Did You Know?
During 2010, the FDA performed a large number of regulatory inspections and has compiled a list of the most common deviations found. According to www.labcompliance.com, 19 percent of the devations found on the list were "related to unvalidated lab test methods," and that "laboratory controls [issues] ranked as number 1." Additional data points of interest also include quality system and production process control systems which rank at 9 percent and 6 percent respectively. Also according to labcompliance, it was found that lab control deviations were found to be highest in China (at 28 percent).
To learn more, attend the Lab Compliance audio seminar "Learning from Recent Warning Letters Related to GMP Laboratory Controls"
and get 20 examples of FDA warning letters.