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About GMP Trends®
GMP Trends® provides relevant, real-time, unbiased information from actual U.S. FDA inspections. We obtain immediate access to all FDA inspection information on a real-time basis.
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.
Stay Ahead of the FDA
Give us 15 minutes and we'll show you how our exclusive GMP Trends content can help thousands of regulatory affairs professionals stay in compliance.
Expertise in Every Department
GMP Trends® provides 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.
Manufacturing Controls
Observations concerning process validation, equipment qualification and maintenance, deviations, customer complaints and training.
Sterile Manufacturing Controls
Observations concerning environmental monitoring, sterilization validation, gowning procedures.
Active Pharma Ingredients
Observations concerning quality, testing, manufacturing, packaging, document control.
Laboratory Controls
Observations concerning method validation, calibration and preventative maintenance for instruments, sample preparation and reserve samples.
Packaging & Labeling
Observations concerning label controls, label issuance, packaging verification.
Medical Device
Observations concerning quality systems, performance qualification, purchasing, supplier verification and CAPA.
GMP Trends® Subscription Packages
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- Annually
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- 5 USERS
- 24 Issues, Print & Mail
- Trend Archives
- Annual Trend Report
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- FDA-483 Observation Reports
GMP Trends® has been an extremely valuable tool for our company. It is widely read by most of our operational groups from Quality to Research and Development to Pharmacovigillance. Everyone eagerly awaits the latest issue! Thank you for producing such a useful, quality publication, and after almost 20 years, we look forward to another 20 years and more!
David Midyette, MA, MLIS - Watson Laboratories, Inc.
GMP Trends® has been of special value as used in seminars on Law and Regulations. Not only do they help to verify current GMP discrepancies that continue to be encountered in the relevant industries, but they do so with excerpts in the FDA-483 format. These help to provide a 'real life' aspect to the classroom scenarios.
Wayne A. Mazanec - Seminars
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