BioPharm International-03-15-2002

BioPharm International

Inside Washington: Biotech Manufacturing ? Obstacle or Opportunity?

March 15, 2002

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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.

Guest Editorial: Warning Letters ? A Symptom?

March 15, 2002

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

The Importance of Freezing on Lyophilization Cycle Development

March 15, 2002

Safer, More Stable Products

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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.

Outsourcing Outlook: Using Earned-Value Analysis for Better Project Management

March 15, 2002

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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.

Business Benefits of Computer Systems Validation

March 15, 2002

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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.

Validation of Quantitative PCR Assays?Addressing Virus Contamination Concerns

March 15, 2002

Safer, More Stable Products

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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.

A System Developer's Approach to Validation

March 15, 2002

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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.

Additional charts for the Zeid article, "Specifications and Manufacturing Change Control"

March 15, 2002

Perspectives in Computer Validation

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Even more information on electronic document tracking and management.

Specifications and Manufacturing Change Control: A Prototypic System for Electronic Document Tracking and Management

March 15, 2002

Perspectives in Computer Validation

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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.