Product Quality Review (PQR)* Determine the need to make changes to manufacturing processes, process controls, in-process tests or product specifications + Verify compliance with marketing authorisations : Verify the consistency of manufacturing processes * Determine the need for re-validation of existing processes : |dentify product or process improvements : Identify any adverse trends and the need to take corrective and preventive action * Determine the appropriateness of starting material and product specifications.Product Quality Review is regular periodic or rolling quality reviews of all licensed medicinal products, including export only products, which are conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product to highlight any trends and to identify product and process improvements. The Product Quality review (POR) is an effective quality improvement tool to enhance the consistency of the process and the overall quality of the product. The POR will capture a broader view of product data, capturing trends and will help determine the need for revalidation and changes, if any.* What is the Product Quality Review? * Objectives * EU GMP requirements * PQR Relationship to the Quality System * Six Areas: Product Specific Reviews * Six Areas: Modular Reviews * Follow Up Actions(v) Areview of all changes carried out to the processes or analytical methods. (vi) A review of Marketing Authorisation variations submitted, granted or refused, including those for third country (export only) dossiers. (vii) A review of the results of the stability monitoring programme and any adverse trends. (viii) A review of all quality-related retums, complaints and recalls and the investigations performed at the time. (ix) A review of adequacy of any other previous product process or equipment corrective actions.| (x) For new marketing authorisations and variations to marketing _ authorisations, a review of post-marketing commitments. | (xi) The qualification status of relevant equipment and utilities, e.g. HVAC, water, compressed gases, etc. (xii) A review of any contractual arrangements as defined in Chapter 7 to ensure that they are up to date.PQR Relationship to the Quality System CAPA and Improvement Compliance to Validation Marketing ® Re- Authorisation (®) walidat @) ion PQR)« end vmP @) Product Risk Management Specifications and ControlsvVvv Vv Marketing Authorisation and Post Marketing Commitments Regulatory Agency Inspections (product related observations and commitments) Regulatory Agency Product Notices Recalls / Marketplace Alerts / Adverse Events Regulatory Affairs and QA41.Legal: MarketAuthorisation & Regulatory Notices 2.External: Complaints, Recall Adverse Events & Recall 3.Processes: Controls, Changes & Process Validation 4.Product: Product Testing, OOS, Failures, Retention Samples and Stability 5.Quallty Control: Product Specification, Test Methods and Changes 6.Events: Product Related CAPAs & Incidents/deviations=VVVV Customer complaints Product recall Adverse event profiles Product returns Medical Affairs and QABatch Record Review including in-process controls Rework/Reprocessing/ Rejects Yield, Deviations and Product Investigations Process Validation Review Product / Process related changes Production and QA/ValidationQuality Control Testing Review results — include OOS events and non- conformances) Finished Product Specification Review Test Method Validations and Laboratory Changes Stability Programs Retention Samples Vv "Vv vv mo QC and QA> Effectiveness of corrective actions — close outs » — Follow up from previous APR reports > — Significant product related deviations and incidents » Internal audits (product related observations) Production and QAFollow-up actions may be included but are not limited to: > Product process improvement » Formulation improvement » Analytical method improvements * In-process or final product specification review » Revalidation » Product recall or withdrawal » Change of RM/PM