Regulatory inspection

WHO recommends that, before a medical product is marketed in any jurisdiction, the responsible government ensures that the product meets acceptable standards for safety, efficacy and quality, including compliance with good manufacturing practices (GMP), good clinical practices (GCP), good laboratory practices (GLP) and good storage and distribution practices (GSDP). Inspections of establishments across the medical product supply chain are an essential regulatory function.

The supply chain includes manufacturers, distributors, re-packagers, re-labelers, importers, agents, traders, wholesalers and retailers of medical products (referred to as economic operators in the case of medical devices). The purpose of inspections is to ensure that operations at these establishments comply with approved standards, norms, guidelines and national medical products legislation and regulations.

E-learning courses

All health product types

  • WHO African Vaccine Regulatory Forum GCP inspection

Cross-cutting topics

Instructor-led courses

On-the-job training