manufacturing process qualification process

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

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

SubClass Of: planned process

Class Hierarchy

owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › manufacturing process qualification process

Definition

planned process in which a manufacturing process design is evaluated, through facility design assurance, qualification of utilities and equipment, and process performance qualification, to determine whether it is capable of reproducible commercial manufacture

Explanatory Notes

1) Process qualification corresponds to Stage 2 of FDA’s process-validation lifecycle. It includes activities to assure proper facility design and commissioning and to qualify utilities and equipment, followed by process performance qualification. These two elements are sometimes referred to in industry as Stage 2A and Stage 2B. PPQ batch execution and associated analytical evaluation provide evidence used to determine whether the process is capable of reproducible commercial manufacture. Process qualification relies on knowledge generated during Stage 1 Process Design, including manufacturing process characterization, and precedes Stage 3 Continued Process Verification. 2) In IOF Core, ‘process design’ is a synonym for ‘plan specification’.

Examples

• Process qualification for a commercial monoclonal antibody drug substance process, including facility and equipment qualification followed by process performance qualification (PPQ) batch execution; Process qualification for a fed-batch cell culture process where qualified bioreactors, utilities, and control procedures are used before process performance qualification (PPQ) runs demonstrate reproducible commercial performance; Process qualification for a downstream purification process including qualification of chromatography skids, filtration equipment, utilities, and process performance qualification (PPQ) execution at commercial scale;

Adapted From

• https://www.fda.gov/files/drugs/published/Process-Validation–General-Principles-and-Practices.pdf

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

ManufacturingProcessQualificationProcess(x) → PlannedProcess(x) ∧ ∃d (precededBy(x, d) ∧ ManufacturingProcessDesignProcess(d)) ∧ ∃f (hasOccurrentPart(x, f) ∧ ManufacturingFacilityQualificationProcess(f)) ∧ ∃p (hasOccurrentPart(x, p) ∧ ManufacturingProcessPerformanceQualificationProcess(p))

Semi-Formal Natural Language Axioms

if x is a ‘manufacturing process qualification process’ then x is a ‘planned process’, x is ‘preceded by’ some ‘manufacturing process design process’, x ‘has occurrent part’ some ‘manufacturing facility qualification process’, and x ‘has occurrent part’ some ‘manufacturing process performance qualification process’

Description Logic

constr:ManufacturingProcessQualificationProcess ⊑ constr:PlannedProcess

constr:ManufacturingProcessQualificationProcess ⊑ ∃ bfo:preceded_by .constr:ManufacturingProcessDesignProcess

constr:ManufacturingProcessQualificationProcess ⊑ ∃ bfo:has_occurrent_part .constr:ManufacturingFacilityQualificationProcess

constr:ManufacturingProcessQualificationProcess ⊑ ∃ bfo:has_occurrent_part .constr:ManufacturingProcessPerformanceQualificationProcess

SubClassOf: constr:PlannedProcess

SubClassOf: bfo:preceded_by some constr:ManufacturingProcessDesignProcess

SubClassOf: bfo:has_occurrent_part some constr:ManufacturingFacilityQualificationProcess

SubClassOf: bfo:has_occurrent_part some constr:ManufacturingProcessPerformanceQualificationProcess