KIM 558 - Introduction to Pharmaceutical Industry

Course Objectives

I. To give information about the techniques, methods and concepts used in pharmaceutical industry
II. To give information about regulations in the API production
III. To give information about Polymorphism and relationship between polymorphism and active . pharmaceutical ingredients(API)
IV. To inform about Patents and practice in the pharmaceutical industry
V. To give information about Drug Master File and its preparation

Course Description

General informations, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Patents and Applications in the Pharmaceutical Industry, Polymorphism in the Active Pharmaceutical Ingredients (API), ICH guidelines(Limits, Force Degradation Studies (FDS), Classification of Areas, Stability, Drug Master File (DMF), Pharmacopeias (USP, EP, JP), Validations (Process, Method), Process Risk analysis