To complement the implementation of the new GMP in China, to exchange and share the experiences and understanding of the domestic and foreign pharmaceutical industry, IPEM 2012 Sterile GMP Risk Analysis Workshop was held by International Pharmaceutical Engineering Management (IPEM) program in cooperation with FDA's China Office at PKU on May 2^nd. The participants included the experts from SFDA and FDA, domestic and foreign companies, and the postgraduate students of IPEM Master's Degree Program. Dr. Gang Wang, assistant country director for pharmaceutical affairs of the FDA China Offices, attended the workshop. The Chairman of Changzhou Siyao Pharmaceutical Co., Ltd, Mr. Yongrui Tu gave the opening speech on behalf of Peking University-Changzhou Siyao Joint  Laboratory of Sterile GMP. Ms. Hua Zhang, the Principal GMP auditor of Shanghai Food and Drug Administration's Center for Certification & Evaluation, and the IPEM'07 Most Outstanding Student, chaired the semi roundtable discussion that was focused on the issues in GMP implementation in manufacturing of sterile pharmaceutical products, including loading and unloading of sterile freeze drying, manual automated operations, laminar flow cart transport, monitoring of clean area, selection of monitoring points, smoke study, and closure test of stoppering and crimping/capping of the vials. Most of the attending experts took part in the compiling of the new GMP Guidance for Sterile Pharmaceutical Products, the case presented by Mr. Tao Ma, the chief quality officer of  Wuxi Sino-Swed Pharmaceutical Group, Ltd., and the experiences shared by the attending experts, sparked a warm and in-depth discussion, and the attending experts and audiences shared their views and experiences.
Dr. Brenda Uratani, former associate director of FDA's China Office, and teaching faculty of the IPEM program, concluded that, she was deeply impressed by the interactive and warm discussion, she was feeling the trend and action of stepping to the international standards by Chinese pharmaceutical industry, and good quality system was not built within a short term, more such workshops should be held . The workshop was co-sponsored by Shanghai Tofflon and Merck Millipore.

The 2nd Edition is an essential guide to preparing for inspections, taking into account current trends in FDA expectations and enforcement activities, such as a quality systems-based approach to inspections, risk-based inspections, and the GMPs of the 21st century to produce rapid regulatory approval.

CPIER has completed the translation of this book and provided it to the industry.

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