1. US Food and Drug Administration (FDA), Department of Health and Human Services, Pharmaceutical Quality for the 21st Century A Risk-Based Approach Progress Report, May 2007 (http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm128080.html).
2. US Food and Drug Administration (FDA), Guidance for industry PAT-A framework for innovative pharmaceutical manufacturing and quality assurance, FDA, Washington, DC, USA, 2004.
3. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q8 (R2): Pharmaceutical Development, ICH, Geneva, Switzerland, 2009.
4. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q9: Quality Risk Management, ICH, Geneva, Switzerland, 2005.
5. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q10: Pharmaceutical Quality System, ICH, Geneva, Switzerland, 2008.