Contamination Control Strategies Requirements, Measures and Strategies

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. But how can they 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.

And in the new Annex 1, the overarching interlinking of the individual measures is now also clearly required with the Contamination Control Strategy.

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.

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

In pharmaceutical manufacture, cleaning and disinfection and other hygienic measures are important and decisive process steps for fulfilling the quality requirements on the medicinal product. To carry them out properly, personnel needs to be both qualified and motivated.

All national and international pharmaceutical GMP regulations — especially those on sterile manufacturing — call for cleaning and hygiene programmes in the pharmaceutical companies.

The lack of control of microbiological (and other) contamination is an outstanding integral part of inspection findings.

Not all authorities regularly publish overviews or inspection results, but if one looks at the available data of the last 20 years from various inspection authorities, the following picture emerges:

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 EMEA.

MHRA’s review of the deficiencies 2011/2012 issued 57 deficiencies related to personnel as well as 75 contaminations by chemical/physical and microbial causes.

In 2018 and 2019, Annex 1 was the second most frequently mentioned annex of the GMP Guide when it came to deviations in MHRA inspections.

A permanent high number of FDA warning letters with microbiological deviations or issues in cleaning and contamination control: