(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.”

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