In most cases, the implementation and execution of appropriate hygiene programmes and measures is an essential part of the manufacture of pharmaceutical products. A number of regulations deal with the subject of microbiological operational control, but often the GMP requirements are rather general. But how can they be implemented in pharmaceutical companies in a practical way? What is the state of the art? How should cleaning agents and disinfectants be used? What does a contamination control strategy look like?

The overriding aim of such a system is to prevent microbiological and particulate contamination of the pharmaceutical product. But even if such a system is established, it is of the utmost importance that these programmes and measures are understood and followed by all employees who carry out quality-relevant work. This is why the regulations require intensive training in hygiene issues.

And in the new Annex 1 of the EU GMP guidelines, the overarching integration of the individual measures with the contamination control strategy is now also clearly required.

Against the background of these requirements, this ECA training course is designed to cover all important aspects of microbiological and, to a lesser extent, particulate contamination control. It ranges from the sources of contamination to the validation of cleaning and disinfection processes and the training of operating personnel. Emphasis is placed on the problems frequently encountered in pharmaceutical production and possible solutions to these challenges are discussed.

The course ranges from legal requirements and microbiological principles, sources of contamination, hygiene measures and monitoring to life cycle management of the overall strategy.