Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
in a pharmaceutical industry
Presented by
Vaidehi daruvuri
Reg no:y18mph0284
Dept of pharmaceutical regulatory affairs
Under the guidance of
G.Ramakrishna .,M.Pharm
Dept. of Pharmaceutics
What is supac?
• In the process of developing a new product , the batch
size used in earliest human studies are small.
• The size of the batch is gradually increased ( scale up).
• The scale up and the changes made after approval in the
composition manufacturing process , manufacturing
equipment and change of site have become known as
scale up and post approval changes (supac).
New Drug Application
SCALE-UP
(NDA) approved by FDA Larger Batch size
Bioequivalent to
the FDA reference
Generic Drug Product
listed drug
(RLD)product
ANDA or AADA
Larger Batch size SCALE UP approved by FDA
Scientific Rationale
of drug products
• In component or composition
• Changes affecting:
- Equipments
- Manufacturing process