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By Robert A. Nash, Alfred H. Wachter

Stevens Institute of expertise, Hoboken, NJ. information suggestions to set up applicable validation protocols and behavior method validation assignments, display screen and try particular production tactics for compliance with layout limits, and extra.

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Copyright © 2003 Marcel Dekker, Inc. 14. Nash, R. , Streamlining Process Validation, Amer. Pharm. Outsourcing May 2001. 15. , What is Total Quality Control? The Japanese Way, Prentice-Hall, Englewood Cliffs, NJ (1985). 16. Nash, R. /Nov. 2001. 17. CGMP: Amendment of Certain Requirements, FDA Federal Register, May 3, 1996. 18. Box, G. E. and Hunter, J. Y. (1978). 19. Hendrix, C. , What every technologist should know about experimental design, CHEMTECH (March 1979). 20. Chapman, K. , The PAR approach to process validation, Pharm.

And Schwartz, J. , Marcel Dekker, New York (1990). 8. Nash, R. , Product formulation, CHEMTECH, (April 1976). 9. Pharmaceutical Process Validation, Berry, I. 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.

Prospective Process Validation In prospective process validation, an experimental plan called the validation protocol is executed (following completion of the qualification trials) before the process is put into commercial use. Most validation efforts require some degree of prospective experimentation to generate validation support data. This particular type of process validation is normally carried out in connection with the introduction of new drug products and their manufacturing processes. The formalized process validation program should never be undertaken unless and until the following operations and procedures have been completed satisfactorily: 1.

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