Documenting Retest vs Expiry Terms for Bulk APIs in Pharma
In pharmaceutical manufacturing, accurately documenting the shelf life of active pharmaceutical ingredients (APIs) is crucial. However, confusion often arises between the terms retest date and expiry date—particularly for bulk APIs. Misuse or misinterpretation of these terms can lead to compliance issues, rejected dossiers, or product recalls. This tutorial clarifies the regulatory expectations and GMP practices…
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