Kaplan Eduneering: The Focus on Quality Risk Management

The Focus on Quality Risk Management

In August 2002, the Food and Drug Administration (FDA or the Agency) announced a significant new initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century, to enhance and modernize the regulation of pharmaceutical manufacturing and product quality — to bring a 21st century focus to this critical FDA responsibility.

The initiative was intended to modernize FDA’s regulation of pharmaceutical quality for veterinary and human drugs and select human biological products such as vaccines. As part of this initiative, both the pharmaceutical, as well as the chemistry, manufacturing, and controls (CMC) regulatory programs were evaluated with the following objectives in mind.

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The Focus on Quality Risk Management

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