GAMP CoP UK Forum

Great to meet with other businesses at the forum on 11 Oct 2022, which focussed on the recent publication of ISPE GAMP 5 Second Edition. The presentations were very informative and prompted useful interactive discussions with the attendees. Many thanks to ITS for sponsoring the event at the Centre for Professional and Executive Development in Darlington.

GAMP 5 Second Edition

ISPE GAMP 5 Second Edition has been published! This document maintains the principles and framework of the First Edition, but has been revised to address the increased importance of service providers, evolving approaches to software development, use of software tools & automation, and the use of Critical Thinking by Subject Matter Experts.

Draft OECD Advisory Document on GLP and Cloud Computing

Draft OECD Advisory Document No.17 Supplement No.1: GLP and Cloud Computing, Version 5 is out for review. This document describes the expectations of Good Laboratory Practice (GLP) compliance authorities regarding cloud-based solutions implemented at GLP test facilities.