Regulatory Guidance on Defining Expiration and Shelf Life in Pharma
Accurate assignment and communication of shelf life and expiry date are fundamental to pharmaceutical product quality, safety, and compliance. These two terms—while closely related—are treated distinctly by regulatory authorities such as USFDA, EMA, CDSCO, and WHO. This article provides a detailed look at how these agencies define and regulate shelf life and expiry, helping pharmaceutical…
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