Drug Specification Development for APIs and Drug Products Training Course :

The course will present a review of the activities that will occur in the process of setting specifications for APIs made by synthesis or conventional fermentation. Critical specification issues for drug substances and drug products will be reviewed, specifically focusing on the interactions and dialogue necessary between analytical and pharmaceutical/ chemical groups during the development of specifications. Using practical examples, the importance of understanding “real-life” constraints and regulatory requirements will be highlighted across a wide variety of drug product formulations. Strategies for Out-Of-Specification (OOS) findings will be discussed. The course will review the latest activities of ICH with respect to specifications for drug substances and drug products. You will benefit in your job by applying facts learned in this course. Increases in productivity will result. An open and interactive environment is encouraged throughout the course.