audit

Although remote audits and inspections have become a norm after the onset of the COVID-19 pandemic, the limitations of remote auditing remain! There is no doubt that remote audits cannot take precedence over on-site or face-to-face audits. Hence, a middle path is needed, primarily when the whole industry evaluates using Artificial Intelligence (AI), Machine Learning […]

The Pharmacovigilance Audit of a business partner can be tricky, as there may be direct or indirect commercial implications associated with the audit’s outcome. A business partner can be a distributor, wholesaler, or service provider. For the scope of this article, we will primarily focus on product distributors. There can be multiple business partners in […]

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 […]

The Pharmacovigilance (PHV) department is the heart of drug safety, but its health depends entirely on the arteries and veins that feed it—the allied functions across your organization. When a regulatory agency (like the MHRA, FDA, or the EMA) arrives for an inspection, they aren’t just looking at your PHV team’s SOPs and case processing […]

In the last few years, after having audited numerous service providers/ business or licensing partners/ distributors etc., I realized having developed fascination towards this off-shoot of Pharmacovigilance, that is #PhVQA. Thanks to the GVP modules as well as PSMF pre-requisites, coupled with the requirements for MAH to maintain a 2-5 yearly audit schedule, making it […]

Common questions asked by the Pharmacovigilance Inspector, with regards to Pharmacovigilance vendors

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 […]