PHARMACEUTICS-VIII (PHARMACEUTICAL QUALITY CONTROL)

PHARMACEUTICS-VIII (PHARMACEUTICAL QUALITY CONTROL)

SCOPE:

1. An understanding of the testing,

2. Quality control program and methods adopted in a pharmaceutical industry.

3. Dosage form control,

4. Process control,

5. Testing program and methods,

6. Physical, chemical and biological tests and specifications,

Statistical quality control.

7. General understanding of Total Quality Assurance and measures to adopt Quality Assurance.

QUALITY CONTROL OF SOLID DOSAGE FORMS:

Physical tests:

Hardness,

Thickness and Diameter,

Friability,

Disintegration,

Weight Variation.

Chemical tests:

Content uniformity,

Assay of active ingredients

Dissolution tests of Powders, Granules, Tablets and Capsules.

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.

EVALUATION OF SUSTAINED ACTION PRODUCTS (TABLETS & CAPSULES):

Stability of viability rate during storage and

In-vitro & In-vivo evaluation of sustaining action.

QUALITY CONTROL OF SUPPOSITORIES:

Disintegration test,

Uniformity of weight,

Assay of active ingredients,

Liquefaction time test and Breaking test.

QUALITY CONTROL OF STERILE PRODUCTS (PARENTERALS):

Leaker’s test,

Clarity test,

Pyrogen test for Parenteral and other sterile preparations and

Assay for active ingredients.

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.

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.

ALKALOIDAL DRUG ASSAY:

Weighing for assay,

Extraction of drugs,

Maceration,

Percolation,

Continuous extraction,

Purification of Alkaloids and

Determination of alkaloids.

MISCELLANEOUS DETERMINATIONS AND TESTS:

Determination of weight/ml,

Water/Moisture content,

Loss on Drying,

Toxicity tests & Identification tests,

Evaluation of Ointments,

Ash contents and Alkalinity of Glass.

GENERAL KNOWLEDGE OF APPENDICES ATTACHED TO B.P, BPC, AND USP.

STATISTICAL INTERPRETATION OF QUALITY CONTROL CHARTS DURING MANUFACTURING PROCESSES.