6Fredenck J Carleton and James P Agalloco编 上海医药行业协会译.无菌制药工艺的验证[M].上海科技普及出版社,1998.12.
7Keith Bader, John Hyde, Peter Watler, and Amber Lane. Online Total Organic Carbon (TOC) as a Process Analytical Technology for Cleaning Validation Risk Management. Pharmaceutical Engineering, January/February 2009:8419.
8Herbert J. Kaiser,Ph. D. & Bruce Ritts,M. S. Validation of Analytical Methods Used in Cleaning Validation [J]. Journal of Validation Technology, 2004,10 ( 3 ): 219.
9Food and Drug Administration "Guide to Inspections,Validation of Cleaning Processes" Office of Regulatory Affairs,FDA,Rockville,MD,1993.
10ICH "Guidance for Industry Q2B Validation of Analytical Procedures:Methodology"FDA, Rockville, MD 1996.