Zdrowie i gospodarka · 02/12/2014

FDA Releases Revised Guidance for Scale-Up Post-Approval Changes in Manufacturing Equipment

The Food and Drug Administration (FDA) has made the revised SUPAC: Manufacturing Equipment Addendum guidance document available, which replaces previous drafts and supersedes earlier versions, including 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, published on January 1, 1999, and December 1, 1998, respectively.