- 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.
Practical of the subject shall be designed from time to time on the basis of the above mentioned theoretical topics and availability of the facilities, e.g. Assay of various spirits, tinctures, extracts, syrups and elixirs, Assay of Ointments and suppositories, Assay of tablets and capsules, Test for alkalinity of glass, Determination of alcohol contents in the Pharmaceutical preparations and Pyrogen test. Sterility test, Determination of Ash contents, Determination of Moisture contents, Determination of total solids, Determination of viscosity of syrups, gels, etc., Determination of emulsion types (Note: A minimum of 10 practicals will be performed).