With the 3 guidelines Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10), the International Conference on Harmonisation (ICH) has established a new approach to ensuring pharmaceutical quality. Still, many questions remain unanswered, especially with regard to the implementation of these requirements.
Therefore, the ICH has decided to publish an official contact address to which everybody can submit questions on the implementation of the above-mentioned guidelines. These questions will then be forwarded to the members of the working groups and answered as soon as possible. This e-mail address, to which you can send your questions on the guidelines, is firstname.lastname@example.org.
Moreover, the ICH has published two interesting presentations on its website. On the implementation of Q8, Q9 and Q10, you can find the presentation by George France, Wyeth/EFPIA, and the Quality IWG. The new Annex to Q8 is explained in a presentation by Robert Baum, Pfizer/PhRMA, and the Q8 (R1) EWG.
On behalf of the European Compliance Academy (ECA)