ASEPTIC PROCESSING: TWO - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 266

14. A risk management standard. Available at http://www.theirm.org/. 2002.
15. ISO 31000. Guidelines on principles and implementation of risk management. 2009.
16. ICH Q9 Quality risk management. Available at http://EMEA/INS/GMP
/157614/2005-ICH, http://www.emea.eu.int/pdfs/human/ich/15761405en.pdf#search=
ich%20q9. 2005.
17. Guidance for Industry. Sterile products produced by aseptic processing-current good
manufacturing practice, US FDA, September. 2004.
18. FDA risk pharmaceutical cGMPs for the 21st century: a risk-based Approach, US
FDA. 2004.
19. Tidswell EC, McGarvey B. Quantitative risk modeling in aseptic manufacture. PDA
J Pharm Sci Technol 2006;60(5):267-283.
20. Langille S, Ensor L, Hussong D. Quality by design for pharmaceutical microbiology.
Am Pharm Rev 2009;12(6):80-85.
21. Hillson D. Business uncertainty. Threat or opportunity. Ethos 1999;13:14-17.
22. Sandal T. An approach for the reporting of microbiological results from water systems.
PDA J Pharm Sci Technol 2004;58(4):231-237.
23. Akers J, Agalloco J. Risk analysis for aseptic processing:

the Ackers-Agalloco

method. Pharm Technol 2005;29(11):74-88.
24. Whyte W, Eaton T. Microbial risk assessment in pharmaceutical cleanrooms. Eur J
Parenter Pharm Sci 2004;9(1):16-23.
25. Tidswell EC. Bacterial adhesion: considerations within a risk-based approach to clean-
ing validation. PDA J Pharm Sci Technol 2005;59(1):10-32.
26. Agalloco J, Akers J. Validation of aseptic processing. In: Agalloco J, Carleton FJ,
editors. Validation of Pharmaceutical Processes. 3rd ed., InformaUSA, New York,
2007:317-326.
27. Tidswell EC, McGarvey B. Quantitative risk modeling assists parenteral batch dispo-
sition. Eur J Parenter Pharm Sci 2007;12(2):3-7.
28. WHO expert committee on specifications for pharmaceutical preparations. WHO
Technical Report Series 908, World Health Organization, 99-112. 2003.
29. ISO 14971:2007(E). Medical devices - application of risk management to medical
devices. 2007.
30. Tidswell. Risk-based approaches facilitate expedient validations for control of
microorganisms during equipment cleaning and hold. Am Pharm Rev 2005;8(6):
28-33.
31. Akers J, Agalloco J. The simplified Akers-Agalloco method for aseptic processing
risk analysis. Pharm Technol 2006;30(7):60-76.
32. Ljungqvist B, Reinmuller B. Risk assessment with the LR-Method. Eur J Parenter
Pharm Sci 2002;7(4):105-109.
33. Ackers J. Development of Highly Automated PAT-Compatible Aseptic Processing
System. Biaritz, France: A3P Congress; 2004.
34. United

States Pharmacopoeia. Available at http://www.uspnf.com

/uspnf/login?bypass=false. 2010.
35. European Pharmacopoeia. Available at http://online6.edqm.eu/ep607/. 2010.
36. Pharmacopoeia of the people's Republic of China. 2005.
37. Japanese Pharmacopoeia. Available at http://jpdb.nihs.go.jp/jp14e/. 2001.