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)

GENERAL OBJECTIVES:

 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.