Pharmaceutical Manufacturers have to consistently achieve a high standard of product quality. A well-planned and effective cleaning process plays a very important role in this by eliminating contamination & cross-contamination. A documented evidence is required to prove that the cleaning methods in place are consistent and in line with cGMP requirements. Ineffective cleaning processes can, not only lead to more batch failures but also result in FDA 483s and warning letters.
The last few years have seen the regulators increasing the amount of interest and scrutiny for cleaning validation during inspections. FDA inspectors now want to see a functioning cleaning validation program with appropriate documentation in place during their inspections. Let us try to understand where the gap lies, between the regulator's expectations and the pharma companies, which is leading to an increase in citations relating to cleaning validations.
Adoption of technology is currently picking up pace in the