1. US Food and Drugs Administration (2004) Guidance for Industry PATA Framework for innovative pharmaceutical manufacturing and quality assurance. US Food and Drugs Administration, US Department of Health and Human Services, Rockville
2. ICH (2005) ICH harmonized tripartite guideline: pharmaceutical development. Q8
3. ICH (2005) ICH harmonized tripartite guideline: quality risk management. Q9
4. ICH (2007) Draft consensus guideline: pharmaceutical development. Annex to Q8
5. Chatterjee B, Green J (2007) Eight steps to PAT: using the design for Lean Six Sigma Toll-Gate Process as best practice. Pharm Eng 27:8–21