Part 2 EU GMP Guide on APIs Will No Longer Be Identical to ICH Q7

The ICH Q7 Guideline on GMP for Active Pharmaceutical Ingredients (APIs) is a harmonised guideline. The requirements are identical in the US FDA regulated environment as well as in Europe and Japan.

In Europe the ICH Q7 Guideline was transferred to the EU regulation by amending the EU GMP Guide (Annex 18). The content of Annex 18 is today called Part 2 of the EU GMP Guide. Part 1 includes the GMP requirements for medicinal products. The change was necessary in order to make clear that all annexes (1 - 20) are applicable to both medicinal product manufacturers and API manufacturers. For that reason a number of EU GMP annexes are currently under revision (e.g. Annex 2).

The European Commission published a revised Part 2 text which will enter into force by 31 July 2010. Very few people are aware of this new version because the European Commission was redesigned at the time of publication.

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."

Although these changes will incorporate further ICH guidelines into the EU GMP regulation, the consequence might cause some problems. From July 31 on, Part 2 of the EU GMP Guide includes more requirements than the original ICH Q7 text, which has been published in the US and Japan.

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 can be found here .

In the ECA Members Area you will find a comparison between the old and the new version. Click here to access the ECA Members Area.

The ECA and the European QP Association are currently developing a meeting in the US focussing on the EU GMP regulation and the differences compared to US FDA requirements. If you are interested in the event, please click here.

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