Course Contents

INTRODUCTION: (a) Basic concepts and introduction of pharmaceutical industry in relevance to quality assurance and quality control departments, testing, quality management system, quality assurance, quality control and quality standards. (b) General understanding of good laboratory practices and validation QUALITY CONTROL OF SOLID DOSAGE FORMS: (a) Physical tests: Hardness, Thickness and Diameter, Friability, Disintegration, Weight Variation. (b) Chemical tests: Content uniformity, Assay of active Ingredient and dissolution tests of Powders, Granules, Tablets and Capsules. QUALITY CONTROL OF SYRUPS, ELIXIRS and DISPERSE SYSTEM: Viscosity, its determination and application in the Quality Control of Pharmaceuticals, Weight per ml and Assay of active Ingredient. QUALITY CONTROL OF SUPPOSITORIES: Dissolution test, Uniformity of weight, Assay of active Ingredient, Liquefaction time test and Breaking test. QUALITY CONTROL OF STERILE PRODUCTS (PARENTERALS): Sterility Test and Sterile section management, Leaker’s test, Clarity test, Pyrogen test for Parenteral and other sterile preparations, Assay for active Ingredient. STANDARDIZATION OF PHARMACEUTICALS: An understanding of quality assurence system adopted in pharmaceutical industry. Good Manufacturing Practices and Current Good Manufacturing Practices. BIOLOGICAL ASSAYS: Biological methods, Standard preparations and units of activity, Bioassay of antibiotics, Bioassay of insulin injection, Assay of prepared digitalis and Assay of Vitamin D. ALCOHOL DETERMINATION: Alcoholometric methods, Problem during distillation of alcohol, Method for liquids containing less than 30% or more than 30% alcohol and special treatment before distillation. ALKALOIDAL DRUG ASSAY: Weighing for assay, Extraction of drugs, Maceration, Percolation, Continuous extraction, Purification of Alkaloids and determination of alkaloids. QUALITY ASSURANCE OF VACCINES: Introduction, Quality measures for stability of vaccines, potency testing, and post market surveillance of vaccines. MISCELLANEOUS DETERMINATIONS AND TESTS: Determination of weight/ml, Water/Moisture content, Loss on Drying, Evaluation of Ointments, Ash contents and Alkalinity of Glass. STATISTICAL INTERPRETATION OF QUALITY CONTROL CHARTS DURING MANUFACTURING PROCESSES:

Course Synopsis

To get consistency in various dosage forms including liquid, solid and semisolids by applying various quality control, quality assurance tools and cGMP guidelines. Students will learn validation of analytical procedures and their applications both at processing and finished levels.

Course Learning Outcomes

Overall aims of course is to develop basic understanding in the area of pharmaceutical manufacturing to maintain their quality not at the various processing stages but also through their shelf life.