The Annex 1 is the primary document governing a guidance to how sterile products should be produced and its purpose is to ‘prevent microbial, particulate and pyrogen contamination in final product’. These principles can also be applied to other products such as certain liquids, creams, ointments, etc, where control and reduction of contamination is important.
The current EU GMP Annex 1 revision is the first major revision since 2007, no significant changes have been made since 2009. In December 2017 a draft was sent out for review. This document is due around summertime 2022.
The resulted product has now expanded from 15 to 57 pages and includes new topics like; Quality Risk Management (QRM), disinfectant qualification for cleanroom surfaces and local isolates identification. Especially subjects like monitoring, qualification, validation, and trending are announced in the new Annex 1, which translates into having a more structured approach to the QRM for your production facility.
In the upcoming weeks we will keep you posted as more details will be shared. Contact us for more information on how these new guidelines will impact your business.