COURSE NO : Industrial Pharmacy 131
COURSE TITLE : Quality Assurance of Pharmaceuticals
COURSE DESCRIPTION : Quality systems approaches applied to the pharmaceutical industry
CREDIT UNITS : 3 units (1 lec, 1 dry lab, 1 wet lab)
PREREQUISITE/S/CO-REQUISITES : Pharm Chem 136 (Pharmaceutical Analysis 2) and IP 125 (Pharmaceutical Manufacturing)
At the end of the course, the student should be able to:
Demonstrate the ability to research and solve problems associated with industrial pharmacy practice, as applied to the quality assurance of pharmaceuticals.
Specifically, the student should be able to:
1. Describe the most up-to-date concepts of quality assurance and quality systems approaches;
2. Identify the current trends in good manufacturing practice and pharmaceutical quality control;
3. Comply with the latest requirements in pharmaceutical regulatory affairs;
4. Integrate statistical methods in the analysis of drug product quality;
5. Apply the principles involved in the quality control testing of raw materials and drug delivery systems; and
6. Evaluate the physico-chemical properties of both raw materials and finished products, to come up with pharmaceutically acceptable products.