BioPharm International-10-01-2002

by Jill Wechsler Agency officials are reexamining manufacturing standards and plant inspection processes.

by Gail Sofer, BioReliance The latest installment of our series on recently published methods for inactivating viruses reviews the literature on virus inactivation in plasma and plasma products by chemical treatments, gamma and UV irradiation, and low-pH treatment.

by Anurag S. Rathore, Joseph F. Noferi, and Edward R. Arling from Pharmacia Corporation, and Gail Sofer, Bioreliance; Peter Watler, Amgen, Inc.; and Rhona O'Leary, Genentech, Inc. The trick to process validation, these industry experts argue, is to understand that it is a process that stretches through the whole product life cycle. Some secrets of success: Take a team approach; focus on the timing of the various stages of validation; avoid some common mistakes; and build your documentation as you go.

by G. Steven Burrill, Burrill & Company Beleagured by bad news since the start of the year, biotech is barely registering a pulse on Wall Street . . . but it's hardly time to write the industry's obituary.

by Barbara W. Unger, Don Hill Associates, Inc. Rarely do manufacturers of biologics need to prepare a Biological Product Deviation Report (formerly called and Error and Accident Report); in fact, few manufacturers ever have to complete one. But all manufacturers need to have an SOP describing how to complete this report, in case it becomes necessary.

by Dan Luedke, Keller Crescent Company FDA labeling regulations protect consumers and ensure product identity.

by Massoud Lavian and Paul W. Allen, Clarkston Consulting When an FDA inspection is imminent, it pays to have a plan. Start by getting your papers in order and your facility in a state of good repair. Train a team to manage interaction with inspectors. Coach your employees on how to answer questions. And don't forget to take notes.

by Jill Wechsler