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Pharmaceutical quality management: PHARMACEUTICS-IX(Pharmaceutical Quality Management-I)

Drug quality managemt simply, as the ability of a product to satisfy stated needs, including identity, strength and purity, without undesired side effects.

course outline

1. INTRODUCTION:

(a) Basic concepts about introduction of pharmaceutical industry in relevance to quality assurance and quality control departments, testing, quality management system, quality assurance, quality control, Standard.
(b) General understanding of good laboratory practices and validation


2. 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 ingredients and dissolution tests of Powders, Granules, Tablets and Capsules

3. QUALITY CONTROL OF SYRUPS AND ELIXIRS:

Viscosity, its determination and application in the Quality Control of Pharmaceuticals, Weight per ml and Assay of active ingredients.
4. QUALITY CONTROL OF SUPPOSITORIES:

Disintegration test, Uniformity of weight, Assay of active ingredients, Liquefaction time test and Breaking test.

5. 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 ingredients.

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