1. R. Giralt, "A New Definition for API Starting Materials," Pharmaceutical Technology Europe
16 (6), 2004.
2. ICH, Q11: Development and Manufacture of Drug Substances (ICH, May 2011).
3. ICH Q9, Quality Risk Management (ICH, June 2006). This is directly applicable to the drug product manufacture but also
applies the risk-based thinking with regard to the drug substance.
4. Muller et al., "A Rationale for Determining, Testing, and Controlling Specific Impurities in Pharmaceuticals that Possess
Potential for Genotoxicity," Regulatory Toxicology and Pharmacology
44, 198–211, (2006).
5. A. Thayer, "Genotoxic Impurities," C&E News Sept. 2010, 88 (39), pp. 16–26.
6. FDA, Draft Guidance for Industry: Fermentation Derived Intermediates, Drug Substances, and Related Drug Products (FDA, Dec. 2002)
7. S. Schaeffer, "Equivalence Test Case," Biocentury
18 (34), A1–A7 (2010).
8. ICH, Q8(R2) "Quality Target Product Profile" definition; see also Spring 2011 GPHA Meeting Slides by R. Lionberger; Yu,
25 781–791, 2008.
The views and opinions in this article are only those of the author and do not necessarily reflect the views or policies of
the US Food and Drug Administration.
The author thanks Naiqi Ya, Dave Skanchy, Bob Iser, and Aloka Srinivasan for their scientific input.
Barbara Scott is a chemistry and manufacturing reviewer (CMC) at the Office of Generic Drugs within the Office of Pharmaceutical Science,
under the US Food and Drug Administration's Center for Drug Evaluation and Research, Barbara.Scott@fda.hhs.gov