material release process

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

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

SubClass Of: planned process

Class Hierarchy

owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › material release process

Definition

planned process in which a material entity, together with relevant evidence, is assessed against specified requirements to determine whether, and under what conditions, the material entity may exit quarantine or another controlled hold and be made available for a particular use

Explanatory Notes

A material release process may involve a material entity such as an individual item, material unit, lot, batch, or another material grouping under evaluation. Exiting quarantine or another controlled hold does not necessarily mean that the material is used immediately; it means that the material is no longer restricted from the particular use for which the assessment was performed and may be stored, transferred, or otherwise made available for that use in accordance with applicable procedures. The assessment may include review of identity, sampling, testing, examination, documentation, and other specified criteria. ICH Q7 requires materials to be held under quarantine until they have been sampled, examined or tested as appropriate and released for use.

Examples

release of an incoming raw material lot for use in media preparation following identity and purity testing; evaluation of a production consumable against receipt inspection results and supplier documentation resulting in rejection for GMP manufacturing use; release of a process intermediate for further processing following assessment of test results and process records; release of a drug substance batch for use in formulation; conditional release of a material lot for a restricted use

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/

Primitive Class

This class is declared primitive and it does not have necessary and sufficient condiftions defined.

Primitive Rationale

There are insufficient constructs to create a set of necessary and sufficient conditions.

Formal Axioms

First-Order Logic Axioms

MaterialReleaseProcess(x) → PlannedProcess(x) ∧ ∃a∃q∃m∃h∃s∃d(Agent(a) ∧ hasParticipantAtSomeTime(x,a) ∧ MaterialConformanceSpecification(q) ∧ hasInput(x,q) ∧ (MaterialProduct(m) ∨ ProcessIntermediateMaterial(m) ∨ ProductionConsumable(m) ∨ RawMaterial(m)) ∧ hasInput(x,m) ∧ MaterialHoldState(h) ∧ hasPreMaterialState(x,h) ∧ isMaterialStateOf(h,m) ∧ MaterialState(s) ∧ hasPostMaterialState(x,s) ∧ isMaterialStateOf(s,m) ∧ MaterialReleaseDispositionSpecification(d) ∧ hasSpecifiedOutput(x,d) ∧ prescribes(d,s))

Semi-Formal Natural Language Axioms

if x is a ‘material release process’ then x is a ‘planned process’ that ‘has participant at some time’ some ‘agent’, ‘has input’ some ‘material conformance specification’, ‘has input’ some ‘material product’, ‘process intermediate material’, ‘production consumable’, or ‘raw material’ m, ‘has pre material state’ some ‘material hold state’ that ‘is material state of’ m, ‘has post material state’ some ‘material state’ s that ‘is material state of’ m, and ‘has specified output’ some ‘material release disposition specification’ that ‘prescribes’ s

Description Logic

SubClassOf: constr:PlannedProcess

SubClassOf: bfo:has_participant_at_some_time some constr:Agent

SubClassOf: constr:hasInput some constr:MaterialConformanceSpecification

SubClassOf: constr:hasInput some (constr:MaterialProduct or constr:ProcessIntermediateMaterial or constr:ProductionConsumable or constr:RawMaterial)

SubClassOf: constr:hasPostMaterialState some constr:MaterialState

SubClassOf: constr:hasPreMaterialState some constr:MaterialHoldState

SubClassOf: constr:hasSpecifiedOutput some constr:MaterialReleaseDispositionSpecification