material release disposition specification

IRI: https://spec.industrialontologies.org/ontology/construct/MaterialReleaseDispositionSpecification

Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMaterialTesting/

SubClass Of: material state specification

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › material state specification › material release disposition specification

Definition

material state specification that is a specified output of a material release process and specifies the post material state of the evaluated material entity with respect to a particular use

Semi-Formal Definition:

every instance of ‘material release disposition specification’ is defined as exactly an instance of ‘material state specification’ that ‘is specified output of’ some ‘material release process’ p that ‘has input’ some entity m that is a ‘material product’, ‘process intermediate material’, ‘production consumable’, or ‘raw material’, and ‘prescribes’ some ‘material state’ s that is the ‘post material state’ of p and ‘is material state of’ m

Explanatory Notes

The post material state specified by a material release disposition specification represents the status assigned to the evaluated material with respect to the relevant use, such as release from hold, conditional release, continuation of hold, or rejection.

Examples

• QA disposition specifying that raw-material lot RM-041 may be used in media preparation; material disposition specifying that process-intermediate lot INT-204 must remain on hold pending completion of an OOS investigation; material disposition specifying that drug-substance batch DS-117 may be used in formulation;

Adapted From

• https://database.ich.org/sites/default/files/Q7%20Guideline.pdf and https://pharmagmpguide.com/raw-material-receipt-sop-in-pharma/ and https://sgsystemsglobal.com/glossary/batch-release/ and https://sgsystemsglobal.com/glossary/lot-release-qa-disposition/

Formal Axioms

First-Order Logic Definition

MaterialReleaseDispositionSpecification(x) ↔ MaterialStateSpecification(x) ∧ ∃p∃m∃s(MaterialReleaseProcess(p) ∧ isSpecifiedOutputOf(x,p) ∧ hasInput(p,m) ∧ (MaterialProduct(m) ∨ ProcessIntermediateMaterial(m) ∨ ProductionConsumable(m) ∨ RawMaterial(m)) ∧ MaterialState(s) ∧ hasPostMaterialState(p,s) ∧ isMaterialStateOf(s,m) ∧ prescribes(x,s))

Description Logic

constr:MaterialReleaseDispositionSpecification ≡ constr:MaterialStateSpecification ⊓ ∃ constr:isSpecifiedOutputOf .constr:MaterialReleaseProcess ⊓ ∃ constr:prescribes .(constr:MaterialState ⊓ ∃ constr:isMaterialStateOf .(constr:MaterialProduct ⊔ constr:ProcessIntermediateMaterial ⊔ constr:ProductionConsumable ⊔ constr:RawMaterial) ⊓ ∃ constr:hasPostMaterialState⁻ .constr:MaterialReleaseProcess)

constr:MaterialReleaseDispositionSpecification ⊑ constr:MaterialStateSpecification

EquivalentTo: constr:MaterialStateSpecification and constr:isSpecifiedOutputOf some constr:MaterialReleaseProcess and constr:prescribes some (constr:MaterialState and constr:isMaterialStateOf some (constr:MaterialProduct or constr:ProcessIntermediateMaterial or constr:ProductionConsumable or constr:RawMaterial) and inverse constr:hasPostMaterialState some constr:MaterialReleaseProcess)

SubClassOf: constr:MaterialStateSpecification