^*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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