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Agnes Shanley is senior editor of Pharmaceutical Technology.
China and India are also increasing inspections and becoming more exigent about data integrity and cGMPs.
China and India are also increasing inspections and becoming more exigent about data integrity and cGMPs. The China Food and Drug Agency (CFDA) has increased its plant inspections from 35 in 2011 to 110 in 2015 says Lewis Ho, a Dechert LLP partner who leads the life scieces practice in Asia.
In India, FDA and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) have been ramping up inspections for data integrity issues, says Hyman, Phelps, and McNamara, PC Principal, Doug Farquhar.In addition, regulators are sharing more information on violating plants, so that if one plant has failed numerous MHRA inspections, FDA will rely on that knowledge. However, notes Mark Schwartz, counsel with Hyman, Phelps, McNamara, FDA inspectors won’t be relying too much, or suspending inspections, based on positive reports from other ragencies.
The CFDA has been learning a lot from FDA, says Ho. “When FDA inspectors come to look at a plant and its operations, a CFDA staffer usually accompanies them to learn and gain more insights into the way FDA handles inspection. There is a lot of exchange of experience going on. And far more inspections are taking place,” he adds. China’s inspectors have taken the message of data integrity very much to heart, Ho says, and are focusing on that and data management, while unannounced inspections have become more frequent, and CFDA recently took away a company’s manufacturing license when it attempted to prevent an inspection.
It is important to get to know any potential business partners based in China, and to understand their compliance practices clearly before working with them. “Inspections can become cultural issues. Many Chinese companies are following the US inspection style, but may still be using Chinese style where enforcement is concerned. In general, they are not used to confrontational approaches, so companies need to send representatives with thorough knowledge of the language and customs, as ‘bridges’ if they are to understand the situation and handle it adequately,” says Ho. CFDA inspectors are also being sent to other countries to handle inspections, particularly in the European Union. Some CFDA inspectors have already issued critical reports.
Article DetailsPharmaceutical Technology
Vol. 40, No. 7
When referring to this article, please cite it as A. Shanley, "More inspections, and reulator collaboration, offshore," sidebar to “Ensuring Supply Chain Safety," Pharmaceutical Technology 40 (7) 2016.