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.

Issue #1100

November 15, 2022

QSR-22Q4

November 15, 2022

Issue #1099

November 1, 2022

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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.

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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.

Employee training is a vital part of any robust quality management plan.  GMP Trends Annual […]

According to 21 CFR 820.30(g), as part of the design validation process, risk analysis must […]

Buildings used in the manufacture, processing, packing, or holding of drug products must be maintained […]