ICH-Q10: A Recipe for the Product Life Cycle - Pharmaceutical Technology

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ICH-Q10: A Recipe for the Product Life Cycle
The draft guidance ICH Q10 for pharmaceutical quality systems is part of the ongoing move to a science- and risk-based approach in manufacturing.

Pharmaceutical Technology


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), http://www.fda.gov/cder/guidance/7260fnl.htm, accessed Aug. 1, 2007.


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