Vincent Langlade

ISO 15378 sertification for all SGD Pharma Plants/GMP/New developments
Vincent Langlade, Marketing Director Pharmaceuticals, «SAINT-GOBAIN DES JONQUERES», France

SGD : leader in glass manufacturing

In a process of continuous improvement, the R & D team of SGD Pharmacy focuses on:

• glass melting, process and analysis
• glass control stations
• improvement in pharmaceutical glass qualities

As a result of improvement in pharmaceutical glass performances, Asolvex®, the unique type I glass with a low aluminum level has been developed.

Creativity New designs and security for users

Thanks to its pharmaceutical glass expertise, SGD is striving to develop new designs in every type of glass, color or quality level. We develop our packaging solutions responding to specific needs, such as Mix o Vial®, a bottle with a dual chamber design, or U Save®, U-shaped bottle for a complete liquid delivery.

Personnalization & Security Trough plastic coating & printing

Plastic coating consists of a thin and protective film of plastic on the bottle; such coating is requested by EU regulations for aerosol bottles. Plastification used as protection against mechanical shocks, offers security to the user in case of breakage. All colors and aspects like glossy, matte, frosted, clear and opaque are available. With or without a plastic coating, our bottles can be decorated with serigraphy using UV ink, at the Verreries de la Somme, the printing plant of SGD. So, our bottles while preserving the intrinsic qualities of glass, improve your pharmaceutical product image, highly important for OTC and generics.

SGD becomes First Pharmaceutical Glass Manufacturer in the world to achieve ISO 15378 Accreditation for all its production facilities.

SGD’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 last year certification of our plant of Kipfenberg, Germany.

The Kipfenberg plant was 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 SGD 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 SGD’s already robust quality system with GMP principles. SGD has always been an industry leader in innovation with its class 100,000 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.

Consistent with the strategy of specialized production sites, SGD assumes the leadership role in fixing ISO 15378 as the norm for all its pharmaceutical glass manufacturing sites. Being the first pharmaceutical glass producer to achieve the standard at all sites exemplifies SGD’s commitment to the pharmaceutical industry.

The investment and efforts required were significant and the success is a result of great teamwork, synergy and collaboration between all sites.

This certification confirms the full commitment of SGD to patient safety.