Evidence Based India

 What is fermentation technology? By: Azim Shaikh M.Sc Biotechnology  B.Sc Biochemistry (Gold Medal) Before the industrialization began, the term fermentation refers to any biological processes occurred due to the action of anaerobic microorganism. But in modern world, the fermentation encompasses all the process that are employed to obtain desired product.  Antibiotics, hormones, therapeutic proteins, nutritive supplements such as dried yeast etc. are prepared through fermentation production.  The advantages of fermentation over normal chemical synthesis of drugs and cosmetics Chemical synthesis also called as traditional way of drug manufacturing requires expensive raw materials such as irreplaceable precursors which usually increase the production cost of that drug. Some precursor chemicals are hard to obtained hence many manufacturer faces transportation issue. Fermentation employs cells (such as bacteria or fungi) or part of cells such as enzymes, specific prote...

 Quality Assurance in the Pharmaceutical Industry: A Comprehensive Guide By: Azim Shaikh M.Sc Biotechnology  B.Sc Biochemistry (Gold Medal) Table of Contents Sr. No. Chapter Content   1   Introduction to Quality Assurance in the Pharmaceutical Industry - Overview - Importance of Quality Assurance - Structure of the Book   2     The Role of the QA Department - Responsibilities and Functions   - Interaction with Other Departments     3   Licensing and Regulatory Requirements - FDA and EMA Regulations   - cGMP Compliance   - ISO Standards   4   Key Concepts in Quality Assurance - Quality Control vs. Quality Assurance   - Risk Management   - Validation and Verification   ...