21 November, 2023

New EU GMP Annex 1 is applicable as of August 25, 2023!

As of August 25, 2023, the new Annex 1 of EU GMP is now in effect. Annex 1 is a pivotal European guidance document outlining good manufacturing practices for medicinal products.
This annex provides guidance that should be used in the design and control of facilities, equipment, systems and procedures used for the manufacture of all sterile products applying the principles of Quality Risk Management (QMR), to ensure that microbial, particulate and endotoxin/pyrogen contamination is prevented in the final product.
Key principles, including Contamination Control Strategy (CCS), cleanroom classification, premises design, qualification, validation, monitoring, and personnel gowning, can be extended to support the manufacturing of non-sterile products as well.
Notably, the new Annex introduces more detailed specifications for viable and non-viable environmental and process monitoring. This enhanced focus is crucial in developing an effective Contamination Control Strategy (CCS). The Annex aligns with global efforts to harmonize good manufacturing practices, elevating sterile manufacturing to new heights of safety and technological advancement.
At GXP CONSULTING Switzerland, we are committed to supporting our clients through this transition. We offer specialized training sessions on the new Annex 1 and provide gap assessment services to ensure your operations comply with it. If you are interested in learning more or engaging with our experts, please don't hesitate to contact us.