control strategy

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

Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMonitoringAndControl/

SubClass Of: plan specification

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › plan specification › control strategy

Definition

plan specification consisting of one or more specifications of methods and technologies that prescribe the monitoring or regulation of process parameters, quality attributes, and process performance indicators associated with a particular process and its resulting material product

Explanatory Notes

Per ICH: A planned set of controls, derived from current product and process understanding, that assures process performance and product quality. Control strategy can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control. Per ICH: Quality risk management is used to establish the control strategy. This can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in process controls, finished product specifications, and the associated methods and frequency of monitoring and control. The control strategy should facilitate timely feedback / feedforward and appropriate corrective action and preventive action.

Examples

A control strategy for sterile filling includes gravimetric sensors to monitor and regulate fill volume (process parameter), cleanroom environmental monitoring to monitor particulate levels and temperature (quality attributes), and automated rejection of out-of-spec units. The process performance indicator is fill volume deviation rate, calculated as the percentage of vials outside volume targets; A control strategy for fed-batch cell culture includes specifying a gas controller to regulate dissolved oxygen (process parameter), a pH control loop to maintain pH within range (process parameter), and monitoring of cell viability over time as a process performance indicator. It also specifies that the glycosylation profile and aggregate levels as critical quality attributes and their periodic monitoring throughout the culture using off-line analysis

Synonyms

• control plan specification
• integrated control strategy

Adapted From

• https://database.ich.org/sites/default/files/Q10%20Guideline.pdf and ISA88

Primitive Class

This class is declared primitive and it does not have necessary and sufficient condiftions defined.

Primitive Rationale

There are insufficient constructs in this release to fully capture the structure of a control strategy.

Formal Axioms

First-Order Logic Axioms

ControlStrategy(x) → PlanSpecification(x) ∧ ∃y((ProcessParameterSpecification(y) ∨ QualityAttributeSpecification(y) ∨PerformanceIndicatorSpecification(y)) ∧ hasContinuantPartAtAllTimes(x, y))

Semi-Formal Natural Language Axioms

if x is a ‘control strategy’, then x is a ‘plan specification’ that ‘has continuant part at all times’ some y, where y is either a ‘process parameter specification’, a ‘quality attribute specification’, or a ‘performance indicator specification’

Description Logic

constr:ControlStrategy ⊑ constr:PlanSpecification

constr:ControlStrategy ⊑ ∃ bfo:has_continuant_part_at_all_times .(constr:PerformanceIndicatorSpecification ⊔ constr:ProcessParameterSpecification ⊔ constr:QualityAttributeSpecification)

SubClassOf: constr:PlanSpecification

SubClassOf: bfo:has_continuant_part_at_all_times some (constr:PerformanceIndicatorSpecification or constr:ProcessParameterSpecification or constr:QualityAttributeSpecification)