1. ICH Q8(R2) Pharmaceutical Development 2009 International Conference of Harmonization
2. ICH Q9 Quality Risk Management 2005 International Conference of Harmonization
3. ICH Q10 Pharmaceutical Quality System 2008 International Conference of Harmonization
4. ICH Q11 Development and Manufacturing of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) 2012 International Conference of Harmonization
5. M. Degerman E. Hansen L. Sejergaard T.B. Hansen J. Krarup S. Frederiksen S. Kidal A. Staby Model based process development in biopharmaceutical industry-case studies Puerto Vallarta, Mexico 2011