Article | May 5, 2021

Why Are Feasibility Studies Important For Your Pharmaceutical Product?

By Holger Shen, Technical Services Manager, Bora Pharmaceuticals

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A feasibility study is a trial run that tests your manufacturing steps, materials, and equipment to confirm that your process is designed correctly. During a feasibility study, any differences in the process resulting from the scale, materials, or equipment differences will be exposed. Identified Critical Process Parameters (CPP) may need to be adjusted. The knowledge gained during a feasibility study will help mitigate the risks before submission to regulatory agencies or Process Performance Qualification (PPQ) batches.

Why a Feasibility Study is Important; Is a Feasibility Study Optional?

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