audit

A pharmaceutical company is any commercial entity that may be associated with research, manufacturing, commercialization or distribution of medicinal products. This entity may or may not own the product license, and this factor may decide if this entity will or will not fall under the purview of pharmacovigilance regulations. That doesn’t prevent the company personnel […]

Working in the pharmacovigilance department can be a ‘happening one’ or even a roller-coaster ride. This is irrespective of whether you work for a pharmaceutical company, service provider, monitoring centre, or regulatory agency. Dealing with the rigmarole is going to be a rewarding experience and a satisfying one as you ultimately contribute to the welfare […]

The Pharmacovigilance function is required to have a robust Quality Management System (QMS) and for this, one needs to have efficient standard operating procedures or SOPs. Apart from the SOPs, one can consider other documents, such as working practices (work instructions) or guidelines/guidance documents, as recommended in the QMS of the organization. The list of […]

It was July 2012 when the European Medicines Agency made it mandatory for all the marketing authorization holders (MAH) to maintain the Pharmacovigilance System Master File (PSMF) as per the GVP Module II. Until then, the document was a concise one and called as the detailed description of Pharmacovigilance system (DDPS). After the PSMF came […]

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 […]

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