1. Final Report on Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach;U.S. Food and Drug Administration,2004
2. Anon., 2012. See, for example: Guidance for Industry: PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (Sep 2004); Guidance for Industry: Q8(2) Pharmaceutical Development (Nov 2009); Guidance for Industry: Q9 Quality Risk Management (Jun 2006); Guidance for Industry: Q10 Pharmaceutical Quality System (Apr 2009); and Guidance for Industry: Q11 Development and Manufacture of Drug Substances (Nov 2012).