CLEANING VALIDATION AND RISK MANAGEMENT
IN MANUFACTURING PHARMACEUTICALS
FORMS WITH POTENT ACTIVITY
MIHAELA BALMOȘ1,2*, MIHAI IOAN LAZĂR1,2, GEORGE TRAIAN
ALEXANDRU BURCEA DRAGOMIROIU3
1SC Fiterman Pharma SRL, Iasi, 127th Str. Păcurari, Iasi
2University of Medicine and Pharmacy „Gr. T. Popa”, Iasi, Faculty of
Pharmacy, 16th Str. Universității, Iasi
3Department of Drug Control, “Carol Davila” University of Medicine
and Pharmacy, Faculty of Pharmacy, 6, Traian Vuia Street, 020956,
Bucharest, Romania
* corresponding author: mihaela.balmos@fitermanpharma.ro
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Abstract:

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.

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