Validation of Cleaning Processes

• By: Staff Editor
• Source: www.fda.gov

This document serves as a guide to investigators and other FDA personnel inspecting and validating cleaning processes.

It is designed to establish inspection consistency and uniformity by discussing practices that have been found acceptable (or unacceptable). Simultaneously, one must recognize that for cleaning validation, as with validation of other processes, there may be more than one way to validate a process. In the end, the test of any validation process is whether scientific data shows that the system consistently does as expected and produces a result that consistently meets predetermined specifications.

This guide is intended to cover equipment cleaning for chemical residues only.