PDA TR28-2006 无菌原料药工艺模拟验证.pdfVIP

PDA Technical Report No. 28 Revised Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals Joint PDA/PhRMA Sterile Bulk Pharmaceutical Chemicals Task Force Co-Chairmen .James P. Agalloco, Agalloco Associates, Inc. (co-chair) Karl L. Hofmann, Bristol-Myers Squibb Co.-2nd Edition (co-chair) Max S. Lazar, Hoffmann-La Roche, Inc. (retired)-11 Edition (co-chair) .James E. Akers, Ph.D., Akers Kennedy Associates, Inc. Barbara .J, Bassler, Ph.D., Bridge Associates International, LLC Edgard Craenhals, Ph.D., Interchem Corp. (retired) Daniel H. Gold, Ph.D., D.H. Gold Associates, Inc. Samir Hanna, PhD., Bristol-Myers Squibb Co. (retired) T. David Hansen, Merck Co., Inc. Russell E. Madsen, The Williamsburg Group LLC Timothy R. Marten, Ph.D., AstraZeneca Pharmaceuticals David W. Maynard, Maynard Associates, LLC Leonard Mestrandrea, Ph.D., Pfizer, Inc. David A. Moyer, Fulcrum Pharma Development Gordon Munro, Ph.D., Medicines Control Agency Terry E. Munson, PAREXEL Consulting Barry A. Perlmutter, Process Efficiency Products .Jeffrey Probasco, GlaxoSmithKiine Robert S. Pullen, Pfizer, Inc . .Jean I. Olsen, GlaxoSmithKiine Max Sokol, Schering-Piough Research Institute (deceased) Gary E. Strayer, Merck Company, Inc. Constance C. Taylor, Merck Company, Inc . .John Teward, Ph.D., GlaxoSmithKiine Timothy L. Tuley, Eli Lilly Company Stelios C. Tsinontides, Ph.D., Merck Company, Inc. Colin Walters, Schering-Piough Research Institute Thomas X. White, PhRMA (retired) Alpaslan Yaman, Ph.D., Schering-Piough Note: Sidney Priesmeyer, FDA, St. Louis Branch, served as non-voting liaison for the first edition of this project; he was not a member of the commit