Course Overview

In recent times, advanced new drug design, production processes and sophisticated analytical instrumentation have added new dimension to the complexity of industrial pharmaceutical production process leading to the necessity of extensive and in-depth implementation of QA (Quality Assurance). Thus the course has been designed to familiarize students with GMPs, ICH guidelines, calibration, validation, documentation etc. as new regulations and legislation concerning product quality requirements in pharmaceutical industries have increased the responsibilities of the manufacturer for rigorous quality control of the product.