Pharmaceutical Microbiology

Infectious diseases and pathogenesis. Production and storage of water. Quality determination. Parenteral products. Pyrogens and pyrogen testing.  Evaluation of microbial contents of Pharmaceutical Preparations and products. Sources of Microbial contamination of Pharmaceuticals. Hospital and factory hygiene. Quality determination using microbiological techniques. Sterilization techniques. Sterile Pharmaceutical products. General principle of spoilage and preservation against biodegradation. Raw materials quality. Water and its purity. In-process microbiological controls. Quality Assurance of finished products. Limiting number of viable organisms. Principles of preservation of multiphase systems. Factory and Hospital hygiene. Code of Good Pharmaceutical Manufacturing Practice (GPMP). Fundamentals of industrial fermentation. Use of microorganisms in biotechnology. Search for cultures. Approaches in strain development. Genetic/enzymatic engineering techniques. Selective isolation of mutants. Maintenance and preservation. Media development and processing. Fermentation and product recovery. Isolation of bacteria and fungi for use in Pharmaceutical industry. Primary and secondary metabolites. Clinical trials registration. Intellectual property and patent rights of biotechnological products.