BioPharm International-03-15-2002

by Jill Wechsler, pp. 55-57, 60 The industry must ensure that manufacturing systems can produce high quality and consistent therapies, efforts that may lead to comparable "subsequent entry" products.

by Steven S. Kuwahara, Titan Pharmaceuticals Numerous warning letters and consent decrees have revealed problems in coping with even simple parts of the GMPs.

by Thomas W. Patapoff and David E. Overcashier Genentech, Inc. The freezing method used during lyophilization can substantially affect the structure of the ice formed, the water-vapor flow during primary drying, and the quality of the final product. Controlling how a solution freezes can shorten lyophilization cycles and produce more stable formations.

by Heather B Hayes, a freelance writer, and Jim Miller, publisher of the Bio/Pharmaceutical Outsourcing Report EVA allows project managers to refer to tangible numbers, not just a gut feeling, in determining whether a project is advancing on time and within budget.

by Mary Jo Veverka Accenture Significant amounts of time and effort are spent on validating computer systems. Companies that want efficient, high-quality systems can avoid considerable consts by incorporating CSV capabilities throughout systems development.

by Archie Lovatt, Donna McMutrie, John Black, and Iain Doherty Q-One Biotech Ltd. Real-time quantitative PCR has revolutionized the detection and quantification of viral contaminants. Quantitative PCR assays can detect noncytopathic viruses that have recently become a concern in testing for biopharmaceutical safety. High versatility reproducibility, and throughput of such assays decrease the time spent in development, testing, and regulatory compliance.

by Christopher L. Gent Pharmacia Corporation Validation is required for computer systems used to create, modify, maintain, archive, retrieve, or transmit data intended for submission. To ensure that the QA/QC and the IT departments speak the same language, a system developer will build documented evidence that a system's functionality has been tested, performs as specified, and generates reproducible results.

Even more information on electronic document tracking and management.

by Robert Zeid TLI Development The corporate fantasy where everyone knows all the systems all too often collides with a nightmare reality where all the systems are known by only a few. Any specification or manufacturing change that affects various departments can quickly become a bewildering morass of proposed, actual, and implemented changes ? with few connections to actual lots and practices. Draw a line in the CMC "sand" where those changes actually began.