Prevention of Microbial Contamination - Pharmaceutical Technology

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Prevention of Microbial Contamination
A holistic approach to establishing robust control measures.


Pharmaceutical Technology
Volume 35, Issue 6, pp. 62-65

References

1. D. Ariely, "On Empathy and Emotion," in Why We Respond to One Person Who Needs Help but Not to Many (HarperCollins Publishers, New York, NY, 2010), pp. 237-256.

2. Gregory Roumeliotis, "FDA Report Sheds Light on Chiron's Problems," http://Outsourcing-Pharma.com/, (July 2006).

3. John George, Phil. Bus. Jrnl. (January 2011).

4. R.M. Donlan, Emerg. Infect. Dis. 7 (2) 277–281 (2011).

5. J. Glausiusz, "Your Body is a Planet," Disc. Mag. (June 2007).

6. USP 32–NF 27 General Chapter <1072>, "Disinfectants and Antiseptics" (USP, Bethesda, MD), pp. 576–580.

7. European Commission, "Medicinal Products for Human and Veterinary Use, Annex 1, Manufacture of Sterile Medicinal Products," Rev., Guidelines to Good Manufacturing Practice (Brussels, Belgium, Nov. 2008).

8. GMP Trends #734, (GMP Trends, Inc., Boulder, CO, Aug. 15, 2007), p. 2.

9. S.S. Block, "Fundamental Principles of Activity" in Disinfection, Sterilization, and Preservation (Lippincott Williams & Wilkins, Philadelphia, PA, 5th ed., 2001), pp. 31–79.

10. GMP Trends #631 (GMP Trends, Inc., Boulder, CO, May 1, 2003), p. 4.

11. FDA, Warning Letter NEW-16-08 W, Issued Jul. 2, 2008, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048221.htm, accessed Jan. 19, 2011.


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