1. 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). September, 2004.
2. Guidance for Industry: Q8(R2) Pharmaceutical Development, ICH Harmonised Tripartite Guideline, Step 4, August 2009.
3. Guidance for Industry: Q9 Quality Risk Management, ICH Harmonised Tripartite Guideline, Step 4, November 2005.
4. Guidance for Industry: Q10 Quality Systems Approach to Pharmaceutical CGMP Regulations, ICH Harmonised Tripartite Guideline, Step 4, June 2008.
5. Guidance for Industry: Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), ICH Harmonised Tripartite Guideline, Step 4, May 2012.