GMP Sites in China and India: A Comparison
[Posted on: Thursday, 11 February, 2016]

Last week we discussed the similarities and differences between pharmaceutical GMP sites located in China and India with regards to compliance with FDA requirements. This week the Regulatory Affairs Professionals Society (RAPS) published a much more detailed comparison from a different perspective, the review of a few FDA 483s issued to Chinese companies in 2015. Overall country-wide quality of GMP compliance can be measured using two methods, review of FDA’s inspections database (like we did last week), and the review of the FDA 483s that give a  much deeper look at the specific findings (like the one by RAPS). There are several interesting observations. FDA conducted about 50% more audits in India compared to China in the year 2015, 132 in China verses 203 in India. The number of inspections stayed similar in China over 2014 and 2015, while those in India practically doubled between 2014 and 2015. The number of inspectors is similar in both countries; 8 in China and 9 in India, and in both countries FDA expects to double the respective number of inspectors. China has about 700 FDA-registered facilities to 500 in India. Both countries have similar number of sites banned from exporting to the US; 42 in China and 41 in India. Interestingly, in the sample of 8 FDA 483s reviewed by RAPS (out of 80 issued), common observations were related to data integrity issues, similar to those observed at Indian facilities. Other observations were related to facility maintenance, contamination, and documentation practices, again similar to findings in India. It appears that sites in China are similar in most aspects to those in India such as frequency of audits by FDA, number of sites in findings, and kind of observations. However, it may not be that simple. Based on personal experience and the feedback we received last week from our readers, China has made significant improvement in its GMP regulations and their enforcement while Indian GMP rules have remained unchanged despite the wide-spread negative publicity. On the other hand, Indian sites are more accessible than those in China, in terms of easier visa for FDA auditors and use of English in all documents. It would fair to say that there is no fair comparison and that a given GMP site in either country must be evaluated on its individual merits. Due diligence inspections must be critical before selection of vendors in either country. There are no simple answers, if you were looking for one, you are not going to find them here.