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Pharmaceutical quality management: PHARMACEUTICS-XII (Pharmaceutical Quality Management-II)

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

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Course outline

1. 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.

2. 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.

3. ALKALOIDAL DRUG ASSAY:

Weighing for assay, Extraction of drugs, Maceration, Percolation, Continuous extraction, Purification of Alkaloids and determination of alkaloids.
4. QUALITY ASSURANCE OF VACCINES:

Introduction, Quality measures for stability of vaccines, potency testing, post market surveillance of vaccines.

5. MISCELLANEOUS DETERMINATIONS AND TESTS:

Determination of weight/ml, Water/Moisture content, Loss on Drying, Evaluation of Ointments, Ash contents and Alkalinity of Glass.

6. STATISTICS:

STATISTICAL INTERPRETATION OF QUALITY CONTROL CHARTS DURING MANUFACTURING PROCESSES.

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