A Regulatory Perspective on Manufacturing Processes Pertaining to Lyophilized Injectable Products.

Freeze-drying, also known as lyophilization, is a dehydration process designed to prolong the shelf life of injectable drug products. Here, we provide regulatory considerations for manufacturing processes specific to lyophilized injectable products. Specifically, a general discussion on each unit operation, including compounding, filtration, filling, and lyophilization, is provided to help the pharmaceutical industry establish reliable manufacturing processes from a regulatory perspective. In addition, a list of manufacturing-related deficiencies identified from a total of 263 new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted for lyophilized injectable products is provided. We hope that the information presented in this report may help applicants avoid some common manufacturing-related deficiencies in regulatory submissions, thereby making high-quality lyophilized pharmaceuticals expeditiously available to the American public.