Scale Up Post Approval Changes (SUPAC) refers to the process of increasing batch sizes during product development and making changes to composition, manufacturing process, equipment, or site after a product has been approved. The FDA has issued guidance for SUPAC changes for immediate release solid oral drugs, modified release solid oral drugs, and non-sterile semisolid products. This guidance defines changes as minor, moderate, or major and outlines requirements for annual reports, supplement filings, or prior approval supplements depending on the level of change. Tests like application tests, dissolution/release tests, and in-vivo tests may be required based on the type and level of change.

1. Scale Up Post Approval Changes
(SUPAC)
In the process of developing the new product, the batch size used in earliest
human studies are small.
 The sizes of the batch is gradually increased(scale up).
The scale up and the changes made after approval in the:- a)
a) composition
b) manufacturing process
c) manufacturing equipment and
d) change of site
have become known as scale-up and post approval changes (SUPAC)

2. FDA has issued various guidance for SUPAC changes, and
designated as:-
1. SUPAC-IR (immediate release solid oral dosage form .
2. SUPAC-MR (for modified release solid oral dosage form)
3. SUPAC-SS (for non sterile semisolid dosage form including
creams, ointments, gels and lotions).

3. SUPAC GUIDELINE DEFINES
According to the changes to be made these are as :
LEVEL OF CHANGES
 Minor changes
 Moderate changes
 Major changes
FILLING
 Annual report
 Changes being affected supplement filing
 Prior approval supplement
TESTS :
 Application/compendial tests
 In-vitro dissolution/release
 tests In-vivo