REFERENCES
1. US Food and Drug Administration, Center for Drug Evaluation and Research, http://fda.gov/CDER/.
2. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use,
ICH Harmonized Tripartite Guideline, Pharmaceutical Development Q8, November 2005.
3. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use,
ICH Harmonized Tripartite Guideline, Quality Risk Management Q9, November 2005.
4. Gibson M. Technology Transfer: An International Good Practice Guide for Pharmaceutical and Allied Industries. Illinois:
DHI Publishing, 2005.
5. Schmidt SR, Launsby RG. Understanding Industrial Designed Experiments, 4th Ed. Colorado: Air Academy Press, 2000.
6. Brefogle FW. III. Implementing Six Sigma. New Jersey: Wiley and Sons, 1999.
7. Womack JP, Jones DT. Lean Thinking. New York: Simon & Schuster, 1996.
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