IPEC e-newsletter - Excipients Insight September 2016 - 30-09-16


Inside this issue


IPEC Association (China) Ltd joins EXCiPACT

The IPEC Association (China) limited has recently become the fifth member of EXCiPACT asbl - the independent, voluntary third party GMP/GDP certification program for manufacturers and distributors of pharmaceutical excipients. It joins the four founding members - IPEC Europe, IPEC Americas, FECC, and PQG (UK).

IPEC Association (China) was inaugurated in July 2008 to be the voice for the manufacturers, distributors and users of pharmaceutical excipients in China. Presently there are 34 members including both local and international pharmaceuticals excipients suppliers. They have made good progress in developing their relations with the Chinese authorities at both national and local levels and, in recent years, they have been assisting EXCiPACT in raising its profile in this strategically important pharmaceutical raw materials global supply base. This has resulted in EXCiPACT agreements with two international Certifying Bodies - BV China and SGS Asia/Pacific - to provide the EXCiPACT Certification Scheme in the region. EXCiPACT certifications have been awarded by BV China in 2015 to Boai NKY Pharmaceuticals Ltd in 2015 and by SGS to Nanjing Duoyuan Biochemistry Co., Ltd. More are expected this year and beyond as local suppliers realise its benefits in reducing their audit burden and demonstrating to customers their high quality manufacture and supply.

Kevin McGlue, President of EXCiPACT, comments that "The EXCiPACT organisation is extremely pleased to welcome IPEC Association (China) as a full member. They have given great assistance to EXCiPACT as we have sought to establish certification capabilities in the region, and they will now help shape and drive our future plans there. This truly marks EXCiPACT as a globally recognised standard for excipients."


EXCiPACT will be attending this year’s CPhI Worldwide exhibition in Barcelona from 4-6 October. Meetings have been arranged with prospective Asian, US and European pharma excipient manufacturers and global pharma companies to discuss the benefits of EXCiPACT certification. The organisation is now in a much better position to promote its certification scheme in Asia and the USA given the increasing availability of fully registered EXCiPACT  auditors and certifying bodies in these regions.
14 EXCiPACT certificates have so far been issued in 2016 making it the scheme's best year yet and more are expected by the year end. To date, 40 certificates have been awarded in total from pharma excipient suppliers in China, Europe, India, North America, the Middle East and Singapore.




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