Mar 31 2010
Intercim, announces that Sanofi Pasteur, the vaccines division of the Sanofi-aventis Group, is accelerating the use of Pertinence Suite, Manufacturing Operations Management (MOM) software solution, within the European and North American sites of the worldwide leader of vaccines.
Vaccines come from complex biological processes. The understanding of such manufacturing process is one of the key elements to master products quality and production units performances. Since 2003, Sanofi Pasteur has used the Pertinence Suite solution to better understand, improve reliability and optimize industrial processes.
Rene Labatut, Vice President Manufacturing of Sanofi Pasteur explains: "Manufacturing, and guaranteeing the highest level of quality and safety for the patient, and the optimum performances for the company, are key objectives of process understanding. It is also a corporate challenge in the current competitive environment. The use of Pertinence Suite for understanding mechanisms which drive our complex processes is an asset that provides answers to this double requirement in an efficient manner".
The new deployment of Pertinence Suite demonstrates the willingness to implement in a very operational manner the approach promoted by the regulatory bodies through the ICH Quality by Design (QbD). This approach aims at mastering manufacturing processes and efficiently, while sharing with the authorities the understanding of the mechanisms which drive products critical quality attributes.
Yann d'Aramon, Director Europe of Intercim adds: "We are very pleased of Sanofi Pasteur decision to spread the use of our solutions through their plants around the world. With our solutions, Sanofi Pasteur can identify and set up in real-time, parameters influencing the product quality, and moving forward, better control process variability. This is a recurrent challenge for the pharmaceutical industry which needs to consistently deliver vaccines on time, with a perfect traceability."