1. Anon (2004) PAT Guidance for Industry – A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance, US Department of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA)
2. ICH Harmonised Tripartite Guideline: Pharmaceutical Development Q8 (R2);Anon,2009
3. ICH Harmonised Tripartite Guideline: Q9 Quality Risk Management;Anon,2005
4. ICH Harmonised Tripartite Guideline: Q10 Pharmaceutical Quality System;Anon,2008
5. ICH Harmonised Tripartite Guideline: Q11 Development and Manufacture of Drug Substances;Anon,2012