It is important to ensure that a reserve sample representative of each lot or batch […]
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 TrendsĀ® 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.
According to the Code of Federal Regulations (CFR) section 21 CFR 820.50 Purchasing Controls each […]
Manufacturing quality products requires using raw materials that meet your quality standards. According to the […]