Product Quality Review

As a pharmaceutical manufacturer, you’re likely already aware that Product Quality Review (PQR/APQR) isn’t optional—it’s mandated by global regulations like 21 CFR Part 211.180(e), EU GMP Chapter 1, and WHO TRS 986. The goal? To ensure consistent product quality, uncover trends or deviations, and verify the effectiveness of your processes. 

But here’s the real challenge: when you’re managing hundreds of products across regions, traditional methods become a bottleneck. Manual data pulling from ERP, LIMS, eBMR, EQMS, and charting in Excel can take 2–6 weeks per product—not to mention the high risk of errors. 

That’s where our PQR solution in QEdge comes in.