In Pharmaceutical Industry cleaning processes have to be designed and carried out in a way that prevent cross-contamination as much as possible. Since most of equipment, apparatus and processing areas (the so called “shared facilities”) are being used to manufacture different products, cleaning processes must be able to remove residues from equipment product contact surfaces up to an acceptable level. In this context, the role of current Good Manufacturing Practice (cGMP) is the prevention of products cross-contamination by apply and validate cleaning programs, which consists in the documented evidence that cleaning processes and procedures applied to shared facilities will obtain residues on equipment surfaces under pre-established acceptable limits.
Starting from the beginning of the new millennium, Cleaning Validations have assumed an increasingly important role in the cGMP field, up to having a further push starting from 2012, with the publication of the EMA/CHMP/CVMP/SWP/169430/2012 draft (effective from 2014), which first introduced the concept of “chronic toxicity” (PDE) applied to cleaning validation. Cleaning Validations have always been a demanding challenge for Pharmaceutical Companies, because they involve a great amount of resources and time to be implemented. In this review we will try to provide a general and clear overview of the Cleaning Validation, through 5 simple questions, the "5 Ws of Cleaning”. So…Let’s see What’s the “Cleaning” meaning!