Business Partner Audits in Pharmacovigilance

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 even a service provider. For the scope of this article, we will primarily focus on product distributors. There can be more than […]

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 […]

In the past, Inspections/ audits were synonymous with ‘travel’- both domestic and International, but it is not the norm these days. In 2020, when the Covid-19 crisis plagued the Pharmaceutical industry, many companies had to compromise on their annual audit plans and schedules. With the BCP measures in place, many companies were able to realize […]