SUPAC guidelines

SUPAC guidelines are FDA guidelines for Scale-Up and Post-Approval Changes
for manufacturing of drugs.

  • SUPAC-MR/MR : Immediate Release and Modified Release Solid Oral Dosage Forms(Revision
    1 final) (1999)

  • SUPAC-MR:Modified Release Solid Oral Dosage Forms (1997)

  • SUPAC-SS : Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum(Draft
    1999)

  • SUPAC-SS : Nonsterile Semisolid Dosage Forms (1997)

  • SUPAC-IR/MR : Immediate Release and Modified Release Solid Oral Dosage Forms Chemistry,
    Manufacturing, and Controls (1995)