This document offers guidelines to ensure the quality and safety of medical products throughout the supply chain. It underscores the significance of proper storage and distribution in managing medical products, highlighting the potential risks posed by substandard and falsified items. The guideline advocates for a robust collaboration amongst all entities in the supply chain, from manufacturers to distributors. A primary emphasis is placed on the establishment of a comprehensive quality system that integrates Good Storage Practices (GSP), Good Distribution Practices (GDP), and quality risk management. This system should be adept at assessing, controlling, communicating, and reviewing risks at every stage of the supply chain. Periodic management reviews are recommended to gauge the effectiveness of the quality system and pinpoint areas for improvement. Additionally, the document outlines procedures for handling complaints about product quality or packaging, ensuring that any concerns are addressed promptly and effectively. This guideline serves as an essential resource for all stakeholders involved in the storage and distribution of medical products.
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ISO 9001:2015 - FS766975
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