Abstract

SUPAC: A REGULATORY APPROACH FOR HIGH QUALITY DOCUMENTATION IN CHEMISTRY, MANUFACTURING AND CONTROL (CMC)

Balasubramanian J.*, P. Naveena, S. Hari Ram, Chenchu Teja Varma Y., Eknath Babu

ABSTRACT

SUPAC is the guidance about the level of changes, recommended chemistry, manufacturing and control tests for each level of change. CMC changes are inevitable due to many reasons including changing needs, new findings and continuous improvement. Therefore, regulations require that all changes be evaluated carefully and follow the proper regulatory path for implementation, regardless of whether it is an investigational or a commercial product. Failure to comply with regulatory requirements for post approval CMC changes can potentially lead to ―misbranded or adulterated‖ status for a given product. This should be taken very seriously for marketed products because of the potential safety/efficacy impact for the vast number of patients as well as legal, regulatory and business impact for the sponsor. This retrospective approach provides a clear path for SUPAC in various parameters such as change in components, composition, batch size of the formulation, manufacturing site, manufacturing equipment, process as per USFDA norms.

Keywords: Chemistry Manufacturing Control, SUPAC – Scale up and post approval changes, USFDA – United States of Food and Drug Administration.