14 years in the making, EU GMP Annex 1 has finally been published! The document covering "The Manufacture of Sterile Medicinal Products" made its debut on 22nd August 2022. "While it's not perfect it's now out there. The challenge is now how best to apply it as the goal is to improve product quality and ultimately patent safety and wellbeing," said 3idimenstion Cleanroom's Principal Consultant, Conor Murray. Manufacturers do not need to panic though, the new standards from the European Commission will not come into effect until August 2023. And if you are focused on the frequency of sterilisation of lyophilisers (point 8.123), there is an extra year on top of that.
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