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REFERENCES:
❖ PHARMACEUTICAL MANUFACTURING HANDBOOK
(Production and Processes)
SHAYNE COX GAD, PH.D., D.A.B.T.
Gad Consulting Services
Cary, North Carolina
❖ Pharmaceutical Microbiology Manual,
FOOD AND DRUG ADMINISTRATION OFFICE OF REGULATORY AFFAIRS
❖ WHO Technical report:
•Annex2: WHO good practices for pharmaceutical microbiology
laboratories
•Annex6: WHO good manufacturing practices for sterile pharmaceutical
products
❖ Quality assurance of Pharmaceuticals, WHO
❖ Handbook of Microbiological Quality Control
by R Baird & N Hodges
❖ USP
❖ BP
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