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ISPE

FDA Compliance

New Edition of GAMP Good Practice Guide Released

ISPE’s updated version addresses changing regulatory environment

Published: Monday, November 8, 2010 - 16:04

(ISPE: Tampla, FL) --  ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, has announced the release of GAMP Good Practice Guide: Calibration Management, Second Edition, which coincided with the start of the 2010 ISPE Annual Meeting in Orlando, Florida, on Nov. 7. The guide, which helps users set up a calibration management system, has been updated to reflect changing regulatory expectations from the U.S. Food and Drug Administration (FDA).

“The FDA has been actively promoting a risk-based approach to GMP [good manufacturing practices] as part of the 21st Century Initiative,” says Bob Best, ISPE president and CEO. “The change in approach to validation and compliance now puts more focus on the integrity, security, and reliability of process control systems and the instrumentation supporting them. The second edition of the GAMP Good Practice Guide: Calibration Management gives the insight needed to address the subject from these new areas of focus while still satisfying international GxP regulatory expectations.”

Developed by the Calibration Management Special Interest Group of ISPE’s GAMP Community of Practice (COP) in conjunction with pharmaceutical industry representatives and regulators, the guide describes the principles of calibration and presents guidance in setting up a calibration management system, providing the structured approach required to establish formal criticality assessment, management, documentation, and corrective actions vital to regulatory compliance. In the second edition, the guide’s scope has been widened to include related industries, laboratory, and analytical instrumentation.

The GAMP Good Practice Guide: Calibration Management, Second Edition will be available for purchase in book form or as a downloadable PDF at a cost of $145 for ISPE members and $380 for nonmembers. More information about the guide can be found here.

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ISPE

The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.