1. ICH Q3D Step 4 16th December - Guideline For Elemental Impurities.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D_Step_4.pdf(accessed Oct 8, 2015).
2. Q7 Implementation Working Group - ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. Questions and Answers.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/ICH_Q7-IWG_QA_v5_0_14Apr2015_FINAL_for_publication_17June2015.pdf(accessed Oct 8, 2015).
3. ICH M7 Step 4 June 2014- Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M7/M7_Step_4.pdf(accessed Oct 8, 2015).
4. ICH Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities).Http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf(accessed Oct 8, 2015).
5. Regulatory Highlights