ICH guideline Q1A(R2), states that “the purpose of stability testing is to provide evidence on […]
Stay in Compliance with Help from GMP Trends
We provide insight on the latest FDA-483 observations. Our reports are filled with the knowledge you need to stay compliant.
Welcome to GMP Trends
GMP Trends® was created to provide relevant, real-time, unbiased information derived from actual U.S. FDA inspections. We obtain immediate access to all FDA inspection information on a real-time basis. We de-identify product and company information to distill the observations into a more readable format. We track enforcement trends and publish periodic reports on a diverse range of GMP topics. Over our 40+ years of providing this information, we have seen our readership grow to thousands of subscribers across the globe.
Our Mission
Our mission is to provide our clients with the knowledge 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.
Relevant, Real-Time Unbiased Information
Our mission is to provide our clients with the knowledge necessary to be compliant with FDA's most recent expectations thus enabling the production of the highest quality pharmaceutical and medical devices in the world.
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The Bi-Monthly Trends Report
Our Bi-monthly GMP Trends Report gives our readers the most frequently cited FDA 483 observations taken from recent FDA Inspections. The non-essential information is redacted to streamline the facts in an easily readable format.
Line clearance is an integral part of every facility’s standard operating procedure in order to […]
According to the Code of Federal Regulations (21 CFR 211.42 Design and Construction Features), any […]