'Risk Management for the Pharmaceutical Industry'
Fujitsu principal consultant pens Pharmaceutical Processing magazine article
by Edward Griffith
Reproduced with permission from Pharmaceutical Processing magazine – March 1, 2004
Every product and every process has an associated risk. Every enterprise should have a methodology for identifying and evaluating the risks it faces and it should have a process for generating intervention plans to reduce the risks to an acceptable level. This process is generally referred to as a Risk Management Plan (RMP).
The FDA's Risk-Based Approach Initiative
In early 2002, the FDA announced its "Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century: A Risk-Based Approach." According to the FDA position paper, "... it is time to step back and evaluate the currency of these [drug cGMP] programs so that:
- The most up-to-date concepts of risk management and quality systems approaches are incorporated while continuing to ensure product quality;
- The latest scientific advances in pharmaceutical manufacturing and technology are encouraged;
- The submission review program and the inspection program operate in a coordinated and synergistic manner;
- Regulation and manufacturing standards are applied consistently;
- Management of the program encourages innovation in the pharmaceutical manufacturing sector; and FDA resources are used most effectively and efficiently to address the most significant health risks."
