Description of the Course of Pharmaceutical Microbiology and Quality Management
| Course Title: | Pharmaceutical Microbiology and Quality Management |
| Course No: | MB 303 (Elective I) |
| Nature of the Course: | Theory |
| Full Marks: | 50 |
| Pass Marks: | 17.5 |
| Year: | Third years (3rd) |
| Total Lecture Hours: | 75 |
Course Objectives
After completion of the course, the students will be able to:
a) Understand applications of microbiology and quality control systems in pharmaceutical and food
industries
Course Contents of Pharmaceutical Microbiology and Quality Management
Course Contents Pharmaceutical Microbiology and Quality Management
| S.N | Topic/ Chapter Name | Credit Hours |
| 1. | Introduction of Pharmaceutical Microbiology Definition, scope, objectives, application of microorganisms in pharmaceutical science | 5 hrs |
| 2. | Antimicrobial Agents Definition, sources, types, target and mode of action of antibiotics, antiviral, antiparasitic and antifungal drugs, drugs in combination | 15 hrs |
| 3. | Quality Evaluation of Pharmaceutical Products Bioassays, chemical assays, immunoassay of antibiotics, quality evaluation of disinfectants, antiseptics and preservatives | 15 hrs |
| 4. | Microbial Spoilage and Preservation of Pharmaceutical Products Types of spoilage, factors affecting microbial spoilage, preservation of pharmaceutical products, physical, chemical and biological indicators of sterilization, principles and methods of sterility testing | 15 hrs |
| 5. | Quality Assurance and Quality Management Principles of quality risk management, quality risk management process, risk assessment, risk control and communication, risk management methodology and tools, hazard analysis and critical control points (HACCP), quality risk management for facilities, equipment and utilities, good hygiene practices (GHP), good manufacturing practices (GMP), good laboratory practices (GLP), quality management systems – ISO9001, ISO 22000, safety and quality auditing of the food and pharmaceutical products, quality assurance | 20 hrs |
| 6. | Food Safety and Consumer Protection Microbiological hazards, chemical hazards, food adulteration, genetically modified organisms and novel foods, sanitary and phytosanitary measures | 5 hrs |
| 7. | Total | 75 hrs |
Recommended Readings
Text books
- Denyer SP, Hodges NA and Gorman SP (Eds) (2004). Hugo and Russell’s Pharmaceutical Microbiology, 7th Edition, Blackwell Science Ltd.
- WHO (2007). Quality Assurance of Pharmaceuticals, Volume 2, 2nd Edition.
Reference books
- Tripathi KD (2009). Essentials of Medical Pharmacology, 6th Edition, Jaypee Brothers, New-Delhi
- Laurence DR, Bennette PN and Brown MJ (1997). Clinical Pharmacology, 8th Edition, Churchill Livingstone
- US Pharmacopia
- British Pharmacopia