…and its implications for qualification measurement and monitoring

What is Annex 1?

The manufacture of sterile medicinal products is subject to strict specifications, which are defined, among other things, in the EU GMP (Good Manufacturing Practice) guidelines. To take account of current regulatory and technological developments, the European Commission recently updated part of this guideline: Annex 1 „Manufacture of Sterile Medicinal Products“.

Does this have an effect on cleanroom operators?
Yes, because the new Annex 1 (2022) contains, among other things, changes in cleanroom qualification and cleanroom monitoring. For example, the planning and implementation of qualification steps are now more clearly specified. „Free testing“ after realization should no longer exist – but a procedure based on a risk-based approach instead.

The new Annex 1 will take effect with a transition period on August 25, 2023.

We have already informed our customers in detail about the changes resulting for them from the new Annex 1.

Published: March 2023