Assessment and Trend Analysis of Good Manufacturing Practices Inspection Findings of the Ethiopian Food and Drug Authority
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Date
2026-01-26
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Addis Ababa University
Abstract
Introduction: The spread of poor-quality medicines, especially in developing countries, has
been a global public health concern. Among the reported Substandard and Falsified medicines to
the WHO Global alert system, 50% are from Sub-Saharan Africa, and 80% of these are for
essential medicines. Adherence to GMP is a key requirement for ensuring that pharmaceutical
products are manufactured and controlled to meet the quality standards set out by the regulatory
authorities. This study assessed the GMP inspection reports of the Ethiopian Food and Drug
Authority (EFDA) for both local and foreign medicine manufacturing facilities, conducted
between 2015 and 2024, and the first 3 months of 2025, and compared the findings with reports
from other regulatory authorities.
Objective: The aim of this thesis was to evaluate the GMP inspection findings of the EFDA over
ten years period (2015 to 2024 and the first 3 months of 2025).
Method: A retrospective quantitative study design was used to evaluate the GMP inspection
findings of the authority. GMP inspection reports from 2015 to 2024 and the first 3 months of
2025 were reviewed. Data was collected from December 2024 to January 2025 and March 2025
at the EFDA head office, Addis Ababa, Ethiopia. A total of 518 reports were reviewed.
Results: During 2016 – 2018, local inspections, 380 deficiencies were identified from the review
of 7 GMP reports. The most common deficiencies were related to quality management,
materials, production, quality control, materials management and water for pharmaceuticals.
Only one facility was found acceptable. During 2019 to the first 3 months of 2025, local
inspection, 33 reports were reviewed from the available 12 local facilities. Half (6) of the
facilities were GMP compliant. A total of 288 deficiencies were recorded during this period, of
which 17.7% were critical findings. The most common deficiencies were related to quality
management, validation and qualification, premises, good practice in QC and HVAC. An
additional 478 international inspections were conducted between 2015 & 2024 across 31
countries. The most common deficiencies were related to good practice in QC, material
management, HVAC, production, and premises.
Conclusion: The finding of this study indicates that a significant number of both local and
foreign pharmaceutical manufacturing facilities are not operating in adherence to GMP
standards. Therefore, robust regulatory oversight and continuous improvement from facilities are
required to ensure the safety and quality of medicines. Regular assessment, trending, and public
disclosure of common deficiencies will contribute to the improvement of GMP compliance of
facilities and ensuring the availability of safe and quality pharmaceutical products in the market.
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Keywords
Quality, good manufacturing practice, Ethiopia, inspection, compliance, deficiencies. ix