FDA to revamp cGMP guidelines to adopt risk-based approach. (Pharmaceuticals & Fine Chemicals).(US Food and Drug Administration current good manufacturing practices)(Brief Article)

Chemical Market Reporter, September, 2002 by Jarvis, Lisa

THE FOOD and Drug Administration (FDA) plans to introduce sweeping reforms over the next several years to the way pharmaceutical quality systems and current good manufacturing practices (cGMP) are regulated. The move comes as the agency finds its resources stretched to the limit, coinciding with a number of high-profile manufacturing-related drug recalls.

The pharmaceutical industry has embraced the measure, which it hopes will inject more consistency and predictability into the regulatory process. The FDA says it is looking to "make a very good system better" by reassessing the manufacturing guidelines, which cover both animal and human health products, including biologics, for the first time in 25 years. "FDA'S regulatory and quality control systems for...

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