Contamination Control

Published: 1-Aug-2011

21 - 23 March 2012
Budapest, Hungary

In most cases the implementation of appropriate hygiene programmes and measures have been implemented as an essential part for the manufacturing of pharmaceutical products. A series of regulations address the subject of microbiological facility control but GMP requirements are mostly described in more general terms. And, inspection findings demonstrate the lack of control of microbiological contamination.

Between 1995 and 2005, the potential risk of microbiological contamination was the No 2 critical GMP deficiency and the No 1 major GMP deficiency observed during inspections requested by the CHMP/CVMP of EMA.

Now, how can GMP requirements be introduced in pharmaceutical companies in a practice-oriented way? What is state-of–the-art? How should detergents and disinfectants be used?

The overall goal of such a system is to prevent microbiological contamination of the pharmaceutical product. But even if such a system has been established, it is of utmost importance that these programmes and measures are understood and followed by all operators who carry out quality-relevant work. Therefore, regulations demand intensive training in hygiene issues.

Against the background of these requirements, this ECA education course is designed to cover all important aspects of controlling microbiological contamination. It ranges from sources of contamination to validation of cleaning and disinfection processes and training of operators. A focus will be on those problems that occur frequently in pharmaceutical production; possible solutions to these challenges will be discussed

Organiser: European Compliance Academy

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