Korrespondenz: Uwe-Peter Dammann, GMP-Beratung, Sprengerweg 15 A, 32760 Detmold (Germany), e-mail:
Over the past twenty years, cleaning validation became an important part of any pharmaceutical activity. Already the “Current Good Manufacturing Practices for Finished Pharmaceuticals” of the American Food and Drug Administration of 1976 as well as European “Principles and Guidelines for Good Manufacturing Practice for Medicinal Products for Human Use” of 1989 laid down the rules to avoid cross contamination, followed in the next years by detailed guidelines for cleaning validation. To minimize and to accelerate the huge amount of cleaning validation, grouping of products and bracketing is very essential. In practice of cleaning validation, grouping on the basis of similar chemical, physical and toxicological properties, similar process conditions of drug substances and drug product have been proved. Risk analysis identifies critical parts of equipment. The basis for cleaning validation is qualified equipment and validated analytical methods. The limits for residues of active substances and detergents should be calculated on a scientific basis. The guidelines for cleaning validation are harmonized widely worldwide.
Key words Grenzwerte • Kreuzkontamination • Reinigungsmittel • Reinigungsvalidierung • Reinigungsverfahren • Validierungsplan
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