Assessing and Managing Risks in a GMP Environment - Investing time and resources into conducting a risk assessment on a process or product can have a variety of benefits. Save your firm from

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Assessing and Managing Risks in a GMP Environment
Investing time and resources into conducting a risk assessment on a process or product can have a variety of benefits. Save your firm from regulatory headaches by making risk management part of its culture.


BioPharm International


16. Columbia Accident Investigation Board, Report, Volume I, Chapter 7. US Government Printing Office. 2003 August.

17. Battele Columbus Division for The Center for Chemical Process Safety of the American Institute of Chemical Engineers. Guidelines for hazard evaluation procedures. New York: AIChE; 1985.

18. Henley EJ, Kumamoto H. Probability risk assessment. New York: IEEE Press; 1992.

19. Ibid.

20. Kieffer RG, Bureau S, Borgmann A. Applications of failure mode effect analysis in the pharmaceutical industry. Pharmaceutical Technology Europe. 1997 Sept. (vol 9, no 8.) :36-49.

21. FDA/USDA/NACMCF: HACCP principles and application guidelines, Adopted 1997 Aug. 14. Available at http://vm.cfsan.fda.gov/~comm/nacmcfp.html.

22. DeSain C, Sutton, C. Process hazard analysis and critical control point identification. BioPharm Int'l. 2000; 13(10):36-40.

23. US Air Force. Air Force Safety Agency. System safety handbook (Revised July 2000). Kirkland AFB New Mexico: US Air Force; 2000.

24. Canadian Standards Association. Risk management: guideline for decision-makers. CAN/CSA -Q850-97, Rexdale Ont. 1997 Oct.


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