THE PARTICLE COUNT NEWSLETTER – AIRBORNE PARTICLE COUNTING FOR PHARMACEUTICAL FACILITIES; EU GMP ANNEX 1

On February 14th, 2008, The European Commission updated Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products. This update comes into operation on March 1st, 2009. (With the provisions on capping of freeze- dried vials implemented by March 1st, 2010)