Abstract

Development of Scientifically Sound Control Strategy for Drug Substance

Sushil Srivastava, Process Research and Development Director, Bristol-Myers Squibb

Drug substance synthesis involves multiple steps, thus each step in the synthesis from starting materials need critical evaluation. A risk based approach will be discussed for efficient development of the DS control strategy. The following topics will be covered. •Identification of Critical Quality Attributes of the drug substance •Understanding of formation and purge of the impurities •Identification and control limits of parameters impacting quality •Setting up appropriate specifications for SMs and intermediates to ensure quality •Verification of control strategy •Defining the scientifically sound control strategy