Guideline for remote GMP inspection

Abstract

The Ethiopian Food and Drug Authority (EFDA) is a national regulatory body established by the Proclamation No 1263/2021, and its mandatesare defined in the Regulation No 531/2023. One of its key responsibilities is to ensure the safety, efficacy and quality of medicines by regulating the manufacturing of pharmaceutical products forcompliance with Good Manufacturing Practices (GMP) requirements. Globally, various methods are employed to conduct GMP inspection. Remote inspection is one of the inspection processes to enable GMP inspections to continue during the pandemic, resource constraints and others where it has been difficult to conduct these on-site.