Process Validation Lifecycle Approach: A Return to Science

Industrial Management Consulting
Industrial Management Consulting

Program Summary
1. The expectations for process validation and process control have changed and are continuing to change – for the better.

2. More and more global health authorities and regulators are communicating their expectations for risk and science based justification for process control and validation approaches.

3. A true life cycle approach to process validation requires gathering useful, scientific information
as process and control strategies are developed, thus saving time and resources during later qualification and validation stages.

4. The key is better understanding of the process, its sources of variation and their control, and the
correlation between validation studies, sampling plans, process performance, product quality, and continued process verification.

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