NNE is providing a number of services as part of the expansion of Sanofi Pasteur’s vaccine facility in Shenzhen, China.
Sanofi Pasteur has been operating in China since 1996 and is currently marketing six different products in the country. However, only one is fully produced in China. Currently, these products are sold to the private market, but Sanofi Pasteur is looking to access the public market. Sanofi Pasteur has to comply with Chinese GMP and pharmacopoeia, which has more stringent requirements than those of other countries.
In South China, NNE played an important role assisting in the development of Sanofi Pasteur’s vaccine facility in Shenzhen. The facility has been built in two stages: firstly as a greenfield facility from 2008-2010 that was GMP certified in 2013, followed by an expansion for filling, finishing and packaging activities.
NNE has helped us in many ways, and when it comes to commissioning and qualification services, I personally believe that they are a partner of choice for this kind of service in China.
In the vaccine facility, a number of NNE employees have been involved in a variety of supporting tasks for years, including training local suppliers to meet international requirements, managing contractors and providing services within commissioning and qualification.
NNE quality manager Lily Zhang has worked closely with Sanofi in many projects since she got involved in the first one in 2009, where she took the role as lead quality engineer. NNE was responsible for the preparation of validation plans, installation and operational qualification (IQ/OQ) protocols for clean utilities (purified water, water for injection, pure steam) and sterilization autoclave, site acceptance test support and IQ and OQ test execution. NNE was also in charge of IQ/OQ review and support for the execution management system.
Lily Zhang explains that NNE over the years has built up a deep knowledge and understanding of Sanofi Pasteur’s validation concept:
“Compared with international suppliers, some of the local suppliers working together with Sanofi have less experience and might not be as familiar with what the expectations are and what they can and cannot do. At NNE, we have that knowledge and experience, and through training, we can help the local supplier improve their competencies. It is a win-win situation because the suppliers also see it as a chance to increase their quality,” says Lily Zhang.
“We have a very good collaboration and have worked with NNE for years,” says Cedric Dubois, head of industrial operations China for Sanofi Pasteur, the vaccines division of Sanofi. “The services have mainly involved construction, start-up, commissioning and qualification support. NNE has helped us in many ways, and when it comes to commissioning and qualification services, I personally believe that they are a partner of choice for this kind of service in China.”
NNE continues to have a presence on the Sanofi site and provide services within commissioning and qualification.
2008 – ongoing
Supervision of the turnkey vendor during construction, commissioning and qualification.
Execution and supervision of installation qualification (IQ) operational qualification (OQ) testing.