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 87 of 92
For the most current and official copy, check QMiS.
n. Guide to Inspections of Sterile Drug Substance Manufacturers,
(7/1994)
o. Guide to Inspections of Topical Drug Products (7/1994)
p. Guidance for Industry- Submission Documentation for
Sterilization Process Validation in Applications for Human and
Veterinary Drug Products (11/1994)
q. Guideline for the manufacture of In Vitro Diagnostic Products
(1/1994)
r. Guide to Inspections of Microbiological Pharmaceutical Quality
Control Laboratories (7/1993)
s. Guide to Inspections of High Purity Water Systems, (7/1993)
t. Guide to Inspections of Validation of Cleaning Processes
(7/1993)
u. FDA Biotechnology Inspection Guide, Reference materials and
training aids (11/1991)
v. Guidance for Industry, Pyrogen and Endotoxins Testing:
Questions and Answers (June 2012)
8. Inspectors technical guidance (ITG)-
The following are the ITGs that were written regarding microbiological issues.
a. PYROGENS, STILL A DANGER (1/12/79 Number: 32)
b. HEAT EXCHANGERS TO AVOID CONTAMINATION (7/31/79
Number: 34)
c. REVERSE OSMOSIS (10-21-80 Number: 36)
d. BACTERIAL ENDOTOXINS/PYROGENS (3/20/85 Number: 40)
e. LYOPHILIZATION OF PARENTERALS (4/18/86 Number: 43)
f. WATER FOR PHARMACEUTICAL USE (12/31/86 Number: 46)
g. MICROBIOLOGICAL CONTAMINATION OF EQUIPMENT
GASKETS WITH PRODUCT CONTACT (12/31/86 Number: 48)
9. Miscellaneous FDA Documents and References
This list of references may not be entirely microbiology but very important none
the less.
a. FDA Inspectional Operational Manual
b. FDA Warning Letters and Responses
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