Romanian Society of Pharmaceutical Sciences
 

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CLEANING VALIDATION AND RISK MANAGEMENT IN MANUFACTURING PHARMACEUTICALS FORMS WITH POTENT ACTIVITY

MIHAELA BALMOȘ1,2*, MIHAI IOAN LAZĂR1,2, GEORGE TRAIAN ALEXANDRU BURCEA DRAGOMIROIU3

1.SC Fiterman Pharma SRL, Iasi, 127th Str. Păcurari, Iasi
2.University of Medicine and Pharmacy „Gr. T. Popa”, Iasi, Faculty of Pharmacy, 16th Str. Universității, Iasi
3.Department of Drug Control, “Carol Davila” University of Medicine and Pharmacy, Faculty of Pharmacy, 6, Traian Vuia Street, 020956, Bucharest, Romania

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Cleaning validation in the manufacture of pharmaceutical forms is a critical step in implementing the rules of Good Manufacturing Practice (GMP). This process is very important because a drug may be contaminated with dangerous substances. In this paper we validated the cleaning process of the production equipment in the technological process in which we obtained two semisolid topical anti-inflammatory drugs with different pharmacological activity, a topical non-steroidal anti-inflamatory drug (NSAID) (phenylbutazone) and an active potent steroid (clobetasol propionate) on the same production line, without compromising safety, quality and effectiveness, without the risk of cross contamination, ensuring quality production of both drugs. Research can then be put into practice in the pharmaceutical industry for the manufacture of drugs with potent activity in the same facilities and can be extrapolated to other drugs belonging to the same class.