Supac For Modified Relese Dosage Form
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Malay N. Jivani
SUPAC
Scale - Up and Post Approval
ChangesPrepared by:Malay N. JivaniM.Pharm sem 1 (Ceutics)Sub. APT
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Malay N. Jivani
Content DefinitionNeed for SUPAC GuidelineSUPAC Guidelines for MRLevels of ChangeComponents and compositionManufacturing Site ChangesBatch size change (Scale up)Manufacturing change : Process & EquipmentLimitations of SUPAC
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Malay N. Jivani
What is SUPACIn 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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Malay N. Jivani
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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Malay N. Jivani
Level of Change
s
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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Malay N. Jivani
Need for SUPAC GuidlineTo 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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Malay N. Jivani
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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Malay N. Jivani
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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Malay N. Jivani
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