Saint-Gobain Desjonquères's French production sites at Mers-les-Bains, Sucy-en-Brie and Verreries de la Somme have just been certified as compliant to ISO 15378 by AFAQ. This follows certification in 2006 of the plant of Kipfenberg, Germany. The Kipfenberg plant was the first primary packaging supplier in the world to achieve the standard. Now the addition of the Mers-les-Bains and Sucy-en-Brie sites makes Saint-Gobain Desjonquères the only pharmaceutical glass supplier in the world to obtain the standard at all production sites. ISO 15378 is a new standard published in March 2006. It was specifically developed for suppliers of pharmaceutical primary packaging via collaboration among the world leading Pharmaceutical Laboratories. It addresses the demanding requirements of the pharmaceutical industry and defines a quality management system which combines ISO 9001:2000 and cGMP (current Good Manufacturing Practices). GMP has long been the reference standard for the pharmaceutical industry. ISO 15378 is the first ISO standard to incorporate GMP into its requirements. Adopting the standard and achieving certification were key objectives in 2006. The standard reinforced Saint-Gobain Desjonquères's already robust quality system with GMP principles. Saint-Gobain Desjonquères uses class 100000 clean rooms, ISO 15378 focused awareness and discipline in the areas of contamination risk control and cleanliness, validation protocols, product identification and personnel training in GMP practices.
