Zdrowie i gospodarka · 2.12.2014
Guidance for Industry on Scale-Up Post-Approval Changes: Manufacturing Equipment Addendum; Availability
The Food and Drug Administration (FDA) is announcing the availability of a scale-up and post-approval changes (SUPAC) guidance for industry entitled "SUPAC: Manufacturing Equipment Addendum." This replaces the draft guidance of the same name that combined and superseded "SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms: Manufacturing Equipment Addendum," published on January 1, 1999; and "SUPAC-SS: Nonsterile Semisolid Dosage Forms; Manufacturing Equipment Addendum," published as a draft on December 1, 1998. FDA revised the draft manufacturing equipment addenda to remove the equipment examples and to clarify the types of processes being referenced.