Essential medicines and health products

Hands-on learning or refreshing with WHO

Jacqui Rodgers
Jacqui Rodgers

From April to early August last year I was attached to the Regulatory System Strengthening team at WHO as a rotational fellow. As part of this experience, I had the opportunity to participate in a WHO inspection of a vaccine manufacturing facility in South Korea with two of WHO's experienced inspectors, Mustapha and Vimal.

My initial interest at the time was to better understand issues related to Good Manufacturing Practices (GMP) for products I work with as a quality, preclinical and clinical assessor at my agency, the Food and Drug Authority in Ghana. I had participated in GMP inspections before but several years ago and I knew I was out of touch with recent developments, particularly for vaccines.

Both Mustapha and Vimal went out of their way to teach me as much as they could squeeze into the few days we had for the inspection and the prior interaction with the manufacturers. Little did I realize then that this experience would be critical to the success of a major task at my agency.

Recently, I was asked to lead a GMP inspection of an antivenom site. By applying everything I learnt from Mustapha and Vimal, I not only earned the sincere admiration of my team, but also got very good feedback regarding the quality of our inspection report.

What I learnt- and shared with colleagues

Professional yet cordial interaction with the client, planning details, how to steer the opening meeting, risk-based analyses to decide on focus areas for the inspection, time management, incorporation of daily team meetings, application of decorum during the entire exercise, especially in delivering summary findings to the manufacturer, and professionalism when closing the meeting. These were all skills and details that I came to master and appreciate more during the experience.

I wanted WHO to know just how profound the impact of participating in that one inspection has been for me. I have no doubt that my agency will call on me to serve in that same capacity again, and I have every confidence that I will do a good job of it.

Thanks!