1. Yu LX. From our perspective: patients deserve quality medications; 2015. http://www.fda.gov/Drugs/NewsEvents/ucm428298.htm (accessed June 25, 2015).
2. FDA pharmaceutical quality oversight;Yu;Int Journal of Pharm,2015
3. U.S. FDA Guidance for Industry on Process Validation: General Principles and Practices, 2011.
4. European Medicines Agency. Guideline on process validation for finished products—information and data to be provided in regulatory submissions; 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/02/WC500162136.pdf (accessed June 25, 2015).
5. .