Breif of Scale up technology in pharmaceuticals

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