Implementing New Technology in a Regulated Environment
Over the course of a drug product’s lifetime (as many as 15 to 20 years or more), many significant advances in technology will occur. Implementing new analytical techniques (e.g., capillary electrophoresis) or advances in existing technology (e.g., sub-2-mm particle columns for HPLC) can significantly impact business practices (return on investment) and product quality. However, in a regulated laboratory, implementing new technology can present many challenges. This chapter discusses some industry-accepted practices for implementing new technology, FDA guidance available on the subject, and the process to consider when adopting new technology for use in approved, standard, or validated analytical methods.