1. FDA. Pharmaceutical CGMPs for the 21st century: a risk-based approach. Rockville: US Food & Drug Administration; 2002.
2. ICH. ICH Q8: pharmaceutical development, step 4 (Geneva, 10 Nov 2005).
3. ICH. ICH Q8: (R1): pharmaceutical development revision 1, step 3 (draft, Geneva, 1 Nov 2007).
4. ICH. ICH Q9: quality risk management, step 4 (Geneva, 9 Nov 2005).
5. International Conference on Harmonization. Q10, Pharmaceutical quality system. Geneva, Switzerland. 2007.