manufacturing process design process
IRI: https://spec.industrialontologies.org/ontology/construct/ManufacturingProcessDesignProcess
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 design process
Definition
planned process that defines and develops the manufacturing steps, process parameters, materials, and control elements of a commercial manufacturing process in order to establish its process design
Semi-Formal Definition:
every instance of ‘manufacturing process design process’ is defined as exactly an instance of ‘planned process’ that ‘has occurrent part’ some ‘manufacturing process characterization process’, ‘has occurrent part’ some ‘process control strategy establishment’ that ‘has specified output’ some ‘control strategy’, ‘has occurrent part’ some ‘risk assessment process’, and ‘has specified output’ some ‘plan specification’ that ‘has continuant part at all times’ that same ‘control strategy’ and ‘prescribes’ some ‘manufacturing process’
Explanatory Notes
1) Process Design corresponds to Stage 1 of FDA’s Process Validation lifecycle. Its purpose is to establish the scientific and engineering understanding needed to design a robust commercial process. Activities include integration of prior knowledge, risk assessment, process characterization studies, model development, identification of critical process parameters (CPPs), classification of material attributes, establishment of operating ranges (e.g., setpoints, NORs, PARs), and definition of the control strategy. 2) In IOF Core, ‘process design’ is a synonym for ‘plan specification’.
Examples
- Manufacturing process design process for a monoclonal antibody drug substance process in which prior knowledge, risk assessment, process characterization, operating ranges, CPPs, and the control strategy are developed for the commercial process; Manufacturing process design process for a fed-batch cell culture process that defines input materials, process parameters, setpoints, normal operating ranges, proven acceptable ranges, monitoring points, and control elements;
Adapted From
- https://www.fda.gov/files/drugs/published/Process-Validation–General-Principles-and-Practices.pdf
Formal Axioms
First-Order Logic Definition
ManufacturingProcessDesignProcess(x) ↔ PlannedProcess(x) ∧ ∃c∃s∃r∃o∃cs∃p(ManufacturingProcessCharacterizationProcess(c) ∧ ProcessControlStrategyEstablishment(s) ∧ RiskAssessmentProcess(r) ∧ PlanSpecification(o) ∧ ControlStrategy(cs) ∧ ManufacturingProcess(p) ∧ hasOccurrentPart(x,c) ∧ hasOccurrentPart(x,s) ∧ hasOccurrentPart(x,r) ∧ hasSpecifiedOutput(s,cs) ∧ hasSpecifiedOutput(x,o) ∧ hasContinuantPartAtAllTimes(o,cs) ∧ prescribes(o,p))
Description Logic
constr:ManufacturingProcessDesignProcess ≡ constr:PlannedProcess ⊓ ∃ bfo:has_occurrent_part .constr:ManufacturingProcessCharacterizationProcess ⊓ ∃ bfo:has_occurrent_part .constr:ProcessControlStrategyEstablishment ⊓ ∃ bfo:has_occurrent_part .constr:RiskAssessmentProcess ⊓ ∃ constr:hasSpecifiedOutput .(constr:PlanSpecification ⊓ ∃ bfo:has_continuant_part_at_all_times .constr:ControlStrategy ⊓ ∃ constr:prescribes .constr:ManufacturingProcess)
constr:ManufacturingProcessDesignProcess ⊑ constr:PlannedProcess
EquivalentTo: constr:PlannedProcess and bfo:has_occurrent_part some constr:ManufacturingProcessCharacterizationProcess and bfo:has_occurrent_part some constr:ProcessControlStrategyEstablishment and bfo:has_occurrent_part some constr:RiskAssessmentProcess and constr:hasSpecifiedOutput some (constr:PlanSpecification and bfo:has_continuant_part_at_all_times some constr:ControlStrategy and constr:prescribes some constr:ManufacturingProcess)
SubClassOf: constr:PlannedProcess