Cleaning validation its requirements and regulatory aspects.
Validation of cleaning process in pharmaceutical manufacturing is important validation process, it is one of the important and mandatory requirement of almost all food and drugs regulatory agencies and FDA’s around the world .In US. The US FDA current good manufacturing practice regulation 1963 says that the ‘equipment must be maintained clean and orderly the main concept behind the cleaning validation is to prevent cross contamination or adulteration of drugs. As even in a very small amount the drug contaminations are likely to produce sever untoward reactions, example penicillin and drugs regulating blood glucose, cardiac glycosides and drugs acting on heart and blood pressure regulation system if contaminated in very trace amounts may result in fatal untoward health events in patients , a drug cross-contaminated with a potent steroids or hormones has very great adverse effect on health of an individual. Many drug products were recalled in past in USA due cross contamination with actual or potential penicillin.
In 1988 a drug product Cholestyramine Resin USP was recalled as bulk pharmaceutical chemical used in the product was contaminated with low level intermediates of a pesticide due to reuse of recovered solvent, since there were no adequate controls over the solvent drums, firm lacked a validated cleaning procedure for process and did not had a cleaning validation in place for the cleaning of solvent drums.
Therefore in FDA inspections special attention is always given on cleaning validation programs at all levels in process beginning from receiving of material, and in all inprocess stages till the finished product. It is required that a pharmaceutical company should not only see absence of previous product, and detergents used in cleaning the equipment in a swab test or in equipment rinse water ( also see water system validation ), rather other aspects which affect cross contamination too are important like using common equipment and arias for processing of drugs with serious health effects if cross contaminated . gmp guidelines
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