Changes Ahead for EU GMP Guide on APIs

Changes to Part 2 of the EU GMP guide will come into force by 31 July 2010 in order to bring it in line with the ICH Q9 guideline on Quality Risk Management. As a result, it will no longer be identical to the ICH Q7 guideline on APIs - a harmonised guideline for the US, Europe and Japan. In fact the new guide will include more requirements than the original ICH Q7 text.

The ICH Q7 Guideline was transferred to the EU regulation by amending the EU GMP Guide (Annex 18). Annex 18 is called Part 2 of the EU GMP Guide while Part 1 includes the GMP requirements for medicinal products. According to a press release issued by the European Compliance Academy, the revisions to Annex 2 were necessary to make clear that all annexes (1–20) are applicable to both medicinal product manufacturers and API manufacturers.

The following reason was provided with the publication of the revised text: "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."

Please click here to view the new Part 2 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Part II: Basic Requirements for Active Substances used as Starting Materials.