SUPAC (Scale-Up and Post-Approval Changes) is a set of guidelines issued by the U.S. Food and Drug Administration (FDA) to regulate changes in the manufacturing process of pharmaceutical products after their initial approval.
Key Aspects of SUPAC
Purpose: Ensures that post-approval changes (scale-up, site changes, component changes) do not affect the safety, efficacy, or quality of the drug.
Categories of Changes:
- SUPAC-IR (Immediate Release)
- SUPAC-MR (Modified Release)
- SUPAC-SS (Non-Sterile Semisolid Dosage Forms)
- SUPAC-SS for Liquids/Semisolid Topical Dosage Forms
Types of Changes Covered:
- Component & Composition Changes
- Manufacturing Site Changes
- Scale-Up/Scale-Down of Batch Size
- Equipment Changes
Regulatory Impact
- Changes are classified as Minor, Moderate, or Major based on their impact on drug performance.
- Minor changes require annual reporting, while moderate and major changes may need supplemental filings (e.g., Prior Approval Supplement – PAS, Changes Being Effected – CBE).
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