The topics described in this article have been developed and discussed by members of the ICH Quality Implementation Working
Group, namely: Jean-Louis Robert (rapporteur), Diana Amador-Toro, Robert G. Baum, Nicholas Cappuccino, David Cockburn, Georges
France, Richard L. Friedman, Nigel Hamilton, Sabine Kopp, Hirotada Nagai, Yukio Hiyama, Takao Kyohara, Fusashi Ishikawa, Sabine
Kopp, Urs Kopp, Akira Kusai, Yoshihiro Matsuda, Motoaki Mitsuki, Elaine Morefield, Jacques Morénas, Masatoshi Morisue, Markus-Peter
Müller, Tamiji Nakanishi, Moheb Nasr, Kazuhiro Okochi, Anthony Ridgway, Rachael Roehrig, Stephan Rönninger, Swroop Sahota,
Hideki Sasaki, Tetsuhito Takarada, Shigheki Tamura, Krishnan Tirunellai, Mats Welin, and Jean M. Wyvratt.
Stephan Rönninger is deputy topic leader for EFPIA in the ICH Q–IWG and head of External Collaboration Europe/Japan/CEMA at F. Hoffmann-La
Roche. Sabine Scheitlin is operational support manager at F. Hoffmann-La Roche, both based in Basel, Switzerland, tel. +41 61 688 69 74.
1. ICH Steering committee (Brussels, Belgium, 2003).
2. ICH, Q8, Q9, Q10 Implementation, Question and Answers (Q&A), November 2010 (
3. ICH, Q8, Q9, Q10 Implementation, Training material, November 2010 (
4. ICH, Q8, Q9, Q10 Implementation, Points to Consider, December 2011 (
5. FDA, Guidance for Industry: Process Validation: General Principles and Practices (Rockville, MD, 2011).