Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation. Quality control in the pharmaceutical industry is required for raw materials, API, packaging materials and finished products. This course focuses on introduction to good manufacturing practices, quality control of solid, liquid and sterile dosage forms along with standardization techniques.
COURSE LEARNING OUTCOMES (CLO)
CLO: 1. To describe the core concept of quality control and importance of GLP and GMP in pharmaceutical industry.
CLO: 2. To explain quality control methods for different pharmaceutical preparations.
CLO: 3. To analyze quality assurance system adopted in pharmaceutical industry to assess quality reliability of products.
- 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.
- General understanding of good laboratory practices and validation
- QUALITY CONTROL OF SOLID DOSAGE FORMS:
- Physical tests: Hardness, Thickness and Diameter, Friability, Disintegration, Weight Variation.
- 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 assurance system adopted in pharmaceutical industry. Good Manufacturing Practices and Current Good Manufacturing Practices.