Definition Need for SUPAC Guideline SUPAC Guidelines for MR Levels of Change Manufacturing change : Process & Equipment Limitations of SUPAC

1. Scale - Up and Post
Approval Changes
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2. Content
 Definition
 Need for SUPAC Guideline
 SUPAC Guidelines for MR
 Levels of Change
 Components and composition
 Manufacturing Site Changes
 Batch size change (Scale up)
 Manufacturing change : Process & Equipment
 Limitations of SUPAC
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3. What is SUPAC
 In the process of developing the new product, the
batch size used in earliest human
 The sizes of the batch is gradually studies are
small.
 The scale up and the changes made after
increased(scale up), approval in the composition
manufacturing process , manufacturing
equipment and change of site have become known
as scale up and post approval changes (supac)
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4.  The SUPAC guidances define:
1. levels of chemistry, manufacturing, and control
change;
2. recommended chemistry, manufacturing, and
controls tests for each level of change;
3. recommended in vitro dissolution and release tests
and/or in vivo bioequivalence tests for each level of
change; and
4. recommended documentation that should support
the change for new drug applications and
abbreviated new drug applications
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5. Level of
Changes
Filing
Tests
•Minor Change
•Moderate Change
•Majour Change
•Annual Report
•Changes Being Affected Supplements
•Prior Approval Supplements
•Application / compendial tests
•In vitro dissolution / release
•In vivo dissolution / release
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6. Need for SUPAC Guidline
 To expedite the processes of post approval changes of
drug products
 FDA can assure their safety and effectiveness.
 Lower the regulatory burden for industry
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7. New Drug
Application (NDA)
Approved by FDA
Generic Drug
Product
ANDA or AADA
approved by FDA
Bioequivalent to the
FDA reference listed
drug (RLD)product
Larger
Batch Size
Larger
Batch Size
Scale up
Scale up
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8.  The FDA has issued various guidance for supac
changes designated as
 Supac-IR (for immediate release solid oral dosage form)
 Supac-MR (for modified release solid oral dosage form)
 Supac-SS (for non sterile semisolid dosage form
including creams, ointments, gels and lotions)
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