inspection

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: Medical Information […]

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 […]

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 PhV, 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 Are all the Pharmacovigilance activities handled in-house? Have you outsourced any of your Pharmacovigilance activities? On what basis was the vendor selected? Qualification process? Audit? Onboarding process? Does the vendor have any BCP measures in place? Can you show the details of this […]

Health Canada (HC) is one of those authorities which has set its expectations with regards to GVP inspections clearly and there is a lot of information available on the HC website to substantiate this. Did you know that HC has a dedicated website for GVP inspections, where one can find information on the Pharma entities […]