Tag: requalification of intermediates

Step-by-Step Guide to Setting Re-Test Periods for Intermediates

Pharmaceutical intermediates—key process materials between starting materials and the final API—are essential to product quality. Unlike finished products, intermediates are typically assigned a re-test period instead of a fixed expiry date. This allows extended usability, provided the material passes re-evaluation. However, setting a scientifically justified re-test period requires a robust approach grounded in ICH Q7…

Re-Test Period vs. Shelf Life in Pharmaceuticals, Shelf Life and Expiry

How to Establish Re-Test Dates for APIs and Intermediates

Active Pharmaceutical Ingredients (APIs) and intermediates form the foundation of pharmaceutical products. To ensure they remain fit for use over time, manufacturers assign a re-test date—a critical component of pharmaceutical quality systems. Unlike shelf life, the re-test period allows continued use beyond the initial assignment, provided the material passes re-evaluation. In this guide, we outline…

Re-Test Period vs. Shelf Life in Pharmaceuticals, Shelf Life and Expiry