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About Us

GMP TRENDS  was founded because, as quality professionals, we recognized the need for an unbiased editing of all relevant FDA 483's. Over our 30 years of providing this information, we have seen our readership grow to encompass thousands of subscribers in over twenty countries, all working toward a common goal of improving quality systems, thereby preventing GMP issues before they occur. Our Editors and Advisory Team are dedicated to bringing you the information you need in a timely fashion, twice monthly, so that you can remain in compliance.


ABOUT THE NEWSLETTER
Would a newsletter that edits and presents current and relevant FDA 483 observations be valuable to you? GMP TRENDS  is exactly that.

The GMP TRENDS  newsletter is unique in many ways:

  • See it from the inspectors viewpoint without any third-party commentary or interpretation
  • Interpret the relevant 483's as they apply to your facility and spot vulnerable areas before they become an issue
  • Tighten up your QA process and enhance compliance training
  • Educate your team about new and ongoing inspection issues
  • Only significant observations are included to save you time
  • Includes global inspection information
  • Available in print, on the web or both, delivered twice per month
  • Archives available so that you can observe trends in inspection observations

How do we provide you with this valuable information?
Our editors review all FDA 483's issued by the FDA as soon as they become available, eliminate insignificant and irrelevant information, and publish significant observations made by FDA investigators during plant inspections throughout the world. These significant and relevant observations are reprinted verbatim without editorial comments. This allows you and your staff to interpret these observations as they pertain to your facility and procedures.

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