Items related to ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufactur...
This second edition of the ISPE Baseline® guide: Biopharmaceutical Manufacturing Facilities intends to further reinforce the concepts described in the first edition of the Guide, provide examples of how these concepts can be put into practice, and detail the value and benefits of the approach described. The biopharmaceutical industry has adapted to reflect available technologies, products with more focused patient populations, regulatory conditions, and continued pressures on costs. The Guide develops concepts to reflect how these changes affect Biopharmaceutical Facilities without sacrificing product quality, by reducing risk and enhancing the manufacturing control strategy. The Guide emphasizes the use of closed systems as an approach to mitigating risks associated with the production of biopharmaceuticals. Concepts presented within the Guide apply to different scales of operation, from individual liters to tens of thousands of liters. The Guide applies to new Clinical and Commercial CGMP production facilities for the development and manufacture of biopharmaceutical Active Pharmaceutical Ingredients (or Drug Substances).
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- ISBN 10 1936379651
- ISBN 13 9781936379651
- BindingPaperback
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