Statement on the new GMP Annex 1

Use of safety cabinets for the preparation of parenterals in pharmacies

On 25.08.2022, the final version of the new Annex 1 of the EU GMP Guideline was published. Over several years, the previous version was completely revised in collaboration between the European Medicines Agency (EMA), the World Health Organization (WHO) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Some of the changes have raised the question of whether safety cabinets may continue to be used for aseptic, patient-specific preparation of medicinal products in light of the requirements formulated therein.

In our statement, we explain the new regulations and show why safety cabinets for the preparation of parenterals may continue to be used in pharmacies.