Good manufacturing practices for biological products Essay

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Morbidity and Mortality Weekly Report
Supplement / Vol. 61

January 6, 2012

Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories
Recommendations of a CDC-convened,
Biosafety Blue Ribbon Panel

U.S. Department of Health and Human Services
Centers for Disease Control and Prevention

Supplement

CONTENTS
1. Introduction: A Culture of Safety for Diagnostic Laboratories..........2
2. Biological Risk Assessment and Biosafety Guidelines..........................7
3. Fundamental Safety Practices in Diagnostic Laboratories.............. 13
4. Tuberculosis Laboratory............................................................................... 34
5. Autopsy/Necropsy, Surgical Pathology.................................................. 38
6. Parasitology Laboratory............................................................................... 47
7. Mycology Laboratory.................................................................................... 52
8. Virology Laboratory....................................................................................... 55
9. Chemistry Laboratory................................................................................... 66
10. Hematology and Phlebotomy Laboratory.......................................... 68
11. Blood Bank...................................................................................................... 72
12. Veterinary Diagnostic Laboratory.......................................................... 74
13. Storing, Packaging, and Shipping Infectious Substances............. 80
14. Emergency Procedures and Responsibilities..................................... 87
15. Biosafety Education..................................................................................... 91
16. Continuous Quality Improvement......................................................... 94
References.............................................................................................................. 95
Appendix .............................................................................................................102

The MMWR series of publications is published by the Office of Surveillance, Epidemiology, and Laboratory Services, Centers for Disease Control and Prevention (CDC),
U.S. Department of Health and Human Services, Atlanta, GA 30333.
Suggested citation: Centers for Disease Control and Prevention. [Article title]. MMWR 2011;60(Suppl):[inclusive page numbers].

Centers for Disease Control and Prevention

Thomas R. Frieden, MD, MPH, Director
Harold W. Jaffe, MD, MA, Associate Director for Science
James W. Stephens, PhD, Director, Office of Science Quality
Stephen B. Thacker, MD, MSc, Deputy Director for Surveillance, Epidemiology, and Laboratory Services
Stephanie Zaza, MD, MPH, Director, Epidemiology and Analysis Program Office

MMWR Editorial and Production Staff

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