BioPharm International-08-01-2002

by Roby Blasini, Pharmacia Corporation Creating Documents that Meet GMPs and Make Good Business Sense

by Massoud Lavian and Paul W. Allen, Clarkston Consulting Would your company survive a surprise inspection? An FDA inspection can be a nightmare that costs your company money, time, and reputation. Proactive managers understand the logic behind FDA regulations and prepare accordingly. This three-part survival guide to inspections (whether from FDA, a client, an investor, or a European agency) will sharpen your vision of your company?s regulatory compliance picture.

by Gail Sofer, BioReliance Smallest of the parasites, viruses depend completely on other cells (animal, bacterial, or vegetable) for reproduction ? several hundred viruses infect humans. Viruses can be inactivated by extremes of pH, heat, UV, desiccation, antiseptics, disinfectants, and organic solvents among others. The trick is in finding the right antiviral method for a particular virus ? without harming the biological product of interest. With Part 2 of this literature survey, we look at viral inactivation methods for RBCs and platelets.

by Joseph F. Noferi, Edward R. Arling, and Ralph H. Dillon, Pharmacia GS API Biopharma, global supply, and Daniel E. Worden, Worden Enterprises FDA is no longer complacent, punishing noncompliant companies with puny fines, those small slaps at the financial bottom line. FDA?s thunder now includes multimillion dollar fines, permanent injunctions, and prison sentences for senior executives. Companies that emerge as winners in today?s environment are those that treat compliance and risk management with the same flawless planning and execution that they use for their business plans and their financial investments.

PDUFA III boost manufacturer fees to cover postapproval surveillance and streamline the FDA review process

by Kevin McAloon, Morgan Advanced Ceramics

Columns and Departments

August 15, 2002

by Benjamin H. Rudolph, Aptagen, Inc. Having a big name on your team isn't enough, but it sure helps!

by Les Blumberg, The Warren Company, and Jim MIller, Bio/Pharmaceutical Outsourcing Report Strategic Outsourcing requires discipline so companies can realize the competitive benefits in the marketplace

by Demetri Petrides, Alexandros Koulouris, and Charles Siletti, Intelligen, Inc. Bottlenecks are everywhere, from the freeway overpass during the morning commute to the long lines at the supermarket. But bottlenecks in a manufacturing process are bad for business. Computer models can help you eliminate those conditions or situations that retard your progress. Whether the goal is strategic planning, evaluating alternatives, purchasing equipment, appraising a facility, or optimizing production processes, simulation tools can improve your analysis.