For the past two decades, the pharmaceutical industry has witnessed a paradigm shift in its approach to process validation; this has been driven by evolving regulatory expectations, technological advances, an increasing emphasis on quality by design (QbD) and continuous manufacturing (CM).
In this article, Dileep Boinipally, Director of Drug Product Formulation at Metsera, starts out with a technical overview of process validation for solid dosage forms and then considers the direction in which the industry is headed.
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