FDA Updates Scale-Up and Post-Approval Change Guidance

The FDA has finalized the first of four guidances that govern how drugmakers scale up production of a drug once it’s approved, the first revision to the guidances since the late 1990s.

The final guidance encourages drugmakers to use a risked-based approach in evaluating equipment changes during the scale-up and post-approval change (SUPAC) process. It also eliminates references to specific brands of equipment used in prior guidance and replaces them with general equipment categories.

The agency feared industry was limiting its choices for manufacturing equipment to the brands identified in the guidance and stifling innovations in manufacturing.

The new guidance, which made only minor changes to a 2013 draft, defines and classifies risk factors around manufacturing equipment for the production of immediate release and modified release solid oral dosage forms and nonsterile semisolid dosage forms, replacing SUPAC guidance released in 1998 and 1999.

Still to come are revisions to three additional SUPAC guidances also issued in the late 1990s that address testing and filing requirements for these dosage forms.

Together, the four guidances outline the chemistry, manufacturing and control testing, in vitro dissolution and release tests needed to determine if a change in manufacturing planned during scale up is significant enough to require a notification to the FDA. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.