manufacturing facility qualification process

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

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 facility qualification process

Definition

planned process performed to assure proper manufacturing facility design and commissioning and demonstrate that associated utilities and equipment perform properly under anticipated commercial operating conditions

Explanatory Notes

1) This term is used for the FDA Process Validation Stage 2 activities that precede process performance qualification (PPQ). 2) These activities include those performed to assure proper facility design and commissioning, as well as activities demonstrating that utilities and equipment are built and installed in accordance with design specifications and operate in accordance with process requirements across anticipated operating ranges. 3) Qualification activities may include selection of appropriate construction materials, operating principles, and performance characteristics; verification of installation against design specifications; and verification of operation under anticipated routine production conditions, including interventions, stoppage, and start-up.

Examples

• Manufacturing facility qualification process including commissioning and qualification of utilities before process performance qualification (PPQ); Facility qualification process verifying that cleanrooms, utilities, and production equipment are installed and operate according to design and process requirements; Qualification process for a biologics manufacturing suite demonstrating that HVAC, water systems, clean steam, and process equipment support anticipated commercial operation;

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

ManufacturingFacilityQualificationProcess(x) → PlannedProcess(x) ∧ ∃p (hasOccurrentPart(x, p) ∧ AttestingProcess(p))

Semi-Formal Natural Language Axioms

if x is a ‘manufacturing facility qualification process’ then x is a ‘planned process’ and x ‘has occurrent part’ some ‘attesting process’

Description Logic

constr:ManufacturingFacilityQualificationProcess ⊑ constr:PlannedProcess

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

SubClassOf: constr:PlannedProcess

SubClassOf: bfo:has_occurrent_part some constr:AttestingProcess