Hundreds of millions of Americans rely on life-saving and sustaining medications and medical devices every day. Ensuring the drugs and devices that they depend on are not contaminated is critical for the health of the country, and the responsibility of the U.S. Food and Drug Administration (FDA).
To address safety concerns in the medical, pharmaceutical, and food industries, the FDA established and enforces GMP or Good Manufacturing Practice regulations. These necessary steps and precautions guarantee that everything produced and shipped is safe, and meets purity and quality standards. GMP guidelines should be clearly stated in each manufacturer’s quality control plan, as the regulations serve to limit instances of cross-contamination, mixed raw materials, or unqualified staff working on crucial production points.
Although highly regulated, GMP framework is very open-ended, allowing manufacturers to set their own quality control procedures that work best with their business model and goods being produced. This freedom grants businesses a way to make sure they are doing exactly what is right for themselves and their customers while following established guidelines that serve as a baseline for quality and safety.
There is an additional component to GMP, with the regulations often referred to as cGMP. The difference is the “c” which symbolizes “current” – meaning manufacturers must strive to keep their equipment and production floor as modern as possible to comply with current standards. Crucial equipment and systems that were once state-of-the-art pieces of machinery can age out and may not meet current standards.
MadgeTech data loggers are essential for complying with GMP regulations, especially those that must maintain specific environmental conditions. Failure to meet proper temperature and humidity levels can result in spoiled food or unsafe medicines. MadgeTech data loggers provide continuous monitoring and automatic reports to validate constant adherence to GMP regulations.
To learn more about how MadgeTech data loggers can simplify compliance requirements, call us at (603) 456-2011 or email [email protected].