1. Phar 620: Pharmaceutical Microbiology
This subject describes the roles and responsibilities of a pharmaceutical microbiology department in pharmaceutical industry. It focuses on:
- Pharmaceutical microbiology quality control;
- Antimicrobial effectiveness testing;
- Microbial examination of non-sterile products;
- Sterility testing;
- Bacterial Endotoxin testing
- Microbiological inspections of drug, biotechnology and medical device manufacturers.
Upon successful completion of this subject the student will be able to:
· Demonstrate an understanding of pharmaceutical microbiology
· Analyze pharmaceutical microbiology QC principles as they apply to various aspects of drug production and testing.
· Implement and conduct the various types of pharmaceutical microbiological inspections and audits used in the pharmaceutical industry.
· Utilize practical experience gained with pharmaceutical microbiological QA systems to solve problems in the industry.
· Identify the importance of quality assurance systems.
· Introduction to Pharmaceutical Microbiology quality control
· Sterility testing
· Bacterial endotoxin testing (BET)
· Microbiological Assay & Bioassays
· Preservative efficacy test
- Hugo and Russell's pharmaceutical microbiology 8th edn., Published:Oxford Blackwell Science, 2004.
- Pharmaceutical microbiology edited by W.B.hugo and.Russel L., 6th Edn, BlackwellScience, 1977.
- Hugo W.B. An Introduction to Microbiology, 2nd ed. London: Heinemann Medical Books 1972.
- Russell A.D. & Chopra I. Understanding Antibacteral Action and Resistance, 2nd edn. Chichester: Ellis Horwood, 1996.
- Collee J.G., Duguid J.P., Fraser A.G. & Marmion B.P. Mackie & McCartney's Practical Microbiology, 13th edn. Edinburgh: Churchill Livingstone 1989.
- Dawes I.W. & Sutherland I.WMicrobial Physiology, 2nd edn. Oxford: Blackwell Scientific Publications. 1991.
- Manager: ramanjireddy brahmareddy