“Cleaning, how hard can that be,” is the sentiment of those not in the bio/pharmaceutical industry. Even for those within the industry, the general consensus regarding Cleaning and Cleaning Validation is that it is something best avoided and that once it is done, it is best forgotten. No one wants to relive that nightmare. But the reality of the New Process Validation Guidance from the FDA means that the industry needs to verify, control and improve previously completed cleaning process validations.
Certainly cleaning is a science that has been practiced in numerous industries for many years, but no other industry is more greatly impacted by critical process cleaning than that of the bio/pharmaceuticals. Clearly the repercussions of residuals and cross-contamination may have very real consequences on lives and corporate profitability. The importance and impact of cleaning and its documented cleaning validation have been clearly stated in numerous government regulations, industry articles and community conferences. Those vehicles have established minimal expectations and explored facets of cleaning validation programs’ improvement.