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New edition of the GAMP 5 guide ‘A Risk-Based Approach to compliant GxP Computerized Systems’ expected in 2022

The ISPE announced in February that a new, second edition of the GAMP 5 guide will be released in July 2022. Read more about this new edition here and join our upcoming webinar!
New edition of the GAMP 5 guide ‘A Risk-Based Approach to compliant GxP Computerized Systems’ expected in 2022

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It has been 14 years since the ISPE published the first edition of the GAMP 5 guide “A Risk-Based Approach to compliant GxP Computerized Systems.” It is worth noting that despite the time in which this guide was published, it has been the basis for the validation of many systems around the world.

What’s new?

In February, the ISPE announced that a new edition – the second edition of this guide – will be published in July 2022.

How’s the second edition coming along?

ISPE President Jörg Zimmermann stated the following earlier this year:

The primary purpose and goal of this revision is to publish a second edition of GAMP 5, which will provide updates, clarify the relationship between GAMP 5 and the GAMP® 5: Records and Data Integrity Guide, provide recognition of the FDA’s current work on computer software assurance (CSA), and an updated, dynamic, and evolving set of Appendices. The second edition of GAMP® 5 is scheduled for release this year, so stay tuned!

What else is coming soon?

A conference is planned during the ‘2022 ISPE Annual Meeting & Expo‘ which will take place from October 30 to November 2, 2022, in Orlando, FL USA, which can also be attended virtually. The scope of the conference will be as follows (Source: ISPE):

The “GAMP 5 Guidance – A risk-based approach to compliance for GxP computerized systems” was published in 2008 and is widely recognized as the leading practical guide for the implementation, management and operation of GxP computerized systems.  Since the original publication date, technology has moved on and, while the principles and framework are as applicable today as ever, the time since publication may give the impression that the content may not be up to date. This session will describe how, while retaining the principles and framework of the first edition, the publication of the second edition of GAMP 5 brings their application in the modern world up to date. It highlights the use of Critical Thinking by knowledgeable and experienced SMEs to define appropriate approaches. The presentations made in this session will serve as a basis for the “New GAMP 5 2nd Edition Roundtable” session to follow, which will provide an opportunity to deepen the revisions applied to the Second Edition. 

What’s important? 

At QbD Group, we are closely following the new release of the second edition of the GAMP 5 guide “A Risk-Based Approach to compliant GxP Computerized Systems”, in order to be ahead of the curve and provide our clients with the best service, as well as to support them in adapting their processes to this new version.

Register now for our upcoming CSV webinar

Make sure to not miss these important updates! 

FREE WEBINAR: GAMP 5 updates

On September 28, we are hosting a webinar where we will tell you all about the new, second edition of GAMP 5. Make sure to register below!

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