Page 2 - Quality control of pharmaceuticals (07-PA 704) practical

Microbiological Quality Control

I. INTRODUCTION TO MICROBIOLOGICAL QUALITY CONTROL IN
PHARMACEUTICAL INDUSTRIES ....................................................................................... 2
II. PREPARATION AND STERILIZATION OF DIFFERENT CULTURE MEDIA:............. 4
III: SUBCULTURING OF BACTERIA & FUNGI ................................................................... 6
IV. MICROBIOLOGICAL ASSAY OF ANTIBIOTICS BY CUP PLATE METHODS ......... 8
V. STERILITY TESTING OF PHARMACEUTICALS.......................................................... 12
VI. BACTERIAL ENDOTOXIN TEST METHODS .............................................................. 15
VII. MICROBIAL LIMIT TESTS............................................................................................ 16
VIII. VIABLE ENVIRONMENTAL MONITORING............................................................. 20
REFERENCES: ........................................................................................................................ 22
APPENDIX: SELECTED USP CHAPTERS........................................................................... 23

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