1. ICH Harmonised Tripartite Guideline. International committee of harmonisation of technical requirements for registration of pharmaceuticals for human use.Q8: Pharmaceutical Development. 2003.
2. US Food and Drug Administration, Department of Health and Human Sciences. Pharmaceutical cGMPs for the 21st Century-A Risk-Based Approach. 2004.
3. J. Woodcock. Pharmaceutical quality in the 21st century—an integrated systems approach at AAPS workshop on pharmaceutical quality—a science and risk based approach in the 21st century. 2005.
4. Mock P2 for “Examplain” Hydrochloride. Available at: http://www.efpia.org/Content/Default.asp?PageID = 263&DocID = 2933. Accessed March 5, 2008.
5. Potter C, Beerbohm R, Coupe A, Erni F, Fischer G, Folestad S, et al. A guide to EFPIA’s Mock P.2 document. Pharmaceutical Technology Europe. Available at: http://www.ptemag.com/pharmtecheurope/PAT/A-guide-to-EFPIAS-Mock-P2-document/ArticleStandard/Article/detail/392205. Accessed March 5, 2008.