Abstract

RECENT OVERVIEW ON SCALE-UP AND POST APPROVAL CHANGES (SUPAC) AND ANDA SUBMISSION (CBE0, CBE30 & PAS)

Sagar Kishor Savale*

ABSTRACT

SUPAC– Scale up and post approval changes is USFDA associated regulatory guidelines used for scale up of pharmaceutical products as per market requirements. During manufacturing of validated or commercial products any changes will arises for improving their quality and efficiency that changes is done by using SUPAC guidelines. Any changes will arises in FDA approved EB product that changes is done by CBE0, CBE30 and PAS ANDA submission. This articles give information to SUPAC guidelines (Change in excipients, equipment, batch size, manufacturing sites & manufacturing process) and ANDA submission process of FDA approved products (CBE0, CBE30 & PAS).

Keywords: SUPAC, FDA, ANDA, Scale up, Validation & Commercial, Batch size, manufacturing process.