PRODUCT QUALITY REVIEW (PQR) The product quality review is an effective quality improvement tool to improve the consistency of the process and the overall quality of the product. The Product quality review will capture a broader view of product data, capturing trends and will help determine the need for re-validation and changes, if any. All the major regulatory authorities define the requirement of product quality review for example: • European Union (Eudralex): – The additional text “Product Quality Review” for Chapter 1 to the EU GMP Guide has been adopted by the Ad hoc GMP inspectors Working group at their first meeting in July 2003. The proposal of Product Quality Review arises from the experience of Member States’ inspectorates where quality problems with products on the market leading to recall could have been anticipated if the manufacturer/marketing authorization holder ...