PDA TR13-2001 Fundamentals of an EM program英文原版资料.pdfVIP

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PDA TR13-2001 Fundamentals of an EM program英文原版资料.pdf

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PDA E nvir onmental Monitoring Task For ce Jeanne E . Moldenhauer, Chairperson, Vectech Pharmaceutical Consultants, Inc. Aijaz Ahmad, Genentech, Inc . Susan E . Arrigoni, Ortho-Clinical Diagnostics Anthony M . Cundell, Ph .D., Wyeth-Ayerst Pharmaceuticals Gary E . Strayer, Merck Company, Inc. John H. Ducote, Chiron Corporation Susan F. Elder, Glaxo Wellcome, Inc . Mary B eth Grace, Genentech, Inc . David A . Ness, Abbott Laboratories, Inc . Thaddeus G . Pullano, Ph.D ., Wyeth-Lederle Vaccines and Pediatrics J ames F. Quebbeman, Parke-Davis Company Berit Reinmtiller, Royal Institute of Technology Miriam Rozo, Ortho-Clinical Diagnostics Lydia Troutman, Schering-Plough Corporation Technical Reviewer s Russell E. Madsen, PDA Robert Mello, RJM Pharmaceutical Consultants Kenneth H. Muhvich, Ph.D., The Validation Group Glenn Wright, Eli Lilly Company Acknowledgements Franco De Vecchi, VPCI, for providing information relating to HVAC systems and environmental monitoring. Anne Marie Dixon, Clean Room Management Associates, Inc ., for providing the ISO information required for this document. Phyllis Karpiel, Fujisawa Healthcare, Inc., for providing the majority of the typ- ing support. Steve Yentes, Pfizer, Inc ., for providing technical review of the document. Elizabeth Joyce, Jordan Pharmaceuticals, Inc ., for providing technical writing review of the document. Fundamentals of an Environmental Monitoring Program Technical Report No. 13 Revised PDA September/October 2001 Vol. 55, No.5, September/October 2001, Supplement TR13, Revised PDA TECHNICAL REPORT NO. 13 REVISED FUNDAMENTALS OF AN ENVIRONMENTAL MONITORING PROGRAM Table of Contents 1.0 INTRODUCTION . .. . . 1 2.0 ENVIRONMENTAL CLASSIFICATIONS . 1 3.0 SURVEILLANCE SUPPORT . 6 3.1 Cleaning and Sanitization/Disinfection .. . .. ... ... ... ... .. .. ... 6 3.2 Sample Site Selection . . .. ... 6