*Bold text in this chapter is by the author for clarity only.
1Medicinal chemistry is that group that selects or synthesizes the chemical to be screened by the research group. The research department itself often performs this task.
2Guidance for Industry Process Validation: General Principles and Practices, FDA January 2011.
3Albers-Schönberg, G., Joshua, H., Lopez, M.B., Hensens, O.D., Springer, J.P., Chen, J., Ostrove, S., Hoffman, C.H., Alberts, A.W., Patchett, A.A., Dihydromevinolin, a potent hypocholesterolemic metabolite produced by Aspergillus terreus. J Antibiot (Tokyo). 1981 May 34(5):507–12.
4ICH Guidance for Industry: Q9 Quality Risk Management, FDA, Jun. 2006 ICH.
5Guidance for Industry: PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance, FDA, Sep. 2004.
6Guidance for Industry; Q10 Pharmaceutical Quality Systems Q10, FDA, Apr. 2009 ICH; Guidance for Industry: Q9 Quality Risk Management, FDA, Jun. 2006 ICH.
7Guide to the Inspection of Quality Systems, FDA, Aug. 1999.
8Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach Final Report; FDA, Sept. 2004.
9ASQ web site.
10Technical Report No. 60, PDA, Process Validation: A Life Cycle Approach, 2013, p. 22—with permission.
11Merriam–Webster on line dictionary—http://www.merriam-webster.com/dictionary/critical.
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