BioPharm International-10-01-2001

by Ludwig Huber at Agilent Technologies GmbH and Rory Budihandojo To comply with 21 CFR Part 11, your networked systems require the same validation and qualification steps as those for a single computer. Shared servers and multiple access also add requirements that are unique to networks. Italicized words in this article are defined in the "The Glossaryy" on the last page of the online version.

by Robert J. Seely, Louis Munyakazi, and John Haury Regulatory approval and successful manufacturing depend on establishing meaningful and reasonable acceptance criteria for process validations and ongoing monitoring. Three methods are presented here to correct for the likely underestimation of process limits due to small samples.

by David G. Jensen Your best people will be targeted.

by Steven Ford and William E. Tente Chimeric Therapies, Inc. Manufacturing processes for murine monoclonal antibodies (mMABs) used in therapeutic applications must address more safety concerns than those used for in vitro diagnostics. Adequate characterization helps ensure that the mMAb retains its functional integrity after more extensive processing.

by Jill Wechsler Terrorist attack may postpone health policy legislation but encourage antibioterrorism initiatives.

by Jim Miller