supac for modified relese dosage form

Malay N. Jivani

SUPAC

Scale - Up and Post Approval

ChangesPrepared by:Malay N. JivaniM.Pharm sem 1 (Ceutics)Sub. APT

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

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)

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

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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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

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

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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