Quality control is an essential operation of the pharmaceutical industry. Drugs must be marked as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation. Quality control in the pharmaceutical industry is required for raw materials, API, packaging materials and finished products. This course aims to explore the bioassays, quality control of vaccines, alkaloidal drug assays, determination tests and statistical interpretation of QC charts.
COURSE LEARNING OUTCOMES (CLO)
CLO: 1. To describe biological assays of different products, alcoholometric methods, miscellaneous determinations and tests.
CLO: 2. To illustrate quality control measures for vaccines and alkaloidal drugs.
CLO: 3. To interpret statistical process control charts.
- 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.
- QUALITY ASSURANCE OF VACCINES:
- Introduction, Quality measures for stability of vaccines, potency testing, and post market surveillance of vaccines.
- MISCELLANEOUS DETERMINATIONS AND TESTS:
- Determination of weight/ml, Water/Moisture content, Loss on Drying, Evaluation of Ointments, Ash contents and Alkalinity of Glass.
- STATISTICAL INTERPRETATION OF QUALITY CONTROL CHARTS DURING MANUFACTURING PROCESSES: