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Connecting Pharmaceutical Knowledge Join/Renew Create Account Login Store Skip to content Home Menu Browse Titles Browse Authors My Account -- -- -- Guidance Document Portal Untitled Document Welcome to the ISPE Guidance Document Portal Produced by pharmaceutical manufacturing industry professionals, ISPE Guidance Documents provide the practical, “real-world” information you need to help your company build on current best practices to meet and exceed regulatory standards. The rigorous process that goes into creating these Guides contributes to their standing as the industry standard for technical documents in pharmaceutical manufacturing. ISPE Members Gain instant online access to select ISPE Good Practice Guides with your ISPE membership (not including GAMP and Baseline Guides). Get started in just a few short clicks: Click on Login in the upper right-hand corner using your ISPE account information Once logged in, click on My Bookshelf in the upper right-hand corner In your Bookshelf, you will have access to select ISPE Good Practice Guides, in addition to any guides you've previously purchased. Members receive discounts on ISPE Baseline and GAMP Guidance Documents. Not a Member? Gain instant online access to select ISPE Good Practice Guides by joining ISPE. Membership benefits include: Instant access to select ISPE Good Practice Guides* Pharmaceutical Engineering® magazine Networking opportunities with more than 18,000 pharmaceutical professional peers worldwide Discounts on events, training, online learning, etc. And so much more! *Effective January 1, 2021, Good Practice Guides published after 1 January 2020 will be available for free on the ISPE Guidance Document Portal three years from the publish date. GAMP® Good Practice Guides are excluded from this member benefit. Join Today Subject Collections Campaign - 30 Day Access -- Good Practice Guides -- Publications by Some Author -- Publications by Fluharty, Jeffrey S. (Co-Lead) -- Publications by Johnson, Diana K. -- Publications by Auyeung, Benny -- Publications by Thempadiyil, Rajesh -- Publications by Smillie, Catherine -- Publications by Wölbeling, Christian -- Publications by Gross, Dennis M., MS, PhD -- Publications by Wood, Christopher, (Co-Lead) -- Publications by Wingate, Guy (Lead) -- Publications by Grevatt, Doug -- Publications by Ward, Anthony -- Publications by Whitehead, Paul -- Publications by Whalley, Edmund -- Publications by Heisterkamp, Alex -- Publications by Gore, Joan -- Publications by Haycocks, Nicholas -- Publications by Milligan, Christine -- Publications by Harrison, Elizabeth -- Publications by Nydell, Jennifer -- Publications by Edmond, Jean-Pierre -- Publications by Hura, Leo -- Publications by Adamson, Bob, (Co-Lead) -- Publications by Kanczewski, Ed -- Publications by Hughes, Rob, (Lead) -- Publications by Ruklic, Gregory, (Lead) -- Publications by Herrmann, Oliver, (Co-Lead) -- Publications by Rückert, Markus -- Publications by Hahmann, Uwe -- Publications by Robinson, Alan -- Publications by Haycocks, Nicholas, (Lead) -- Publications by Herberger, John, (Co-Lead) -- Publications by Ravizzini, Giuseppe (Co-Lead) -- Publications by Riege, David, (Lead) -- Publications by Koch, Karl -- Publications by Kuzian, Carole -- Publications by Kutza, Joseph, PhD -- Publications by Parline, Maurice -- Publications by Anderson, Erik -- Publications by Denk, Richard -- Publications by Otake, Hiroyuki -- Publications by Osburn, Michael F. -- Publications by Gierer, Daniel -- Publications by Ward, Peter -- Publications by Werling, Gerhard -- Publications by Gautam, Anurag -- Publications by Groskoph, John -- Publications by Wakeham, Charlie -- Publications by Gallon, Petter -- Publications by Glynn, David -- Publications by Wallin, Brian -- Publications by Gasman, Charles -- Publications by Gries, Stefan -- Publications by Oliver, Karen -- Publications by Gehle-Novak, Jennifer -- Publications by Smith, Frank J. -- Publications by Gunderlock, Rich -- Publications by Waddick, Linda -- Publications by Weisemann, Claus -- Publications by Wingate, Guy -- Publications by Gobulukoglu, Ismail, PhD -- Publications by O'Brien, James M. -- Publications by White, Christopher -- Publications by Orosz, Peter -- Publications by Iles-Smith, Peter -- Publications by Foss, Mark -- Publications by Hagopian, Brian, CPIP -- Publications by Miller, Lee -- Publications by Ravizzini, Giuseppe -- Publications by Potter, Christopher, PhD -- Publications by Price, Nigel -- Publications by Fluharty, Jeffrey S. -- Publications by Yoder, Steve -- Publications by Miller, Steven, R. -- Publications by Herberger, John -- Publications by Mercuri, Marzio -- Publications by Davis, Bruce -- Publications by Iliopoulos, Theodore -- Publications by Herrmann, Oliver -- Publications by Fischer, Diana -- Publications by Larrabee, Chad -- Publications by Irving, Paul -- Publications by Rauschnabel, Johannes -- Publications by St. Laurent, Nancy -- Publications by Famulare, Joseph -- Publications by Sadler-Williams, Esther -- Publications by Dupont, Christophe -- Publications by Biskup, Jeff -- Publications by Nethercote, Phil -- Publications by Martin, Jerold -- Publications by Farquharson, Gordon -- Publications by Litzinger, Lauren -- Publications by Cruset, Alain -- Publications by DeVito, Kristen -- Publications by Luna, Cecelia -- Publications by Charlesworth, Arthur -- Publications by Pelletier, Marc P., PhD -- Publications by Zoccolante, Gary -- Publications by Crichton, Mel -- Publications by Flueckiger, Andreas -- Publications by McClellan, Brian -- Publications by Cerezo, Miguel -- Publications by Aebi, Stefan -- Publications by Mangold, Marina -- Publications by Laibacher, Walfraid -- Publications by Petrillo, Peter -- Publications by Barlow, David -- Publications by Tollefsen, Robert -- Publications by Brownell, Elise -- Publications by Spataro, Maureen E. -- Publications by Abell, Chris -- Publications by Egee, Paul S. -- Publications by Thorne, Ian -- Publications by Cruz, Miriam -- Publications by Dahmen, Kimberly A. -- Publications by Micklewright, Althea -- Publications by Andrews, John -- Publications by Davis, Ethan, PMP -- Publications by Jordan, Mark -- Publications by Clark, Chris -- Publications by Myers, Robert -- Publications by Akerlindh, Katrin -- Publications by Linder, John -- Publications by Spanel, Greg -- Publications by Cox, James -- Publications by Freeman, W. Roderick -- Publications by Jensen, Flemming Steen -- Publications by Middelber, Catherine E. -- Publications by Dugdale, Gary, BEng (Hons) CEng MIET -- Publications by Flynn, Gayle -- Publications by Le Meur, Pierre -- Publications by Lepore, John -- Publications by Sipe, Cameron -- Publications by Seesing, Marloes -- Publications by Swarts, Julie -- Publications by Naumann, Bruce D., PhD, DABT -- Publications by Schroeder, Sandee -- Publications by Sanders, Genni -- Publications by Schmitt, Siegfried -- Publications by Nahabedian, Armen J. -- Publications by Silva, Jason -- Publications by Butler, Mark A. -- Publications by Takao, Makoto -- Publications by Venkateshwaran, Thirunellai G., PhD -- Publications by Perez, Arthur "Randy" -- Publications by Mooney, Craig -- Publications by Block, Joerg -- Publications by Samways, Kate -- Publications by Abdelkafi, Chedia -- Publications by Baker, Kate -- Publications by Gardner, Beth -- Publications by Wrightson, Ann -- Publications by Watson, Timothy -- Publications by Cheesman, David -- Publications by Young, Jeff -- Publications by Ruklic, Gregory -- Publications by Henrichmann, Frank -- Publications by Meyer, Julia -- Publications by Santiago, Evelyn -- Publications by Gonzalez, Michelle M., PE -- Publications by Franklin, Daniel G., CIRM, CxA -- Publications by Miller (Co-Lead), Steven, R. -- Publications by Foss, Mark (Co-Lead) -- Publications by Newton (Co-Lead), Mark -- Publications by Sumner, Philip, PE -- Publications by Freeman, Rod -- Publications by Derrett, Christopher --...