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 90 of 92
For the most current and official copy, check QMiS.
61
Steam in place
2013
12. Books and Commercial Trade reports:
a. ASM, Manual of Clinical Microbiology;
b. Disinfection, Sterilization, and Preservation, by S Block; Bergey’s
manual systematic Bacteriology
c. Remington’s Pharmaceutical Sciences
d. F-D-C Monthly Reports
Excellent summary of conferences, FDA regulation changes, Key Industry
personnel and often a list of the most recent Product Recalls and regulatory
actions by FDA. Need to sign up for email membership. Instructions for
membership enrollment are available at FDA website below.
(
http://inside.fda.gov/Library/ElectronicResourcesWebLERN/Alphabeticallist/in
dex.htm
)
The “Gold Sheet”- Pharmaceutical & Biotechnology Quality Control The “Pink
Sheet”- Prescription Pharmaceuticals and Biotechnology The “Gray Sheet”-
Medical Devices Diagnostics & Instrumentation The “Silver Sheet”- Medical
Device Quality Control reports
13. Free Trade publications available on line-
Pharmaceutical Technology (
www.pharmtech.com
)
Controlled Environments (
www.cemag.us
)
American Pharmaceutical Review (
www.americanpharmaceuticalreview.com
)
International BioPharm (
www.biopharminternational.com/
)
XIV. Professional memberships
These organizations have available searchable references.
International Society of Pharmaceutical Engineers (
www.ispe.org
)
American Society for Microbiology (
www.asm.org
)
Parenteral Drug Association (
www.pda.org
)
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