The QMN Weekly Bulletin

Report: Surge in Data Integrity Issues Linked to Increased FDA Inspections

May 6, 2016

There is a strong correlation between a surge in warning letters over data integrity issues and increased FDA inspections of manufacturers in India and China — one that could cause production headaches for U.S. drugmakers partnering with these facilities.

That’s the conclusion of a report unveiled March 24 from PricewaterhouseCoopers’ Health Research Institute that shows that the number of warning letters involving data integrity issues has soared since 2010, with only one issued that year versus 10 in 2015.

The report notes that an overwhelming majority of these are going to foreign facilities: 28 of the 29 warning letters citing data integrity problems that were issued between 2010 and 2015 went to non-U.S. companies. Of those, 18 went to companies in India, six to Chinese manufacturers, two to Italian companies and one each for manufacturers in the United Arab Emirates and Thailand.

This glut of data integrity issues comes despite the relatively low number of overseas FDA inspections. The report states that of the 11,878 agency inspections of drugmakers conducted between 2008 and 2015, less than 10 percent of those were overseas (5.4 percent in India, 3.75 percent in China).

The report suggests that passage of the Food and Drug Administration Safety and Innovation Act in 2012 could be a major factor, owing to its expansion of the agency’s inspection powers and authority over imports. It notes that since the law’s passage, the number of warning letters concerning data integrity have shot up 380 percent.

This trend could well increase as the agency continues to expand its overseas presence. The report recommends that U.S. drugmakers doing business with foreign manufacturers protect themselves by conducting global audits of all overseas subsidiaries or business suppliers “to ensure their supply chains adhere to data integrity principles and practices.”

It also suggests that companies employ stronger technological safeguards to prevent data from being compromised, such as unique log-in information for all users and a data audit trail. Further, companies that are worried about data integrity issues should look for unexplained trends in their data, such as one employee always recording the same results or batch acceptance rates that peak just before a shift change.

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