Introduction on GAMP5
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Good Automated Manufacturing Practice (GAMP) has always been at the forefront of Delivering Today, Transforming Tomorrow. The next version of the GAMP Guide for Validation of Automated Systems (GAMP5) introduces important tools to ensure that ISPE’s computer validation guidance reflects current industry and regulatory thinking regarding the incorporation of science-based risk management principles into the efforts of validating computer applications and qualifying regulated equipment.
This emphasis on well-understood processes and potential risk to patient safety aligns with initiatives such as FDA’s cGMPs for the 21st Century and ICH Q8, Q9, and Q10. Within this scope, leveraging the work of suppliers is also a key factor.
Posted by ISPE - ENGINEERING PHARMACEUTICAL INNOVATION at 8:52 AM | MAKE A COMMENT
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