SPORE NEWS SN086 – Unveiling Annex 1

SPORE NEWS SN086 – Unveiling Annex 1

Navigating Compliance for Users of Mesa Labs Biological Indicators

On 25 August 2023, Annex 1 of The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use¹ becomes effective. The annex specifically covers Manufacture of Sterile Medicinal Products and replaces a previous version of the document which was in place since March 2009. The purpose of the update is “to reflect changes in regulatory and manufacturing environments and to remove ambiguity and inconsistencies and will take account of advances in technologies.” The new version is approximately three-fold longer than its predecessor, much of which is regarding the equipment used in aseptic preparation and processing.

Access the whitepaper now and unlock the key to Annex 1 compliance excellence by downloading document HERE.