manufacturing process performance qualification specification
IRI: https://spec.industrialontologies.org/ontology/construct/ManufacturingProcessPerformanceQualificationSpecification
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingProcessLifecycle/
SubClass Of: plan specification
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › plan specification › manufacturing process performance qualification specification
Definition
plan specification that prescribes a manufacturing process performance qualification process
Explanatory Notes
1) It prescribes the manufacturing conditions, controls, testing, expected outcomes, and decision criteria for the manufacturing process performance qualification process. 2) It should specify operating parameters, processing limits, input materials, data collection and evaluation, testing and acceptance criteria, and the sampling plan. 3) It should also specify the statistical methods and provisions for handling deviations and nonconforming data that support a science- and risk-based decision about whether the process can consistently produce quality product. 4) If not previously accomplished, it should address facility design and qualification of utilities and equipment, personnel training and qualification, verification of material sources, and the validation status of analytical methods. 5) It should be reviewed and approved by the appropriate departments and the quality unit before execution of the prescribed process.
Examples
- process performance qualification (PPQ) protocol for a commercial monoclonal antibody drug substance process defining the process performance qualification (PPQ) batches, operating parameters, sampling plan, analytical testing, acceptance criteria, deviation handling, and statistical evaluation approach; process performance qualification (PPQ) specification for a biologics fill-finish process defining process conditions, in-process controls, container closure testing, sampling locations, and batch acceptance criteria;
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
See the general discussion under information content entity
Formal Axioms
First-Order Logic Axioms
LA1: ManufacturingProcessPerformanceQualificationSpecification(x) → PlanSpecification(x) ∧ ∀y (prescribes(x, y) → ManufacturingProcessPerformanceQualificationProcess(y))
LA2: PlanSpecification(x) ∧ ∃y(ManufacturingProcessPerformanceQualificationProcess(y) ∧ prescribes(x,y)) → ManufacturingProcessPerformanceQualificationSpecification(x)
Semi-Formal Natural Language Axioms
LA1: if x is a ‘manufacturing process performance qualification specification’ then x is a ‘plan specification’ and x ‘prescribes’ only ‘manufacturing process performance qualification process’
LA2: if x is a ‘plan specification’ that ‘prescribes’ some ‘manufacturing process performance qualification process’ then x is a ‘manufacturing process performance qualification specification’
Description Logic
constr:ManufacturingProcessPerformanceQualificationSpecification ⊑ constr:PlanSpecification
constr:ManufacturingProcessPerformanceQualificationSpecification ⊑ ∀ constr:prescribes .constr:ManufacturingProcessPerformanceQualificationProcess
constr:PlanSpecification ⊓ ∃ constr:prescribes .constr:ManufacturingProcessPerformanceQualificationProcess ⊑ constr:ManufacturingProcessPerformanceQualificationSpecification
SubClassOf: constr:PlanSpecification
SubClassOf: constr:prescribes only constr:ManufacturingProcessPerformanceQualificationProcess
constr:PlanSpecification and constr:prescribes some constr:ManufacturingProcessPerformanceQualificationProcess SubClassOf: constr:ManufacturingProcessPerformanceQualificationSpecification