The Egyptian Drug Authority (EDA) organized a specialized training program titled "Training for EDA GMP Inspectors", as part of its commitment to enhancing the efficiency and capabilities of its inspectors in the field of Good Manufacturing Practices (GMP), and improving their technical and regulatory skills in line with the latest international standards, in collaboration with international experts from the European Directorate for the Quality of Medicines & HealthCare (EDQM).

The program aims to develop inspectors’ skills in conducting inspections of Active Pharmaceutical Ingredient (API) manufacturing facilities in accordance with GMP requirements, ensuring the quality and safety of pharmaceutical products and compliance with regulatory standards throughout all stages of manufacturing. It also contributes to strengthening inspectors’ capabilities in technical review, risk assessment, and making relevant regulatory decisions.

The program targeted inspectors of the Central Administration for Pharmaceutical Inspection and was delivered by specialized experts from the Certification of Suitability (CEP) Department at EDQM, through in-person training sessions covering the latest international practices in inspecting API manufacturing sites.

The program included a number of technical and regulatory modules, most notably: inspection activities at the Egyptian Drug Authority, the European inspection program for API manufacturers, risk assessment methodologies, on-site and remote inspections, as well as mechanisms for handling non-compliance cases and taking appropriate regulatory actions.

The training also covered specialized topics related to API manufacturing processes, equipment and facility systems, quality control, data integrity, quality management systems, and change and risk management. In addition, it addressed non-technical aspects of international inspections, such as communication skills and managing various situations during inspection activities.

This initiative comes as part of the ongoing efforts of the Egyptian Drug Authority to support the pharmaceutical inspection and regulatory system, enhance the efficiency of technical cadres, and contribute to improving the quality of pharmaceutical products and raw materials, while reinforcing the Authority’s position in line with the highest international regulatory standards and practices.