2.44903 MEDICINE QUALITY ASSURANCE

The course aims to introduce students to the value of the process of quality assurance and quality control and their significance in the manufacture, storage and distribution of drugs; and to introduce students to the concepts of toxicology and further extend the knowledge of drugs substances. On completion, the student should be able to: demonstrate the skills of organising and carrying out quality assurance and quality control procedures as well as quality control tests and appreciate the significance of same; demonstrate a basic understanding of the general principles of toxicology; and have further expanded their knowledge of the medicinal chemistry of drug substances. Topics include: the code of good manufacturing practices (cGMP); toxicology of drugs and foreign compounds; and assessment of chemical safety.

Contact hours: 6 hours per week (2 Lectures, 1 Tutorial and 3 hour practical).

Assessment: Tests, assignments, practicals (60%), final exam (40%)

Prerequisite: 2.34906

Text:

Becket, A.H. & Stenlake, J.B., 1988, Practical Pharmaceutical Chemistry Parts I and II, 4th edition, Athlone Press, London.