1. Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century - A Risk-Based Approach;FDA,2002
2. Concept Paper on the Development of Toxicological Guidance for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities;EMA,2011
3. Quality Risk Management Q9;ICH,2005
4. Pharmaceutical Quality System Q10;ICH,2008
5. Pharmaceutical Development Q8 (R2);ICH,2009