Semester II

1.      Phar 620: Pharmaceutical Microbiology

Course objectives

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.

 

Learning Outcomes

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

 

 

Suggested references

1. Hugo and Russell's pharmaceutical microbiology 8^th edn., Published:Oxford Blackwell Science, 2004.
2. Pharmaceutical microbiology edited by  W.B.hugo and.Russel L., 6^th  Edn, BlackwellScience, 1977.
3. Hugo W.B. An Introduction to Microbiology, 2nd ed. London: Heinemann Medical Books 1972.
4. Russell A.D. & Chopra I. Understanding Antibacteral Action and Resistance, 2^nd edn. Chichester: Ellis Horwood, 1996.
5. Collee J.G., Duguid J.P., Fraser A.G. & Marmion B.P. Mackie & McCartney's Practical Microbiology, 13th edn. Edinburgh: Churchill Livingstone 1989.
6. Dawes I.W. & Sutherland I.WMicrobial Physiology, 2nd edn. Oxford: Blackwell Scientific Publications. 1991.