28th of February 2018

GMP new Annex 1 draft

The new Annex 1 draft of the EU GMP guideline "Manufacture of Sterile Medicinal Products" was published on 20th of December 2017 and is still under discussion until 20th of March 2018. An Annex 1 conference is scheduled on 8/9 May 2018 in Berlin.

Annex 1 has been completely revised in cooperation with the EMA, WHO and PIC/S.

Quality risk management (ICH Q9) is included now and the following changes are made: Completion of new chapters (scope, utilities, environmental and process monitoring sections and glossary), integration of new technologies as well as a restructuring for a better understanding and increased detail level. Valicare GmbH employers are experts for qualification and validation of aseptic lines and processes. They will support you in analyzing and implementing the new requirements.

The new draft of Annex 1 of the EU GMP guideline is available here