In 2020 a mission was organized and led by the WHO Local Production and Assistance (LPA) Unit, under the Regulation and Prequalification Department (RPQ), with close collaboration from the WHO Country Office for Egypt (CO/EGY) and the WHO Regional Office for the Eastern Mediterranean (EMRO), following the Egyptian Ministry of Health and Population (MOHP) requested for WHO’s technical guidance in reviewing the readiness of a local vaccine manufacturer for COVID-19 vaccine production process and provide technical assistance to the manufacturer for the implementation of COVID-19 vaccine production and prequalification in order to be a manufacturing hub in Africa for COVID-19 vaccines.
During the mission from 27 to 30 of September 2020, the WHO
Local Production (LP) Mission Team assessed the manufacturer’s production
capabilities and readiness for manufacturing COVID-19 vaccines. Gaps in
compliance with WHO and international cGMP standards of the manufacturer’s
production facilities were identified and the findings toward their readiness
for manufacturing COVID-19 vaccines were presented to the Egyptian MOHP and the
manufacturer itself.
Two years later, a mission has been organized and led by the WHO Local Production and Assistance (LPA) Unit,
with close collaboration from the WHO CO/EGY and the WHO/EMRO, from 30 October
to 03 November 2022, to follow-up on the local vaccine manufacturer’s progress
on addressing the gaps in cGMP standards and on the proposed recommendations
from the WHO LP Mission Team in September 2020. During this mission,
capacity building of the manufacturer’s technical staff was also provided to
strengthen their foundational understanding of the regulatory and quality
requirements of a vaccine dossier for WHO prequalification (PQ) or emergency
use listing (EUL), and thereby increase the quality of the submission dossier.
During the week-long mission, the strengths and areas of improvement for the facilities and dossiers were identified through active participation and collaborative technical discussions with the manufacturer’s technical staff. On the last day of the mission, the WHO Representative of Egypt and the WHO LP Mission Team presented the findings to the Minister of Health and Population upon request by MOHP. The mission concluded with the presentation and deep technical discussion of the findings and proposed next steps with the CEO of the local manufacturer and key senior staff, which were accepted to enable follow-up action.
Hands-on capacity building workshop on CTD requirements of a vaccine dossier for WHO PQ/EUL
A visit to a local vaccine manufacturing facility in Egypt by the WHO LP Mission Team led by Dr Jicui Dong, Mission Team Lead & Unit Head LPA/RPQ/MHP
For more information, please contact the Local Production & Assistance Unit (LPA) at: localproduction@who.int