WHO global benchmarking tool plus rev. VI+ ver. 1 - Regulatory Inspection (RI)

Overview

Inspection of establishments across the medical product supply chain is an essential regulatory function. The supply chain includes manufacturers, distributors, re‐packagers, re‐labelers, importers, agents, traders, wholesalers and retailers of medical products. The purpose of regulatory inspections is to ensure that operations at these establishments are carried out in accordance with approved standards, norms, and guidelines and are in compliance with the national medical products legislation and regulations. These, in turn, should be consistent with World Health Organization recommendations and other internationally recognized guidelines. The scope of the function applies to different Good Practices (GXPs) and is not limited to Good Manufacturing Practices (GMPs). Good Distribution Practices and Good Clinical Practices also come under the scope of this function. Good Vigilance Practices are not addressed in this function but are addressed under the vigilance function.