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

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