End of 2009 gemro and its GMP experts were invited by the Chinese SFDA to join several GMP workshops and to discuss with more than 150 SFDA GMP experts and inspectors about international GMP requirements. Main focus was on inspections and inspection practices by US FDA and European authorities. Also new western GMP trends were highlighted. The objective of the workshops was to analyze the still existing differences between Chinese and Western GMP and to find a way to help Chinese manufacturers to come closer to meeting international standards.

Ira Berry, the US based gemro associate and US representative explained in detail how the US FDA is preparing and carrying out onsite inspections. He introduced the FDA’s Compliance Program Guidance Manual for drug plant inspections (CPGM 7356.002) and discussed in detail the 6 systems procedure (s. figure 1). “Minimum 2 of the 6 systems are subject to inspections whereas important topics like training, documentation, validation, and CAPA are always on the schedule” – Ira explained. Based on his many years of experience and his close cooperation with the US FDA, he provided many case studies and made clear that in most cases there are weak points. So the handling of OOS (Out of Specifications) together with the very often missing OOS log are a number one concern during those audits and inspections. Missing or not adequate validation activities and missing process understanding are other typical concerns found often for Chinese manufacturers.

Ralf Gengenbach, managing director of gemro, with over 20 years in the field of GMP, and having at least 10 years of experience with Asian drug manufacturers covered the topic EU GMP and EU relevant inspections. He explained the EMA (former EMEA) inspection procedure (EMEA/INS/GMP/313513/2006 Conduct of Inspections) and went into details of the relatively new PIC/S inspection guidelines. “For sure it is not easy to understand and follow all of these national and international GMP guidelines. Anyway – 316 finished product and 119 API inspections executed between 1995 and 2005 only by European authority show the increasing pressure on pharmaceutical manufacturers and the need to follow those regulations”. Further on Ralf pointed out “Indeed the general situation in China regarding GMP compliance is becoming better in recent years but still missing are many details to satisfy western inspectors”. Ralf went on by presenting a lot of questions from real western GMP inspections explaining on what is behind and expected by western inspectors.

Finally the topics: Process Understanding, Risk Analysis and Risk Management, Quality by Design, and Quality Management as well as CAPA (Corrective Actions Preventive Actions) were outlined as the actually discussed new GMP trends in the western world.

To provide this expert knowledge to the public gemro will organize a special seminar on EU/US GMP compliance in November in Shanghai. For more information please contact Cobby Zhang on c-zhang@gemro-services.com or on phone: +86 20 8736 5457.

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