Quality deviation management in Supply Chain

This activity introduces the key concepts of quality deviation management, presenting the different categories of deviations (critical, major, minor) and the risks associated with each stage of the supply chain, from goods receipt to shipment. It also highlights the role of risk assessment in ensuring the safety and effectiveness of pharmaceutical products.

This activity focuses on managing deviations specific to the storage of bioproducts. Learners will learn to handle non-compliant temperature excursions at product reception, monitor and record Time Out of Refrigeration (TOR) during repackaging, and apply strict procedures to prevent deviations during dispatch. The emphasis is on maintaining optimal storage conditions to preserve product integrity.

This activity puts acquired knowledge into practice by analyzing a real-world case of a temperature excursion during the transport of bioproducts. It involves recording and analyzing temperature data, assessing the impact of deviations on product quality, and conducting a thorough investigation to identify and document root causes. This practical case helps build familiarity with deviation management procedures and the implementation of corrective and preventive actions (CAPA).