Because of the rapid growth of the global supply chain for the pharmaceutical industry, increased risk management is essential
to ensure regulatory compliance and consumer safety. By implementing the ideas and tools described in this article, the pharmaceutical
manufacturer will reduce risk, enhance patient safety, and ensure long-term success for its products.
Sarah Wood* is a quality-systems manager, Ronald Dunn is the director of quality systems, Marsha Nelson is a senior quality engineer, Taunya Alexander is a quality-program manager, and Larry Servi is the director of product and process development, all at Regulatory Compliance Associates, 7401 104th Ave., Suite 160,
Kenosha, WI 53142, tel. 262.842.1250, fax 262.842.1251, firstname.lastname@example.org
. Susan Schniepp is the president of Schniepp and Associates and a member of Pharmaceutical Technology's Editorial Advisory Board.
*To whom all correspondence should be addressed.
1. D.H. Stamatis, Failure Mode and Effect Analysis: FMEA from Theory to Execution, (American Society for Quality, Milwaukee, WI, 2nd ed., 2003).
2. Dyadem Press, Guidelines for Failure Modes and Effects Analysis (FMEA) for Medical Devices, (CRC Press, Boca Raton, FL, 2003).