FDA Releases SUPAC Guidance

Apr 02, 2013

FDA has released a draft guidance of scale-up and post-approval changes that combines and supersedes previous guidance documents: SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum and SUPAC-SS Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum. FDA states that the new draft SUPAC addendum should be used in combination with the other SUPAC guidance documents.

This draft guidance, Guidance for Industry SUPAC: Manufacturing Equipment Addendum, Draft Guidance, removes the lists of manufacturing equipment that were in the previous guidance documents and clarifies the types of processes being referenced. It defines levels of chemistry, manufacturing, and control change; recommended chemistry, manufacturing, and controls tests for each level of change; recommended in vitro dissolution and release tests and/or in vivo bioequivalence tests for each level of change; and recommended documentation that should support the change for new drug applications and abbreviated new drug applications.