1. Guidance for Industry Q8 (R2) Pharmaceutical development, November 2009(ICH Q8 (R2)) Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf Accessed June 6, 2013
2. Guidance for Industry Q9 Quality Risk Management, June 2006 (ICH Q9) Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073511.pdf Accessed September 23, 2013
3. Guidance for Industry Q10 Pharmaceutical Quality Systems, April 2009 (ICH Q10) Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073517.pdf Accessed September 23, 2013
4. Guidance for Industry Q11 Development and Manufacture of Drug Substances (ICH Q11) November 2012 (ICH Q11) Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm261078.pdf Accessed September 23, 2013
5. Quality Implementation Working Group on Q8, Q9 and Q10 Questions & Answers (R4), November 11, 2010 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_9_10_QAs/Q-IWG_QAs_Step4/Q8_Q9_Q10_Question_and_Answer_R4_step_4_November_2010.pdf Accessed September 9, 2013