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6 Sep 2021

What is Scale-Up and Post Approval Changes (SUPAC) report?

The scale-up process 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, or SUPAC.

If a contract manufacturing organization (CMO) is not already involved in the pharmaceutical R&D process of the drug it will mostly likely be involved in scale up. With the CMO, the product profile must be defined including the critical quality attributes (CQA). CQA are the biological, microbiological and physical attributes that can be measured and defined for a drug so that quality can be monitored and controlled. When the product profile is defined, the appropriate manufacturing process can be designed. This includes selecting equipment and doing a Scale-Up and Post Approval Changes (SUPAC) report to ensure, for example, that the right equipment has been selected.

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