The day has finally come.

The final version of Annex 1 of the EU-GMP  on manufacture of sterile products, under revision since 2017, was published on August, 25^th  2022. Now, it’s time for companies to  implement new/revised requirements before the Annex comes into force on August, 25^th, 2023 (except for a specific point, 8.123 coming into operation  on August, 25^th , 2024)

The overall intent is to ensure safety of the user by preventing the contamination of the medicinal products, giving companies guidance from the design of premises till the release of the batches.

The new annex reflects changes in regulatory, technology, manufacturing methods happened during the 15 years from the previous version. In 2007, for example, ICH Q9 and ICH Q10 were not yet issued, and, since then, many other changes in regulations and GMP were implemented. The new annex takes into account all of these. Greater emphasis on risk management, knowledge management, enhanced process understanding continuous improvement and a holistic view on interrelationships with pharmaceutical quality system are some of the features of this new guideline, together with an effort to remove ambiguity and inconsistencies throughout the text.

The benefits of these changes are then to ensure that pharmaceutical products manufactured in the European Union meet the highest possible quality and safety standards.