As Benjamin Franklin noted, and as countless authors have affirmed since then, an ounce of prevention is worth a pound of cure. That is the animating principle of the U.S. Food and Drug Administration’s Current Good Manufacturing Practices (cGMP) regime. Proactive compliance with these standards may minimize companies’ exposure to severe recalls, government investigations and lawsuits. It is probably also good business in its own right.
Overview of FDA’s cGMP Regulations and Related Programs
Like many acronyms that emanate from Washington, D.C., the cGMP program imposes a variety of complex obligations and “suggestions” on FDA-regulated industries. Much of the food industry is also subject to an additional layer of regulation called Hazard Analysis Critical Control Points (HACCP), and the cGMP program for medical device makers is wrapped into a broader framework of Quality System (QS) regulations.
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