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EU GMP Annex 1 Update 2008: Airborne Particle Counting

 

Morgan Polen – VP of Applications Technology, Lighthouse Worldwide Solutions. 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).

 

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