Module 3 Presentations

07/05/2024

Analytical QbD Elements

Definition of CQA Define characteristics of measurement system which will ensure accurate assessment of quality attributes over product lifecycle Method Design Measurement technique selection and initial method development experiments to define knowledge space Risk Assessment Identification of method parameters and assessment of their impact on method performance Method Evaluation Assessment of experimental results and impact of method parameters on method performance. Define and verify Method Operable Design Region. Define and validate Normal Operating Conditions.

Definition of Method Control Strategy Establish critical method parameters. Define system suitability test to evaluate critical method attributes

Lifecycle Management Plan Define post approval management plan

The Organisation for Professionals in Regulatory Affairs

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Solid Oral Dosage New Method. Investigation at P&G Increasing peak capacity – Investigation of flow rate, gradient slope and Temperature through a QbD approach

No Peaks

Software assisted method development  DOE to screen interactions between parameters and build separation model.

Asymmetry

Goals of the separation.

Resolution

Results: Any white space on the trellis graph means goals are met

Width

The Organisation for Professionals in Regulatory Affairs

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