Process validation

Decision to master

Build a validation strategy demonstrating sustained control of a pharmaceutical process.

Learning objectives

• Explain the quality intent associated with "Validation".
• Identify the risks, responsibilities and evidence expected in a professional situation.
• Formulate a proportionate, traceable and defensible decision.

Indicative programme

1. Validation lifecycle: design, qualification, PPQ
2. Risk-based approach: critical parameters, quality attributes
3. PPQ: number of batches, acceptance criteria, statistical analysis
4. Continued process verification: CPV, drift, triggered revalidation

Prerequisites

• GMP fundamentals and quality system
• Validation and qualification DQ/IQ/OQ/PQ (or equivalent experience)