FDA

FDA

FDA

Implementation of a Modern Risk-Based Approach

On February 20, 2003, the Food and Drug Administration (FDA) released its first progress report on a major initiative concerning the regulation of drug product quality. The 2-year initiative, Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach (the Pharmaceutical cGMP initiative), which was launched on August 21, 2002, applies to human drug and biological drug products and veterinary drugs and has several objectives.

Appropriate Steps

To encourage the early adoption of new technological advances by the pharmaceutical industry

To facilitate industry application of modern quality management techniques, including implementation of quality systems approaches, to all aspects of pharmaceutical ...