Pharmaceutical Microbiology Manual


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ORA.007 Pharmaceutical Microbiology Manual

F
OOD AND 
D
RUG 
A
DMINISTRATION
 
O
FFICE OF 
R
EGULATORY 
A
FFAIRS
 
Office of Regulatory Science
 
Document Number: 
ORA.007 
Revision #: 02 
Revised: 
25 Aug 2020 
Title:
Pharmaceutical Microbiology Manual 
Page 3 of 92
For the most current and official copy, check QMiS. 
U.S. FDA, Office of Regulatory Affairs 
Office of Regulatory Science 
Office of Medical Products and Specialty Laboratory Operations 
3. Current Editorial Board 
Editor-In-Chief: Angele Smith, ORS Headquarters
Rick Friedman, Center for Drug Evaluation and Research 
Jennifer Gogley, Pacific Southwest Medical Products Laboratory 
Kristy Ford, Detroit Medical Products Laboratory 
Marilyn Khanna, ORS Headquarters 
Mivoyel Jeanpaul, ORS Headquarters 
Sammie La, Pacific Southwest Medical Products Laboratory 
Matthew Silverman, Winchester Engineering and Analytical Center 
Marla Stevens-Riley, Center for Drug Evaluation and Research 
Allison Rodriguez, Winchester Engineering and Analytical Center 
Radhakrishna Tirumalai, United States Pharmacopeia
Theresa To, Winchester Engineering and Analytical Center 
4. Original Authors 
Rhonda Alexander, Southeast Food and Feed Laboratory 
Jasna Braut-Taormina, Northeast Medical Products Laboratory 
Jennifer Brzezinski, Forensic Chemistry Center 
Marie B. Buen-Bigornia, Denver Food and Feed Laboratory 
Rick Friedman, Center for Drug Evaluation and Research 
Jennifer Gogley, Pacific Southwest Medical Products Laboratory 
Andrew Gonzales, Denver Food and Feed Laboratory 
Dennis Guilfoyle (ret), Northeast Medical Products Laboratory 
Lawrence James (ret), Northeast Food and Feed Laboratory 
Marilyn Khanna, ORS Headquarters 
David Lau, San Francisco Food and Feed Laboratory 
Eileen Liu, San Francisco Food and Feed Laboratory 



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