EU GMP Draft Annex 1: Potential impact on cleaning and disinfection

Cleaning and microbial contamination control are critical focus areas in pharmaceutical and medical device industries.

Robust cleaning and disinfection programmes are needed to meet the required cleanroom microbial grades, to prevent cross contamination and subsequent microbial contamination of products. EU Annex 1, which specifies guidance for the manufacture of sterile medicinal products was first issued in 1989 and has not been updated since 2007. With no complete review of the annex having been carried out for over 10 years, a complete review and rewrite was needed.

With over 30 years of experience in developing and manufacturing cleanroom contamination control products, let Contec help lead you through the proposed changes for biodecontamination control in EU GMP Annex 1. This webinar explores all the general changes in the annex, with specific reference to contamination control strategy. The references to cleaning and disinfection have been expanded, and the webinar will discuss this in more detail.

Although the annex is still at a draft stage, and there has been a call for a further consultation phase, there is a widely held view that the general direction of travel shown in the document will not change. It would be prudent to plan ahead with any disinfectant validation with these core principles in mind, as it likely that many will appear in the finished document.