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A focus on data

Regulators got serious with firms that modify manufacturing records

by Jean-François Tremblay
December 5, 2016 | A version of this story appeared in Volume 94, Issue 48

If there was any doubt, regulators in the U.S. and Europe made it crystal clear in 2016 that they are serious about forcing drug manufacturers to maintain the integrity of their manufacturing records.

In August, the European Medicines Agency (EMA) issued a 44-page document that explains to manufacturers the steps they should take to maintain data integrity during the manufacturing, testing, and distribution of their pharmaceuticals. In April, FDA issued a similar document stressing that maintaining data integrity is an integral part of current Good Manufacturing Practices (cGMP), a set of constantly updated drug manufacturing regulations.

In 2016, as they have done for the past three years or so, regulators on both sides of the Atlantic issued warnings against, or even banned, drugs made by companies that falsified data or that didn’t strictly control access to their batch records. The offenses uncovered by regulators varied widely in their seriousness.

At the mild end of the spectrum, Shanghai Desano Chemical Pharmaceutical received a warning letter from FDA for failing to investigate out-of-spec test results and for not documenting the results of some quality tests. At the more serious end, India’s Megafine Pharma was cited after a technician disclosed to an FDA official the outright falsification of data from a drug stability test. Pharmaceutical ingredients produced by Megafine are currently banned in the U.S.

FDA and EMA consider a comprehensive, unfalsified set of manufacturing data to be essential to their ability to assess companies’ compliance with cGMP. Many industry watchers agree.

“ ‘Data documentation issues’ is not the case of a sloppy secretary failing to file test reports alphabetically,” commented Dinesh S. Thakur in an Indian magazine earlier this year. Rather, data are often falsified to show that subpar batches of pharmaceuticals meet quality standards. Now head of Tampa-based Medassure Global Compliance, a consulting firm advising companies on their pharmaceutical supply chains, Thakur was the whistle-blower who alerted FDA in 2007 to endemic manipulation of manufacturing records at India’s Ranbaxy Laboratories.

Others say the emphasis on data integrity can be misplaced. Peter J. Werth, CEO of the Connecticut-based drug ingredients importer ChemWerth, told C&EN this summer that drug quality and data integrity aren’t always correlated. In some cases, he said, technicians understandably delete misleading test data recorded by improperly calibrated lab instruments.

Werth may have a point, but the past year underscored the emphasis regulators place on sound data.


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