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A Rational Approach for Setting and Maintaining Specifications for Biological and Biotechnology-Derived Products Part 1
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Biopharm International
- Article date:
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June 1, 2008
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Copyright informationCopyright Advanstar Communications, Inc. Jun 2008. Provided by ProQuest LLC. (Hide copyright information)
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ABSTRACT
This paper discusses an approach for the establishment and lifecycle management of biological and biotechnology-derived product specifications. The views presented are consistent with the concept of Quality by Design (QbD), in which critical quality attributes (CQAs) are distinguished from parameters used to monitor process consistency. Specifications and the corresponding limits as applied to CQAs serve to ensure that the product is fit for use, whereas control limits are a manufacturer's tool to monitor shifts and trends in the manufacturing process. In the current paradigm, inappropriate use of specifications creates a disincentive for continuous process understanding; more ...
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