manufacturing process performance qualification process
IRI: https://spec.industrialontologies.org/ontology/construct/ManufacturingProcessPerformanceQualificationProcess
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 performance qualification process
Definition
planned process in which a previously qualified facility, utilities, and equipment are used to confirm the process design in order to demonstrate that the commercial manufacturing process performs as expected
Semi-Formal Definition:
every instance of ‘manufacturing process performance qualification process’ is defined as exactly an instance of ‘planned process’ that is ‘preceded by’ some ‘manufacturing facility qualification process’, ‘has occurrent part’ some ‘manufacturing process’, ‘has input’ some ‘plan specification’ that ‘has continuant part at all times’ some ‘control strategy’ and ‘prescribes’ some ‘manufacturing process’, and is ‘prescribed by’ some ‘manufacturing process performance qualification specification’
Explanatory Notes
1) In PPQ, trained personnel execute the commercial manufacturing process using previously qualified facility, utilities, and equipment, approved control procedures, and input materials in order to generate evidence that the process performs as expected at commercial scale. 2) PPQ is typically performed with heightened sampling, testing, and scrutiny relative to routine commercial production. 3) A successful PPQ confirms the process design and provides evidence that the commercial manufacturing process is capable of reproducible commercial manufacture.
Examples
- PPQ process for a commercial monoclonal antibody drug substance process executed at commercial scale using qualified bioreactors, utilities, and approved control procedures; PPQ process for a fed-batch cell culture process performed with heightened sampling and testing to confirm that the process design produces material meeting expected quality attributes;
Adapted From
- https://www.fda.gov/files/drugs/published/Process-Validation–General-Principles-and-Practices.pdf
Formal Axioms
First-Order Logic Definition
ManufacturingProcessPerformanceQualificationProcess(x) ↔ PlannedProcess(x) ∧ ∃q (ManufacturingFacilityQualificationProcess(q) ∧ precededBy(x, q)) ∧ ∃m (ManufacturingProcess(m) ∧ hasOccurrentPart(x, m)) ∧ ∃s (PlanSpecification(s) ∧ hasInput(x, s) ∧ ∃c (ControlStrategy(c) ∧ hasContinuantPartAtAllTimes(s, c)) ∧ ∃p (ManufacturingProcess(p) ∧ prescribes(s, p))) ∧ ∃r (ManufacturingProcessPerformanceQualificationSpecification(r) ∧ prescribedBy(x, r))
Description Logic
constr:ManufacturingProcessPerformanceQualificationProcess ≡ constr:PlannedProcess ⊓ ∃ bfo:preceded_by .constr:ManufacturingFacilityQualificationProcess ⊓ ∃ bfo:has_occurrent_part .constr:ManufacturingProcess ⊓ ∃ constr:hasInput .(constr:PlanSpecification ⊓ ∃ bfo:has_continuant_part_at_all_times .constr:ControlStrategy ⊓ ∃ constr:prescribes .constr:ManufacturingProcess) ⊓ ∃ constr:prescribedBy .constr:ManufacturingProcessPerformanceQualificationSpecification
constr:ManufacturingProcessPerformanceQualificationProcess ⊑ constr:PlannedProcess
EquivalentTo: constr:PlannedProcess and bfo:preceded_by some constr:ManufacturingFacilityQualificationProcess and bfo:has_occurrent_part some constr:ManufacturingProcess and constr:hasInput some (constr:PlanSpecification and bfo:has_continuant_part_at_all_times some constr:ControlStrategy and constr:prescribes some constr:ManufacturingProcess) and constr:prescribedBy some constr:ManufacturingProcessPerformanceQualificationSpecification
SubClassOf: constr:PlannedProcess