quality

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 […]

Apart from Pharmacovigilance department, there are various allied departments that get reviewed during the inspection. The success of the Pharmacovigilance inspection is largely dependent on how the cross-functional stakeholders have fared. That would also mean that the Pharmacovigilance department needs to ensure that these stakeholders perform their work properly. Pharmacovigilance Department (Primary) Secondary: How about […]

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