GAMP 5 is an updated and expanded version of the previous version with updated appendices and a more technical-based approach to offering information, as mentioned in the video. So, what can readers expect to find in GAMP 5, and what can they expect from that information?
This eviction covers GPGs and what to expect and if they are still current and up to date. The creators also considered if any details need to be changed or retired.
The result was the creation of the Enabling Innovation Guide or the ISPE GAMP Good Practice Guide.
Upon analysis, all components were correct, except for technological advances, which weren’t covered. Updates were added to encompass new technology and the operational areas aspects. The beginning of the manual is updated in terms of the key concepts.
The appendices were also updated to reflect new topics that needed to be addressed. That equated to most of the rework on the manual. The goal was to add clarity and add some emphasis on some portions. The lifecycle approach was made clearer and intended to reflect that it’s not linear.
GAMP 5 is a revised and reworked approach to the previous version. Readers can expect to see updated information and concepts redesigned to reflect technological advances and clarify processes.