PHARMACEUTICS-VI (PHARMACEUTICAL QUALITY
MANAGEMENT) (Theory)
Paper 5 Marks
100
1.
INTRODUCTION:
Basic concepts and introduction of
pharmaceutical industry in relevance to quality control departments, Testing, Quality Management System, Quality
Assurance, Good Manufacturing Practices and Current Good Manufacturing
Practices. General understanding of good laboratory practices and validation.
2.
QUALITY CONTROL OF SOLID DOSAGE
FORMS
(conventional and modified release dosage forms):
(a)
Physical tests: Hardness,
Thickness, Diameter, Friability, Disintegration, Weight Variation.
(b)
Chemical tests: Content uniformity,
Assay of active Ingredient.
3.
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.
4.
QUALITY CONTROL OF SUPPOSITORIES: Dissolution test, Uniformity of
weight,
Assay of active Ingredient,
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 Ingredient.
6.
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.
7.
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.
8.
ALKALOIDAL DRUG ASSAY: Weighing for assay, Extraction of drugs, Maceration,
Percolation, Continuous
extraction, Purification of Alkaloids and determination of alkaloids.
9.
QUALITY ASSURANCE OF VACCINES: Introduction, Quality measures for
stability of vaccines, potency testing, and post market surveillance of
vaccines.
10. MISCELLANEOUS DETERMINATIONS AND TESTS: Determination of weight/ml,
Water/Moisture content, Loss on
Drying, Evaluation of Ointments, Ash contents and Alkalinity of Glass.
11. STANDARDIZATION OF PHARMACEUTICALS: An understanding of quality assurance system adopted in
pharmaceutical industry. Good Manufacturing Practices and Current Good
Manufacturing Practices.
12. STATISTICAL INTERPRETATION OF QUALITY CONTROL CHARTS DURING MANUFACTURING PROCESSES:
Comments
Post a Comment