inspections

Many Pharmacovigilance and Quality personnel have approached me in the last few years, requesting a Pharmacovigilance Audit Checklist. I also used to be happy to share the version I had prepared in 2012 for my first audit assignment in the European Union. Some of the requestors reverted, stating that the checklist served the purpose, and […]

Ghana joined the WHO International Drug Monitoring Program in November 2001 as the 65th member of the program and the first country from West Africa to get enrolled. Ever since the Pharmacovigilance guidelines have well evolved. These guidelines are even updated from time to time. The MAH is required to report domestic serious reports within […]

“The best way to survive an FDA inspection is to be prepared for it!” An FDA Pharmacovigilance inspection is generally unannounced. However, if it pertains to a foreign/ Non-US site, it is likely to be a pre-announced one. What are the types of FDA Pharmacovigilance inspections? 1. Post Marketing Adverse Drug Experience (PADE) 2. Risk […]