Cleaning Acceptance Limits for APIs-摘要.docxVIP

Table A. 1992 Pharmaceutical Manufacturers Association surveyon acceptance limits.Table B. 2006 Parenteral Drug Association survey on acceptance limits.TableC. Calculationforaswabsamplelimitandsimulatedresults.Table D.PDA’s Technical Report No.29inSection 8.5 “The Basisfor Quantitative Limits.”Table E. Comparison of 1/1,000th limits to ADE limits for teratogens.Table F. Comparison of 1/1,000th limits for low and high riskcompounds.