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RSSISPE Publishes White Paper On Risk-based Qualification
August 22, 2005
Tampa, FL - ISPE, a global not-for-profit Society of pharmaceutical manufacturing professionals, has published a white paper, Risk-Based Qualification for the 21st Century. The paper addresses the challenges of improving and streamlining qualification for cost and time savings, while meeting the new regulatory focus on process understanding and risk mitigation. ISPE is seeking industry comment and feedback on the paper by 16 September 2005. To submit a comment, visit www.ispe.org/Risk_Based_Qualification.
Authored by a task team appointed by ISPE's International Leadership Forum, the white paper is a direct response to a request from the US Food and Drug Administration (FDA) for the Society to be a "catalyst for change" in the pharmaceutical industry. The FDA has recognized that qualification is an area whose main purpose is often lost: to ensure that equipment is fit for purpose. The FDA is emphasizing quality through systems of quality management, scientific application of process understanding, and controlling risks to the manufacturing process that could impact product quality.
About ISPE
ISPE is the Society of choice for more than 23,000 pharmaceutical manufacturing professionals in 80 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida; an Asia Pacific office in Singapore; a European office in Brussels, Belgium; and Affiliates and Chapters in 19 countries around the world. Visit www.ispe.org for additional Society news and information.
SOURCE: ISPE
