Quality Systems

Sep 01, 2003
BioPharm International
By BioPharm International Editors
The author shares a case example that applies an eight-step structured approach to the front-end engineering of a vaccine R&D fill-and-finish facility project. Assumptions, issues, action items, owner interface, and interdisciplinary coordination are covered to meet the challenges of timing, technology, compliance, and cost.
Sep 01, 2003
BioPharm International
By BioPharm International Editors
Vaccine process development is complex, and so are the documents required before clinical trials begin. Technical writers and editors can effectively coordinate the timely authoring, reviewing, and auditing of regulatory documents, minimizing filing delays.
Sep 01, 2003
BioPharm International
FDA and manufacturers seek to curb bogus drugs, while legislators consider liberalizing import policies to cut pharmaceutical costs.
Sep 01, 2003
BioPharm International
By BioPharm International Editors
Biopharmaceuticals are perceived as being at risk of transmitting spongiform encephalopathies to patients, although there has never been such an incident. Clearance studies such as the one described in this article (using a TSE model) can validate inactivation and enhance confidence in the safety of therapeutics produced using animal-derived cell culture supplements.
Sep 01, 2003
BioPharm International
By BioPharm International Editors
The complex world of international regulations, standards, and guidelines on sterile manufacturing of parenteral products is deciphered and reduced to a set of matrix tables.
Aug 01, 2003
BioPharm International
BioPharm International and Tefen Ltd. have teamed up to provide you with information and tools from the BioPharma Operations Excellence Consortium.
Aug 01, 2003
BioPharm International
In Washington, leaders offer assistance and encouragement, speeding new treatments to market.
Aug 01, 2003
BioPharm International
By BioPharm International Editors
Many companies want to conduct quality assurance activities on the manufacturing floor. But implementation can be held up. Why?
Aug 01, 2003
BioPharm International
By BioPharm International Editors
Process characterization requires a significant commitment of time and resources, but the payoff is better process understanding, improved manufacturing success rates, and avoidance of costly regulatory delays.
Aug 01, 2003
BioPharm International
By BioPharm International Editors
When developing a strategy for using technology in biopharmaceutical manufacturing, include the interaction between automation and business systems and the roles they play in enhancing quality assurance and compliance.
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