Annex 1 Compliance Guidelines For Biological Indicator Users

By Crystal Hostler

On August 25, 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 Use became 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.

Here, we delve into the crucial topic of Annex 1 and provide valuable insights into its impact on your industry. Gain a deeper understanding of the requirements, guidelines, and best practices for compliance whether you're in pharmaceuticals, healthcare, or any field utilizing biological indicators.