Updated Version Addresses Changing Regulatory Environment
(TAMPA, FLORIDA, USA, 03 November 2010 - ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, today announced that it will release GAMP® Good Practice Guide: Calibration Management, Second Edition on 7 November 2010, to coincide with the start of the 2010 ISPE Annual Meeting in Orlando, Florida. The Guide, which provides guidance in setting up a calibration management system, has been updated to reflect changing regulatory expectations from the USFDA.
"The FDA has been actively promoting a risk-based approach to GMP as part of the 21st Century Initiative," said 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 scope of the Guide 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 US$145/€105 for ISPE Members and US$380/€325 for non-members. More information can be found at www.ispe.org/cs/technical_documents_section/gamp_good_practice_guides_under_development.
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 22,000 technical professionals working in or serving the manufacturing sector or drug development in the pharmaceutical industry in 90 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop their 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 opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.