Managing document requests during an Inspection
It is at the discretion of an inspector to request documents before, during, and after an inspection. A document request after an inspection may call for a surprise even if the closing meeting was uneventful. On-site Vs Remote For obvious reasons, remote inspections are expected to have more document requests before the inspection as compared […]
In the present era, we are witnessing quite a lot of mergers and acquisitions (M&A) in the pharma industry. As a result, the concept of due diligence is gaining a lot of importance. Although there is some similarity between audits and due diligence with regards to the review of the systems, the purpose is different! […]
The Pharmacovigilance System Master File (PSMF) stands as a crucial document in the realm of Good Pharmacovigilance Practice (GVP). It has been a cornerstone of the guidelines put forth by the European Medicines Agency back in 2012. Regular ad-hoc reviews of the PSMF are a common practice, particularly during audits or due diligence processes. It […]
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 […]
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 […]