BACKGROUND AND INTRODUCTION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 15

3. FDA, Medical Devices: Current Good Manufacturing Practices (CGMP) Final Rule;
Quality Systems Regulation, Preamble, Federal Register, 61(195), 52,602-52,662,
October 7, 1996.
4. 21 CFR 820.30 (g).
5. 21CFR120, Hazard Analysis and Critical Control Point (HACCP) System.
6. Department of Health and Human Services, U.S. Food and Drug Administra-
tion, Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach Final
Report—Fall 2004, September 2004.
7. Department of Health and Human Services, U.S. Food and Drug Administration,
Guidance for Industry, Q9 Quality Risk Management, 2006.
8. Department of Health and Human Services, U.S. Food and Drug Administration,
Warning Letter to Bell-More Laboratories, Inc., January 5, 2007.
9. Technical Report 44, Quality Risk Management of Aseptic Practices, PDA Journal
of Pharmaceutical Science and Technology, 2008 Supplement Volume 62, No. S-1.
10. Department of Health and Human Services, U.S. Food and Drug Administration,
Guidance for Industry on the General Principles of Process Validation, January 2011.
11. Department of Health and Human Services, U.S. Food and Drug Administration,
Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing,
September 2004.
12. PDA Submits over 400 Comments on FDA Draft Revised Validation Guidance, PDA
Letter, Volume XLV, Issue #3, March 2009.
13. International Society for Pharmaceutical Engineering ISPE Baseline ® , Pharmaceu-
tical Engineering Guide Series, Volume 5—Commissioning and Qualification, First
Edition, March 2001.
14. ASTM (American Society for Testing and Methodology) E2500-07, Standard Guide
for Standard Guide for Specification, Design, and Verification of Pharmaceutical and
Biopharmaceutical Manufacturing Systems and Equipment.
15. Heparin Issue Reference China may be Source of Tainted Heparin, Associated Press,
March 5, 2008, www.msnbc.msn.com.
16. ISO 14971:2000—Application of Risk Management to Medical Devices.
17. Department of Health and Human Services, U.S. Food and Drug Administration,
Guidance for Industry, Q9 Quality Risk Management, 2006.