Preparing for changes in FDA guidelines

This white paper by Clarkston Consulting describes an innovative approach to inspections and quality awareness for the pharmaceutical industry based on the US Food and Drug Administration (FDA) report, "Pharmaceutical cGMPs for the 21st century—a risk-based approach." The report addresses issues including the effects of changing current Good Manufacturing Practices (cGMPs) on FDA inspections, the need for pharmaceutical companies to implement new technologies and manufacturing quality goals and cooperation with international regulatory partners. The FDA's own internal approach to risk management and quality systems are being applied to the manufacturer's  internal processes as well.

Clarkston Consulting recommends that companies continuously evaluate their processes to reduce variability, using data as a basis. A thorough evaluation of the processes in the product lifecycle should be reviewed with appropriate documentation.

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