10/07/2026
Most companies complete APQR because regulations require it.
The best companies use APQR to improve every batch.
An Annual Product Quality Review (APQR), also known as a Product Quality Review (PQR), is more than a compliance document. It is a strategic tool for identifying trends, evaluating process performance, reviewing CAPA effectiveness, and driving continuous improvement.
A well-executed APQR helps you:
✔ Detect recurring quality issues before they become major risks.
✔ Verify process consistency and product performance.
✔ Evaluate deviations, OOS, complaints, recalls, and stability trends.
✔ Strengthen regulatory compliance and inspection readiness.
✔ Make informed, data-driven quality decisions.
Remember, during an inspection, auditors are interested in more than whether an APQR exists.
They want to know:
“What decisions came out of it?”
Is your APQR simply documenting the past, or is it improving the future?