1Herbert 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.
2Food and Drug Administration "Guide to Inspections,Validation of Cleaning Processes" Office of Regulatory Affairs,FDA,Rockville,MD,1993.
3ICH "Guidance for Industry Q2B Validation of Analytical Procedures:Methodology"FDA, Rockville, MD 1996.
4William E, Hall M. Determining appropriate acceptance criteria for cleaning programs [J]. J Valid Technol, 2004, 10(2): 120.
5Layton D W, Mallon B J, Rosenblatt D H, et al. Deriving allowable daily intakes for systemic toxicants lacking chronic toxicity data [J]. J Regul Toxicol Pharm, 1983, 3(1) :224.