Scale-up and Post Approval Changes – SUPAC
If Scale-up and Post Approval Changes (SUPAC) becomes necessary, we will develop with our clients cost-efficient strategies to ensure the acceptability of scale-up and post-approval changes, and long-term stability commitment on post-change batches for new drug applications (NDAs) and abbreviated new drug applications (ANDAs), per 21 CFR 314.70 Supplements and other changes to an approved application.
To facilitate process optimization and SUPAC needs, we will conduct a comparative study on the various types of supplemental amendments regarding SUPAC modifiers including: SUPAC-Immediate Release solid dosage forms (SUPAC-IR) and SUPAC Modified Release oral dosage forms (SUPAC-MR). Once this study is completed, we will develop strategies for changes that need an approved supplement, but may be submitted as changes being effected, or in the next annual report under the SUPAC terms. We will validate the changes, and with our expert regulatory personnel, will provide a mechanism to obtain substantial regulatory acceptance of the post approval changes.