December 2011

Having succesfully completed a number of projects together, including achieving EU GMP certification for their Sterile Cephalosporin fill finish facility in January 2011, the Chinese contract manufacturer Shenzhen Gosun has once again selected TRAQuE as their GMP consultants.

For their newly built sterile API facility Shenzhen Gosun are looking to reach EU GMP standards. After eight hard months the project is nearing completion and the company is putting the finishing touches to their revamped Quality System and refurbished facility. The inspection by Affsaps is anticipated in the next month or two.

Steve Slater has led the project and has been working directly with Shenzhen Gosun in China. He is delighted with the achievements of all those people involved. Reaching EU GMP standards often requires fundamental changes to company systems and procedures but with sufficient effort and the expert guidance that TRAQuE are able to provide, accreditation is achievable.

If you would like further details on TRAQuE capabilities in guiding and assisting companies to achieve international GMP compliance please contact us.