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By Dao-YaoHe, and Dorit Ron

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Extra resources for Autoregulation of glial cell line-derived neurotrophic

Example text

It took injuries and deaths, mostly involving cross-contamination problems, to convince Congress and the FDA that a revision of the law was needed. The result was the Kefauver–Harris drug amendments, which provided the additional powerful regulatory tool that FDA required to deem a drug product adulterated if the manufacturing process was not acceptable. The first CGMP regulations, based largely on the Pharmaceutical Manufacturers Association’s manufacturing control guidelines, were then published and became effective in 1963.

The choice of procedures and methods to be used to establish validation documentation is left with the manufacturer. This introduction was written to aid scientists and technicians in the pharmaceutical and allied industries in the selection of procedures and approaches that may be employed to achieve a successful outcome with respect to product performance and process validation. The authors of the following chapters explore the same topics from their own perspectives and experience. It is hoped that the reader will gain much from the diversity and richness of these varied approaches.

R. and Nash, R. , Marcel Dekker, New York (1993). 10. Nash, R. , Making the Paper Match the Work, Pharmaceutical Formulation & Quality (Oct/Nov 2000). 11. Guidance for Industry, Scale-Up & Postapproval Changes, CDER, FDA (Nov 1995). 12. , An integrated approach to process validation, Pharm. Eng. 14(3) (1994). 13. Farkas, D. , Unit operations optimization operations, CHEMTECH, July 1977. 39 Copyright © 2003 Marcel Dekker, Inc. 14. Nash, R. , Streamlining Process Validation, Amer. Pharm. Outsourcing May 2001.

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Autoregulation of glial cell line-derived neurotrophic by Dao-YaoHe, and Dorit Ron

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