none)
Draft Dependencies:	hl7.fhir.r5.core#5.0.0: GuideParameterCode (15 uses), ConceptProperties (1 uses), PackagedProductDefinition (4 uses), PackageType (1 uses), LegalStatusOfSupply (5 uses), JurisdictionValueSet (51 uses), Organization (67 uses), PackagingType (1 uses), PackageMaterial (2 uses), ProductCharacteristic (43 uses), ManufacturedItemDefinition (10 uses), DeviceDefinition (8 uses), BiologicallyDerivedProduct (1 uses), NutritionProduct (1 uses), DocumentReference (99 uses), Appointment (6 uses), AppointmentResponse (3 uses), CarePlan (3 uses), Claim (3 uses), CommunicationRequest (3 uses), Contract (3 uses), CoverageEligibilityRequest (3 uses), DeviceRequest (3 uses), EnrollmentRequest (3 uses), ImmunizationRecommendation (3 uses), MedicationRequest (3 uses), NutritionOrder (3 uses), RequestOrchestration (3 uses), ServiceRequest (3 uses), SupplyRequest (3 uses), VisionPrescription (3 uses), DocumentReferenceStatus (3 uses), CompositionStatus (10 uses), FHIRDocumentTypeCodes (10 uses), ReferencedItemCategoryValueSet (10 uses), Encounter (10 uses), EpisodeOfCare (3 uses), BodyStructure (3 uses), SNOMEDCTBodyStructures (3 uses), FacilityTypeCodeValueSet (3 uses), PracticeSettingCodeValueSet (3 uses), Practitioner (30 uses), PractitionerRole (34 uses), Device (20 uses), RelatedPerson (30 uses), CareTeam (7 uses), CompositionAttestationMode (10 uses), DocumentRelationshipType (3 uses), SecurityLabelExamples (3 uses), OrganizationType (1 uses), Endpoint (5 uses), Composition (46 uses), DocumentSectionCodes (13 uses), ListOrderCodes (13 uses), ListEmptyReasons (13 uses), CodeableReference (1 uses), ResourceType (1 uses), MedicinalProductDefinition (9 uses), MedicinalProductType (4 uses), MedicinalProductDomain (11 uses), AdditionalMonitoring (4 uses), SpecialMeasures (4 uses), PediatricUse (4 uses), ProductClassification (4 uses), MedicinalProductPackageType (4 uses), SNOMEDCTSubstanceCodes (18 uses), SubstanceDefinition (102 uses), ProductContactType (4 uses), ResearchStudy (4 uses), SNOMEDCTMedicationCodes (4 uses), ProductNamePartType (4 uses), CountryValueSet (29 uses), ProductCrossReferenceType (4 uses), ActivityDefinition (7 uses), PlanDefinition (19 uses), ProductConfidentiality (4 uses), Citation (7 uses), Stereochemistry (14 uses), OpticalActivity (14 uses), SubstanceAmountType (14 uses), StructureTechnique (14 uses), SubstanceForm (7 uses), SubstanceReferenceInformation (7 uses), WeightMethod (7 uses), WeightType (7 uses), SubstanceRepresentationFormat (15 uses), SubstanceNameDomain (37 uses), SubstanceNameAuthority (37 uses), SubstanceRelationshipType (7 uses), SubstanceNucleicAcid (7 uses), SubstancePolymer (7 uses), SubstanceProtein (7 uses), SourceMaterialGenus (7 uses), SourceMaterialSpecies (7 uses), SourceMaterialPart (7 uses), Ingredient (4 uses), AdministrableProductDefinition (2 uses), IngredientFunction (2 uses), IngredientManufacturerRole (2 uses), IngredientRole (1 uses), SubstanceGrade (4 uses), SourceMaterialType (5 uses), SubstanceRepresentationType (3 uses), UnitOfPresentation (2 uses), VersionAlgorithm (1 uses), PlanDefinitionType (1 uses), DefinitionTopic (1 uses), Library (1 uses), GoalCategory (1 uses), SNOMEDCTClinicalFindings (1 uses), GoalPriority (1 uses), GoalStartEvent (1 uses), LOINCCodes (1 uses), ActionParticipantType (4 uses), Group (7 uses), HealthcareService (4 uses), Location (7 uses), RequestPriority (3 uses), ActionCode (3 uses), RelatedArtifactType (2 uses), CitationArtifactClassifier (2 uses), ParticipantResourceTypes (3 uses), ActionConditionKind (3 uses), ActionRelationshipType (6 uses), ActionParticipantFunction (3 uses), ActionType (3 uses), ActionGroupingBehavior (3 uses), ActionSelectionBehavior (3 uses), ActionRequiredBehavior (3 uses), ActionPrecheckBehavior (3 uses), ActionCardinalityBehavior (3 uses), MessageDefinition (3 uses), ObservationDefinition (3 uses), Questionnaire (3 uses), SpecimenDefinition (3 uses), StructureMap (3 uses), ActionReasonCode (2 uses), SNOMEDCTMedicationAsNeededReasonCodes (1 uses) hl7.fhir.uv.extensions.r5#5.2.0: SDStatusDerivation (182 uses), SDTypeCharacteristics (19 uses) hl7.terminology.r5#6.4.0: ContactEntityType (1 uses), ActionParticipantRole (4 uses)
Modifier Extensions:	Amount Ratio Target Range
Previous Version Comparison:	Comparison with version 2.0.0-ballot
IPA Comparison:	n/a
IPS Comparison:	n/a
Validation Flags:	On: autoLoad; Off: hintAboutNonMustSupport, anyExtensionsAllowed, checkAggregation, showReferenceMessages, noExperimentalContent, displayWarnings
Summary:	errors = 0, warn = 0, info = 0, broken links = 0, pinned = n/a. Show Message Ids

n/a Show Validation Information

Suppressed Messages (Warnings, hints, broken links)

02 - Organization conflicts with US Core Organization Profile on identifier codes. National Provider Identifier (NPI), Clinical Laboratory Improvement Amendments (CLIA) Number for laboratories, and NAIC Code are not used to identify drug suppliers. See US Core Ticket FHIR-44853

• %US FHIR Usage rules require that all profiles on DocumentReference derive from one of the base US profiles. See https://confluence.hl7.org/display/CGP/US+Core+Variance+Request+Process (3 uses)
• %US FHIR Usage rules require that all profiles on Organization derive from the core US profile. See https://confluence.hl7.org/display/CGP/US+Core+Variance+Request+Process (1 uses)

03 - This is a supplement to the NCI Thesaurus (NCIt) which is in THO. CodeSystem supplements in FHIR don't require registration with the HL7 Terminology organization because they only enhance existing CodeSystems rather than defining new ones. They add localized or context-specific information, such as additional properties or designations, without altering the base CodeSystem. This flexibility allows for tailored implementations without the overhead of global registration.

• INFORMATION: CodeSystem/cmc-hierarchy-supplement: CodeSystem: Most code systems defined in HL7 IGs will need to move to THO later during the process. Consider giving this code system a THO URL now (See https://confluence.hl7.org/display/TSMG/Terminology+Play+Book, and/or talk to TSMG) (1 uses)

04 - Using UCUM codes like %{WeightToWeight}, %{WeightToVolume}, and %{VolumeToVolume} for drug product specifications offers key advantages: they ensure consistency, reduce errors, meet regulatory requirements (e.g., eCTD, FHIR), simplify data exchange with machine-readable formats, clearly define concentration types (e.g., w/w, w/v, v/v), and support international collaboration by overcoming language and unit barriers. These codes enhance clarity, compliance, and efficiency in pharmaceutical processes, and are not being used in computations. Note: The curly brackets UCUM values will be reviewed again with HL7 in STU3

• WARNING: Bundle/BatchFormulaBundle2Layer: Bundle.entry[4].resource/*ManufacturedItemDefinition/8a3e11d9-4323-43c4-be00-8f0ea1837070*/.property[0].value.ofType(Quantity): UCUM Codes that contain human readable annotations like {tbl} can be misleading (e.g. they are ignored when comparing units). Best Practice is not to depend on annotations in the UCUM code, so this usage should be checked, and the Quantity.unit 'tablets' SHOULD contain the annotation (it does not) (1 uses)
• WARNING: Bundle/SpecificationExcipientBundle: Bundle.entry[1].resource/*PlanDefinition/37bf5cc0-33bf-478b-b84e-ccb35143ef6e*/.goal[10].target[0].detail.ofType(Quantity): UCUM Codes that contain human readable annotations like {WeightToWeight} can be misleading (e.g. they are ignored when comparing units). Best Practice is not to depend on annotations in the UCUM code, so this usage should be checked (1 uses)
• WARNING: Bundle/SpecificationExcipientBundle: Bundle.entry[1].resource/*PlanDefinition/37bf5cc0-33bf-478b-b84e-ccb35143ef6e*/.goal[11].target[0].detail.ofType(Quantity): UCUM Codes that contain human readable annotations like {WeightToWeight} can be misleading (e.g. they are ignored when comparing units). Best Practice is not to depend on annotations in the UCUM code, so this usage should be checked (1 uses)
• WARNING: Bundle/SpecificationExcipientBundle: Bundle.entry[1].resource/*PlanDefinition/37bf5cc0-33bf-478b-b84e-ccb35143ef6e*/.goal[6].target[0].detail.ofType(Quantity): UCUM Codes that contain human readable annotations like {WeightToWeight} can be misleading (e.g. they are ignored when comparing units). Best Practice is not to depend on annotations in the UCUM code, so this usage should be checked (1 uses)
• WARNING: Bundle/SpecificationExcipientBundle: Bundle.entry[1].resource/*PlanDefinition/37bf5cc0-33bf-478b-b84e-ccb35143ef6e*/.goal[9].target[0].detail.ofType(Quantity): UCUM Codes that contain human readable annotations like {WeightToWeight} can be misleading (e.g. they are ignored when comparing units). Best Practice is not to depend on annotations in the UCUM code, so this usage should be checked (1 uses)

05 - These are all inherited from Core Specification.

• %Reference to deprecated ValueSet http://hl7.org/fhir/ValueSet/jurisdiction|5.0.0 (92 uses)
• %binds to the value set 'http://hl7.org/fhir/ValueSet/country|5.0.0' which is experimental, but this structure is not labeled as experimental (5 uses)
• %binds to the value set 'http://hl7.org/fhir/ValueSet/jurisdiction' which is experimental, but this structure is not labeled as experimental (1 uses)
• %binds to the value set 'http://hl7.org/fhir/ValueSet/participant-resource-types' which is experimental, but this structure is not labeled as experimental (3 uses)
• %binds to the value set 'http://hl7.org/fhir/ValueSet/request-priority|5.0.0' which is experimental, but this structure is not labeled as experimental (3 uses)
• %binds to the value set 'http://hl7.org/fhir/ValueSet/resource-types' which is experimental, but this structure is not labeled as experimental (1 uses)
• %binds to the value set 'http://hl7.org/fhir/ValueSet/version-algorithm' which is experimental, but this structure is not labeled as experimental (1 uses)

06 - They are inline examples so that they just show in the bundles. Comes from having to restrict references to be bundled only. The usage is set to inline because the publisher does not support remote reference defined in the bundle.

• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ContainerClosure'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p10'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p32'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p55'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s10'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s3'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-batch-formula-product'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-handle'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-characterisation'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)
• INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance'): The Implementation Guide contains no explicitly linked examples for this profile (1 uses)

07 - This is a supplement to the NCI Thesaurus (NCIt) which is in THO where the display value is stored. The definition is in the NCI Thesaurus (NCIt).

• WARNING: CodeSystem/cmc-hierarchy-supplement: CodeSystem.concept[0]: HL7 Defined CodeSystems should ensure that every concept has a definition (1 uses)
• WARNING: CodeSystem/cmc-hierarchy-supplement: CodeSystem.concept[0]: HL7 Defined CodeSystems should ensure that every concept has a display (1 uses)

08 - These are abstract profiles on datatypes, and are only being used as slicing discriminators.

• WARNING: StructureDefinition/codeable-concept-text-only: StructureDefinition: CodeableConcept is labeled as an abstract type, but no concrete descendants were found (check definitions - this is usually an error unless concrete definitions are in some other package) (1 uses)
• WARNING: StructureDefinition/literal-codeable-reference: StructureDefinition: CodeableReference is labeled as an abstract type, but no concrete descendants were found (check definitions - this is usually an error unless concrete definitions are in some other package) (1 uses)
• WARNING: StructureDefinition/literal-reference: StructureDefinition: Reference is labeled as an abstract type, but no concrete descendants were found (check definitions - this is usually an error unless concrete definitions are in some other package) (1 uses)
• WARNING: StructureDefinition/pqcmc-analytical-intstrument-data: StructureDefinition: Attachment is labeled as an abstract type, but no concrete descendants were found (check definitions - this is usually an error unless concrete definitions are in some other package) (1 uses)
• WARNING: StructureDefinition/pqcmc-graphic-attachment: StructureDefinition: Attachment is labeled as an abstract type, but no concrete descendants were found (check definitions - this is usually an error unless concrete definitions are in some other package) (1 uses)
• WARNING: StructureDefinition/pqcmc-graphic-reference: StructureDefinition: DocumentReference is labeled as an abstract type, but no concrete descendants were found (check definitions - this is usually an error unless concrete definitions are in some other package) (1 uses)
• WARNING: StructureDefinition/pqcmc-pdf-attachment: StructureDefinition: Attachment is labeled as an abstract type, but no concrete descendants were found (check definitions - this is usually an error unless concrete definitions are in some other package) (1 uses)
• WARNING: StructureDefinition/pqcmc-structure-data: StructureDefinition: Attachment is labeled as an abstract type, but no concrete descendants were found (check definitions - this is usually an error unless concrete definitions are in some other package) (1 uses)
• WARNING: StructureDefinition/pqcmc-structure-reference: StructureDefinition: DocumentReference is labeled as an abstract type, but no concrete descendants were found (check definitions - this is usually an error unless concrete definitions are in some other package) (1 uses)

09 - Listed on https://www.hl7.org/fhir/R4/identifier-registry.html. URIs when the identifier is a URI. It has an infinite number of members.

• WARNING: ValueSet/pqcmc-analytical-instrument-data-types: ValueSet.compose.include[0].system: No definition could be found for URL value 'urn:ietf:bcp:13' (1 uses)
• WARNING: ValueSet/pqcmc-graphical-file-types: ValueSet.compose.include[0].system: No definition could be found for URL value 'urn:ietf:bcp:13' (1 uses)
• WARNING: ValueSet/pqcmc-structure-data-types: ValueSet.compose.include[0].system: No definition could be found for URL value 'urn:ietf:bcp:13' (1 uses)

Errors sorted by type