The International Society for Pharmaceutical Engineering (ISPE) will release its GAMP® Good Practice Guide: Calibration Management, Second Edition on Nov. 7, coinciding with the start of its Nov. 7-10 annual meeting in Orlando, FL. The Guide, which provides guidance in setting up a calibration management system, has been updated to reflect changing regulatory expectations from the U.S. Food and Drug Administration.
“The FDA has been actively promoting a risk-based approach to GMP 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 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 is a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals. The organization has a Packaging Community of Practice that now has more than 1,700 members. Read here for a report on last year's ISPE COP event.
“The FDA has been actively promoting a risk-based approach to GMP 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 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 is a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals. The organization has a Packaging Community of Practice that now has more than 1,700 members. Read here for a report on last year's ISPE COP event.
