1. Guidance for Industry, PAT: A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Re16 Johansson et al. search (CDER), Center for Veterinary, Medicine (CVM), Office of Regulatory Affairs (ORA), Pharmaceutical CGMPs, September 2004. URL:
http://www.fda.gov/cder/guidance/6419fnl.htm
. and U.S. Food and Drug Administration (FDA) PAT web site:
http://www.fda.gov/cder/OPS/PAT.htm
2. European Medicines Agency (EMEA) PAT web site:
http://www.emea.eu.int/Inspections/PAThome.html
3. ICH Q8A Pharmaceutical Development, ICH guidance for industry, May 2006, and ICH Q9A Quality Risk Management, ICH guidance for industry, June 2006, and, ICH Q10 Quality Systems, ICH draft guidance for industry, May 2007, and FDA Guidance for Industry, Process Validation: General Principles and Practices, Nov 2008. All are accessible at FDA web site:
http://www.fda.gov/cder/guidance/
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