Description and Objectives

Quality control is the day- to-day assessment of all compounding operations. This includes receipt of raw materials, preparation, storage, distribution, patient administration, and analytic testing of the finished product . Aspect of management function that determines and implements the “quality policy”, i.e. the overall intention and direction of an organization regarding quality, as formally expressed and authorized by top management.

Pharmaceutical Quality Management

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, and 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. Statistical interpretation of quality control charts during manufacturing processes.

READINGS

• Principles and Methods of Bioassay (Prof. Ramesh K. Goyal)
• BIOLOGICAL ASSAYS : (81) Antibiotic Microbial Assay(USP 37 NF 27), Insulin Bioassay(USP 37 NF 27), (581) Vitamin D assay ((USP 37 NF 27)
• Bioassay techniques for drug development(Atta-ur-RahmanandM.IqbalChoudharyand William J.Thomsonharwood academic publishers)
• Alcohol determination (611) ALCOHOL DETERMINATION ((USP 37 NF 27)
• Modern Alkaloids by Ernesto Fattorusso and OrazioTaglialatela-Scafati
• ALKALOIDS & ALKALOIDS PLANTS TAREK ISMAIL KAKHIA
• Guidelines for Production and Quality Control of Vaccine
• (660) CONTAINERS—GLASS(USP 37 NF 27), 2.2.32. LOSS ON DRYING(BP 2010), (731) LOSS ON DRYING (USP 37 NF 27), (921) Water determination (USP 37 NF 27), ( 789) Particulate matter in ophthalmic solutions (USP 37 NF 27)
• Mehta DK. British National Formulary (BNF). 54th Ed. Pharmaceutical Press; 2016