An amendment is made to Part II of the GMP Guide to incorporate principles of Quality Risk Management in line with the ICH Q9 guideline on Quality Risk Management. Amendments correspond to similar changes made to Part I Chapter 1 of the Guide and published in February 2008. A new section on Quality Risk Management is
introduced as section 2.19. The remaining sections of chapter 2 are renumbered. A minor change is made to section 2.21. No other changes have been made.
Deadline for coming into operation 31 July 2010
Authors Note:- Eudralex Part II to GMP guide is an adoption of ICH Q7 and gives comprehansive view of GMPs for APIs. To download, click the title of the post !