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Guidance on SUPAC Manufacturing Equipment

12/02/2014

Federal Register Notice: FDA is making available a guidance: SUPAC: Manufacturing Equipment Addendum. It replaces the draft guidance of the same name that combined and superseded SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms: Manufacturing Equipment Addendum on 1/1/99 and “SUPAC-SS: Nonsterile Semisolid Dosage Forms; Manufacturing Equipment Addendum,'' published as a draft on 12/1/98. FDA revised the draft manufacturing equipment addenda to remove the equipment examples and to clarify the types of processes being referenced. To download this guidance, click here. To view this notice, click here.

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