1.
APQR Management
• Preparation and review of Annual Product Quality Review (APQR) as per defined SOP timelines
• Compilation of data from:
• Batch manufacturing & packing records
• Analytical results
• Deviations, OOS, OOT, CAPA
• Perform trend analysis and identify:
• Process variability
• Quality risks
• Improvement opportunities
• Ensure completeness, accuracy, and consistency of APR data
• Provide recommendations and action points based on review