In a recent 483, a relabeler was cited for failing to have lot numbers and […]
Achieve Compliance Confidence with GMP Trends
Our reports provide the information you need to stay in compliance.
Welcome to GMP Trends
GMP Trends® was founded in 1979 on the bold idea that empowering pharmaceutical and medical device professionals with clear and concise compliance information could support a higher caliber of product quality: industry-wide.
Since then, we have tracked enforcement trends and simplified FDA’s chaotic mess of 483’s through our reports- saving you time so you can best serve product quality and patient safety. Our reports provide relevant, real-time, unbiased information derived from actual U.S. FDA inspections.
For over 45 years, we have supported thousands of Quality, Regulatory, and Manufacturing Professionals in achieving Compliance Confidence.
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Our Mission
Support the Quality, Regulatory, and Manufacturing community in achieving Compliance Confidence.
Our mission is to equip our clients with the clear and concise information necessary to be compliant with FDA's most recent cGMP expectations, thus enabling the production of the highest quality pharmaceutical and medical devices in the world.
The Twice-Monthly Trends Report
Our Twice-Monthly Trends Report saves time and supports compliance efforts by integrating information on frequently cited FDA 483 observations taken from recent FDA Inspections into one clear and concise report. It is one streamlined report that helps guide your compliance efforts every two weeks.
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Sent out twice a month, our Newsletter is an expansion of one facet of our most recent Twice Monthly Report. Our Newsletter is a free resource we are proud to provide to the Quality, Regulatory, and Manufacturing community as an effort toward our goal of equipping the community with Compliance Confidence. Sign up today to get our Newsletter in your inbox twice a month to support the improvement of your systems.
A medical device firm recently received a 483 from FDA for failing to integrate their […]
Recent 483 observations make it clear that FDA expects a “Belt and Suspenders” approach when […]