1 Ontology Development
- 1.1 Summary
  - 1.1.1 Qualitative View
  - 1.1.2 Quantitative View
  - 1.1.3 Detailed View

Ontology Development

Summary

Qualitative View

The focus of IDMP development work for Q4 2024 was on bridging gaps related to supply chain and manufacturing, in response to recent use cases. Most of the work involved developing competency questions related to batch tracking, filling in manufacturing details such as site (business operations) and facility related content, and revising the relationship between medicinal products, packaged medicinal products, materials, package items and other related entities to improve flow and eliminate some unnecessary complexity. The resulting ontologies are cleaner and more easily understood. Additional work will be needed in the next phase of the project to support more granular product versions, related metadata, details needed to continue to improve traceability and enable mapping across complex ERP, regulatory reporting and other systems. The Amlodipine example was extended substantially to support this initial batch tracking testing effort. Most of the work was done under two issues - IDMP-744 and the GitHub-AmlodipineExample issue, listed below.

Quantitative View

Four ontologies were added:

Addresses
USGovernmentEntitiesAndJurisdictions
CAGovernmentEntitiesAndJurisdictions
SitesAndFacilities

The following ontologies were revised and/or extended:

Ontologies	Deleted Resources	New Resources	Modified Resources

Ontologies	Deleted Resources	New Resources	Modified Resources
AmlodipineExample	3	20	14
doco	0	0	14
DocumentComponents	0	0	5
EuropeanRegistrationAuthorities	0	0	1
ISO1087-TerminologyScience	0	0	1
ISO1087-VocabularyForTermsAndDefinitions	0	0	2
ISO11238-RegistrationAuthorities	0	0	1
ISO11238-Substances	0	6	41
ISO11239-PharmaceuticalDoseForms	0	0	3
ISO11615-MedicinalProducts	0	6	38
ISO11616-PharmaceuticalProducts	0	0	1
MedicalDictionaryForRegulatoryActivities	0	0	2
NorthAmericanRegistrationAuthorities	0	0	1
Organizations	0	0	3
po	0	0	8
ProductsAndServices	5	0	4
QlairaExample	5	1	8
RegistrationAuthorities	0	0	3
StatisticalMeasures	0	0	3
StructuredCollections	0	0	3
SubstancesProductsOrganisationsReferentials	0	0	1

Detailed View

resources in 1.3.0 but not 1.4.0 release

Ontologies	resources in master_v1.3.0 but not master ontology revision

Ontologies	resources in master_v1.3.0 but not master ontology revision
ProductsAndServices	https://www.omg.org/spec/Commons/ProductsAndServices/Facility
ProductsAndServices	https://www.omg.org/spec/Commons/ProductsAndServices/Site
ProductsAndServices	https://www.omg.org/spec/Commons/ProductsAndServices/Venue
ProductsAndServices	https://www.omg.org/spec/Commons/ProductsAndServices/isSituatedAt
ProductsAndServices	https://www.omg.org/spec/Commons/ProductsAndServices/situates
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascBlisterComposition
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascPackagedMedicinalProductConstituency
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascBoxComposition
QlairaExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/QlairaExample/Qlaira-PackageItem-1x28Box-Constituency
QlairaExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/QlairaExample/Qlaira-PackageItem-6x28Box-Constituency
QlairaExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/QlairaExample/Qlaira-PackageItem-28TabletBlister-Constituency
QlairaExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/QlairaExample/Qlaira-PackageItem-3s28Box-ContainerConstituent-3x28TabletBlister
QlairaExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/QlairaExample/Qlaira-PackageItem-3x28Box-Constituency

resources in 1.4.0 but not in v1.3.0 release

Ontologies	Resources

Ontologies	Resources
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/Norvasc-PhysicalManufacturedItem-5mgTablet
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/MaterialIdentifier-InternalAmlodipineIdentifier
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascMedicinalProductIdentifier
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascAsAuthorizedMedicinalProductInTheUnitedStates
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/PGSKalamazooLocation
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/MaterialName-InternalAmlodipineMaterialName
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipinePhysicalSubstance
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascMedicinalProduct-BatchIdentifier
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/PGSKalamazooManufacturingSiteIdentifier
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascMedicinalProduct-Batch-ReleaseDate
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascMedicinalProduct-Batch
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/SubstanceIdentifier-InternalAmlodipineIdentifier
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/PfizerIncAsMarketingAuthorizationHolder
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascMarketingAuthorizationInTheUnitedStates
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/PGSKalamazooManufacturingSiteName
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascPhysicalMedicinalProduct
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/MarketingAuthorizationNumber-19787-S3
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/PGSKalamazooOperation
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/PGSKalamazooManufacturingSite
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascMedicinalProduct-Batch-ExpirationDate
QlairaExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/QlairaExample/Qlaira-PackageItem-3x28Box-ContainerConstituent-3x28TabletBlister
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ManufacturingSiteName
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ManufacturingSiteIdentifier
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/isAuthorizedForMarketingThrough
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/isAuthorizedToManufacture
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/isAuthorizedForManufacturingThrough
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/authorizesMarketingOf
ISO11238-Substances	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/ManufacturerName
ISO11238-Substances	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/MaterialName
ISO11238-Substances	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/ManufacturerIdentifier
ISO11238-Substances	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/MaterialIdentifier
ISO11238-Substances	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/identifiesSpecificationFor
ISO11238-Substances	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/hasSpecifiedIdentifier

resources modified from v1.3.0 to v1.4.0 release

Ontologies	Resources

Ontologies	Resources
ISO1087-TerminologyScience	https://www.omg.org/spec/MVF/ISO1087-TerminologyScience/Terminology
doco	http://purl.org/spar/doco/Section
doco	http://purl.org/spar/doco/Index
doco	http://purl.org/spar/doco/TableOfContents
doco	http://purl.org/spar/doco/Label
doco	http://purl.org/spar/doco/Chapter
doco	http://purl.org/spar/doco/Glossary
doco	http://purl.org/spar/doco/Colophon
doco	http://purl.org/spar/doco/BackMatter
doco	http://purl.org/spar/doco/ListOfFigures
doco	http://purl.org/spar/doco/FrontMatter
doco	http://purl.org/spar/doco/Abstract
doco	http://purl.org/spar/doco/BodyMatter
doco	http://purl.org/spar/doco/ListOfTables
doco	http://purl.org/spar/doco/List
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/MedicinalProduct
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/Scoring
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/ResultantMaterialRole
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/ProcessingMaterialRole
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ActiveIngredientEntireSubstanceBasisOfStrength
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/StartingMaterialRole
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/PackageItem
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/IntendedEffect
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/PharmaceuticalProductIdentifier
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/isProducedAtManufacturingSite
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/MarketingStatusReason
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/MarketingStatusRecord
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/OtherProductCharacteristic
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/MedicinalProductContainer
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ManufacturingAuthorization
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/PhysicalMedicinalProduct
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/Comorbidity
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ProductRole
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/Strength
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ManufacturingSite
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ActiveIngredientActiveMoietyBasisOfStrength
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ContainerConstituent
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ProductComposition
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/Batch
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ActiveIngredientReferenceSubstanceBasisOfStrength
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ContainerConstituency
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/MedicinalProductIdentifier
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ManufacturingOrBusinessOperation
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ConfidentialityIndicator

Release Notes 1.4.0

Ontology Development

Summary

Qualitative View

Quantitative View

Detailed View