SUPAC Guidelines (Scale Up Post Approval Changes) Scale up : It is the process of increasing something size, amount or production from small scale (less amount) production to large scale (large amount) production. It is the process of increasing batch size and out volume of production. SUPAC: It is the scale up post approval changes (changes made after approval) like formulation of drug, size, site of manufacturing, equipment etc. FDA and American association of pharmaceuticals scientist (AAPS) provided the scientific foundation for the scale-up and post approval changes required for immediate release of product called SUPAC. SUPAC guidelines are extremely important in the pharmaceutical industry as drug maintain quality. After a drug has been approved numerous changes may be applied by the company which could be potentially consistency and quality of the drug. SUPAC guidelines refers: 1. Level of changes Minor changes Moderate changes Major changes 2. Test documentation Applicati
