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In the Pharmaceutical Industry there is some possibility of contamination and cross-contamination of products due to inadequate washing of shared facilities. This can lead to severe hazards for the patient, therefore any contamination as well as cross-contamination cannot be afforded in (imagine, for instance, what would happen if a drug for a trivial headache contained a narcotic drug instead…!).
Pharmaceutical products can be contaminated by various materials such as residues of previously used active pharmaceutical ingredient (API), raw materials, detergents, dust particles as well as microorganisms, pyrogens and endotoxins. This is the reason why an efficient cleaning of surfaces is a relevant and fundamentally important aspect. But…what’s the “Cleaning” meaning? “Cleaning” means making any article, piece of equipment and area free from product residue, dirt, marks, any unwanted matter and microorganisms.
The risk of contamination and cross-contamination can be minimized by applying suitable cleaning procedures to equipment, apparatus and processing areas. The Pharmaceutical Industry wants to achieve these main goals with the help of current Good Manufacturing Practices (cGMP). In fact, the main goal of cGMP is the prevention of products contamination and cross contamination through the implementation of an appropriate and validated cleaning program. This “program” is known as “Cleaning Validation” and can be defined in a few words as the documented evidence that cleaning procedures applied to equipment, piece of equipment or systems will obtain pre-established acceptable limits.
Nowadays, the main regulations and guidelines governing Cleaning Validation comes from Authorities like EMA, FDA, APIC, PIC / S and WHO. An important turning point came in 2012 with the introduction of the EMA/CHMP/CVMP/SWP/169430/2012 (operative since 2014, after a couple of years of adjustment), which first introduced the concept of “chronic toxicity” (PDE) in the risk assessment of the chemical cross-contamination. In the wake of the EMA, the FDA (Validation of Cleaning Processes (7/93), 2014) and WHO (Working document QAS/20.849, 2020) also aligned themselves in the following years with harmonized regulations on Cleaning Validation based on substances’ toxicity.
At this point the role of Cleaning Validation in the Pharmaceutical Industry should be a little bit clearer than before and we could try to explain the Cleaning meaning through “5 Ws”…
