Risked-based Cleaning Validation Process Checklist: Is Your Process Aligned?

Adopting a risk-based cleaning validation model allows organizations to optimize procedures, improve compliance, and significantly reduce the risk of product contamination. This strategic approach moves beyond simple validation exercises, helping you focus your time and resources on the areas that pose the greatest risk to product quality. It provides a scientific and justifiable framework for every decision, from process development and equipment design reviews to the selection of analytical methods.

The core principle is to use a planned set of controls derived directly from a comprehensive risk assessment of your current cleaning process. But how can you be certain your program is fully aligned with this modern, efficient approach? This checklist is designed to give you a clear answer and help you prepare to meet today's regulatory requirements. Download the checlist below to perform a self-assessment of your program.