References
1. ICH, ICH Q8 Pharmaceutical Development (ICH, Geneva, Nov. 10, 2005),
http://www.ich.org/LOB/media/MEDIA1707.pdf, accessed Aug. 15, 2007.
2. ICH, ICH Q9 Quality Risk Management (ICH, Geneva, Nov. 9, 2005),
http://www.ich.org/LOB/media/MEDIA1957.pdf, accessed Aug. 15, 2007.
3. ICH, ICH Q10 Draft Consensus Guideline Pharmaceutical Quality System (ICH, Geneva, May 9, 2007),
http://www.ich.org/LOB/media/MEDIA3917.pdf, accessed Aug. 15, 2007.
4. J.C. Famulare, "Pharmaceutical Quality Systems, PQS, Enhanced by QbD for the Product Life Cycle," presented at the ISPE
PQLI Workshop, Crystal City, VA, June 2007.
5. FDA, Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations (FDA, Rockville, MD, September 2006),
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