Fundamentals of quality control systems and operations in pharmaceutical industry along with principles of quality control, statistical evaluation of the data obtained, statistical methods of analysis relevant to QC activities and regulatory requirements for laboratory operations; the essential aspects of Good Laboratory Practices (GMP) and pharmacopoeia requirements for raw materials sampling and testing, process control, inspection, sampling procedures, finished product release and methods to prevent product failures. (3 credit hours: 2 class hours and 3 practical hours)
