Post a comment

Introduction on GAMP5

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.

Leave your comment Choose an identity MyPodcast user Other Anonymous Username Password Name Web page All of these fields are optional. Type code: Typing characters from the picture helps to ensure that this comment is being created by a real person and not by an automated program