Latest Trends in cGMP Compliance

Latest Trends in cGMP Compliance

September 3rd, 2013 // 3:46 pm @

Latest FDA and cGMP Compliance News

Here are some current cGMP compliance trends we are hearing from some of our industry contacts.

  • We are seeing in the last year or two an emboldened FDA, which is trying to measure up under a Congress more interested in food and drug safety. For example, we have seen 16 major pharmaceutical consent decrees from 1989 to 2012, and what do they all share? All of them had major cGMP violations. And only a total of six of them were eventually vacated.

Eric Blumberg, chief deputy counsel for litigation at FDA, has said for over a decade that the agency cannot make a lot of progress with major cGMP violations until individual people are charged with criminal conduct. We are starting to see this happen – Marc Herelin from KV; W. Harkonen from Intermune; Lauren Stevens from GSK.

Also in this area, the new FDA commissioner, Margaret Hamburg, has stated that FDA is not going to issue multiple warning letters any more for major cGMP flaws. No, they are going to be developing criminal cases against certain individual executives at pharma companies with repeated, major violations.

  • When there are repeated cGMP violations in the same area, FDA is now going to question the willingness of Quality to do its job. Repeated 483s are going to be considered a quality unit failure. Warning letters noted that quality unit failures can be attributed to unwillingness to do the job, or an inability because of a lack of independence from higher up’s. Many recent high profile cGMP cases often have ineffective quality units.
  • FDA is expecting that the global deployment of quality management system be overseen by corporate management. Corporations will be expected to have total oversight of the regulatory and quality compliance of the operation units under their purview. Some firms are flattening their facilities into non compliance and poor oversight because of highly questionable advice of cost-reduction and efficiency experts. Also, the Park Doctrine is going to hold upper management responsible, even if they were not aware of major cGMP violations. Some of these people have had to appear before Congress, so be aware!

Do you want to learn more of the latest cGMP, warning letter and 483 trends? Then please review our upcoming webinar, Top Compliance Trends for 483s and Warning Letters for 2013.


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