Pharmaceutical Regulatory Processes

Pharmaceutical Regulatory Processes has as its foundation the fundamental chemical principles introduced in Chemistry 1A and 1B and underlying basics of instrumental chemical analysis and synthetic organic chemistry studied in Analytical Methods 1 and Organic Synthesis, respectively. The Unit provides students with training in pharmaceutical laboratory management and presents an overview of current pharmaceutical laboratory practice. Topics covered include occupational health and safety; quality systems including GLP, GMP and accreditation of laboratories; analytical methods and reliability of scientific data; familiarisation with international standards (ICH and FDA) and official methods of analysis (British and US Pharmacopeia).

Assessment includes report writing according to industry standards. For students interested in teaching chemistry this unit along with Drug Testing and Analysis extends the minimum requirements (see four units mentioned above) and gives a working insight into more advanced chemistry and industry specific practice.