Saint-Gobain DesjonquEres's French production sites at Mers-les-Bains, Sucy-en-Brie and Verreries de la Somme have achieved ISO 15378 certification.
Last year the company's plant at Kipfenberg, Germany, became the first primary packaging supplier in the world to achieve this standard. Now the addition of the Mers-les-Bains and Sucy-en-Brie sites makes Saint-Gobain DesjonquEres 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). ISO 15378 is the first ISO standard to incorporate GMP into its requirements.
The company says it has always been an industry leader in innovation with its class 100,000 cleanrooms, 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.