Deficiencies in CM and RTRT-D NDA Submissions

CDER researchers have identified several common deficiencies found in regulatory submissions involving the use of continuous manufacturing (CM) and/or real-time release testing for dissolution (RTRT-D). Writing in the Journal of Pharmaceutical Sciences, the researchers say their intent is to provide recommendations for best practices that will help advance the field by:

• generating greater opportunities for drug applicants to benefit from the implementation of advanced manufacturing approaches;
• improving high-quality regulatory submissions involving CM and RTRT-D and thus
• lessening the regulatory review burden.

“A starting point for developing a robust and credible RTRT-D is an optimal dissolution method whose behavior is plausible and discriminating with respect to as many critical material attributes and critical process parameters as possible,” the researchers write. “In this context, developing a clinically relevant dissolution method would be ideal.”