Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes

Process Validationin Manufacturing of Biopharmaceuticals, Third edition

Volumn , Issue , 2012, Pages 51-62

  Seely, Robert J ^a   Haury, John ^a  

^a AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84979154406     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1201/b12013-7     Document Type: Chapter

References (10)

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3. McDermott, R. E., R. J. Mikulak, and M. R. Beauregard. The Basics of FMEA. Portland, OR: Productivity, 1996.
4. Shani, A. “Using Failure Mode and Effect Analysis to Improve Manufacturing Processes.” Med. Device Diagn. Ind. (July 1993): 47-51.
5. Ayyub, B. M. Risk Analysis in Engineering and Economics. Boca Raton, FL: Chapman and Hall/CRC, 2003.
6. Clemen, R. T. Making Hard Decisions, 2nd ed. Pacific Grove, CA: Duxbury Press, 1995, 5-8.
7. Stamatis, D. H. Failure Mode and Effect Analysis: FMEA from Theory to Execution, 2nd ed. Milwaukee, WI: ASQ Quality Press, 2003, 39.
8. Burr, J. T. SPC Tools for Everyone. Milwaukee, WI: ASQ Quality Press, 1993, 8-12.
9. Kieffer, R. G. Validation, “Risk-Benefit Analysis.” PDA J. Pharm. Sci. Technol. 49 (1995): 249-252.
10. Seely, J. E., and R. J. Seely. “A Rational, Step-Wise Approach to Process Characterization.” BioPharm Int. 16 (2003): 24-34.