process control strategy establishment

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

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 › process control strategy establishment

Definition

planned process that uses scientific understanding of how process parameters and material attributes influence quality and performance outcomes to create a control strategy

Semi-Formal Definition:

every instance of ‘process control strategy establishment’ is defined as exactly an instance of ‘planned process’ that is ‘preceded by’ some ‘manufacturing process characterization process’ and ‘has specified output’ some ‘control strategy’

Examples

• Process control strategy establishment for a monoclonal antibody cell culture process using characterization data to define critical process parameters (CPP) controls, monitoring points, and response actions; Process control strategy establishment for a purification process using process characterization results to define chromatography operating ranges, impurity controls, and in-process testing; Process control strategy establishment using design of experiments (DoE) and risk assessment outputs to define setpoints, normal operating ranges, proven acceptable ranges, and material attribute controls;

Adapted From

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

Formal Axioms

First-Order Logic Definition

ProcessControlStrategyEstablishment(x) ↔ PlannedProcess(x) ∧ ∃p (ManufacturingProcessCharacterizationProcess(p) ∧ precededBy(x, p)) ∧ ∃c (ControlStrategy(c) ∧ hasSpecifiedOutput(x, c))

Description Logic

constr:ProcessControlStrategyEstablishment ≡ constr:PlannedProcess ⊓ ∃ bfo:preceded_by .constr:ManufacturingProcessCharacterizationProcess ⊓ ∃ constr:hasSpecifiedOutput .constr:ControlStrategy

constr:ProcessControlStrategyEstablishment ⊑ constr:PlannedProcess

EquivalentTo: constr:PlannedProcess and bfo:preceded_by some constr:ManufacturingProcessCharacterizationProcess and constr:hasSpecifiedOutput some constr:ControlStrategy

SubClassOf: constr:PlannedProcess