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.

Celebrating

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years of trending trusted compliance data

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.

Issue #1147
Issue #1147

November 1, 2024

Issue #1146
Issue #1146

October 15, 2024

Issue #1145
Issue #1145

October 1, 2024

Sign Up For Our Free Newsletter

Join our free mailing list to receive our Newsletter- an elaboration on one topic from our most recent Twice-Monthly Report.

Expertise in Every Department

Manufacturing Controls

Observations including but not limited to process validation, equipment qualification and maintenance, deviations, customer complaints and training.

Sterile Manufacturing Controls

Observations including but not limited to environmental monitoring, sterilization validation, gowning procedures.

Active Pharma Ingredients

Observations including but not limited to quality, testing, manufacturing, packaging, document control.

Laboratory Controls

Observations including but not limited to method validation, calibration and preventative maintenance for instruments, sample preparation and reserve samples.

Packaging & Labeling

Observations including but not limited to label controls, label issuance, packaging verification.

Medical Device

Observations including but not limited to quality systems, performance qualification, purchasing, supplier verification and CAPA.

Sign Up For Our Free Newsletter

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.

Written complaints have historically been prioritized and more scrutinized by industry, viewing them as more […]

A recent inspection revealed a concerning discrepancy between retain samples and the actual marketed products, […]

In a recent 483, a relabeler was cited for failing to have lot numbers and […]

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