Include Annual Product Review (APR/PQR) Linkage for Stability Programs
Understanding the Tip: Why stability data must be part of APR/PQR processes: The Annual Product Review (APR) or Product Quality Review (PQR) consolidates all critical quality data over a 12-month period, including manufacturing, deviations, complaints, and stability performance. Including stability summaries ensures that any emerging trends in degradation, appearance, impurity levels, or batch consistency are…
Read More “Include Annual Product Review (APR/PQR) Linkage for Stability Programs” »