As of March 23, 2017, FDA’s Office of Manufacturing Quality in the Center for Drug Evaluation and Research (CDER) has released 17 Warning Letters, almost all of which targeting manufacturing sites abroad.

Although it’s too soon to tell if this trend reflects a shift toward increased foreign FDA inspections, it should be a stark warning to all pharmaceutical companies with manufacturing sites and/or contract manufacturers outside of the U.S. that foreign compliance should be a serious area of concern.

Of the Warning Letters issued so far this year, most of the issues cited in them occurred in 2016. More importantly, nearly all of them cite violations of current Good Manufacturing Practices and adulteration of drug products.

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The differences between Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) aren't always obvious. Both share similar terminology and at times, somewhat similar applications.

But for those who apply these practices, or collaborate with those who do, the differences are important. Confusing one for the other can lead to serious compliance problems and rework.

This guide offers a quick and simple explanation of the differences, starting with the most pronounced.

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No matter how confident you are in the current state of your QMS, the next three years will challenge even strongest quality systems.

New international regulatory demands––ISO 13485:2016 and The Medical Device Single Audit Program (MDSAP)––both require an even tighter grip on quality management processes. 

These new rules and revisions stretch throughout the QMS, especially for those managing large networks of suppliers and vendors. Document management, change control, supply chain, product lifecycle, as well as device usability and postmarket surveillance requirements will all be affected. 

To give you an idea of what’s coming, we’ve summed up the key takeaways medical device companies should be aware of regarding these new rules.

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