Why DSMB Audits Matter: A Quality Assurance Perspective
Testing new treatments on patients with life threatening diseases requires immediate understanding of whether the treatment helps or harms. Data Safety Monitoring Boards (DSMB) provide this critical oversight. Proper auditing of these boards ensures trial integrity and patient safety. The Stakes The Challenge A DSMB requires clear rules documented in a DSMB Charter. This defines […]
The Audit Question That No One Wants to Answer In my years conducting audits, I often paused at the Business Continuity Plan (BCP) section and asked a simple, uncomfortable question: “If the internet stops working completely for 48 hours, how will you submit your expedited safety reports to the regulatory authorities?” The answers were often […]
In the world of Pharmacovigilance, we often fixate on the technical: regulatory requirements, SOPs, and data integrity. While technical expertise is non-negotiable, it is only half the battle. To truly drive improvement and ensure patient safety, an auditor must master the human element. Soft skills are not just “nice to have”; they are essential competencies […]
The other day someone asked me “What does it take to become a PV Auditor? Can I become one?”. I spontaneously responded that you should know the regulations, processes as well as some experience in the quality management system. Then came the tricky question, “How can I become a good PV Auditor?”. I knew this […]
What do you think is the single most important factor for an inspector or auditor? Believe it or not, it is ‘time’. The auditor is already hard-pressed for time and needs to find as many gaps as possible in the stipulated timeframe allocated for the audit. You cannot afford to take any chance, irrespective of […]
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 current era, the pharmaceutical industry is witnessing a surge in Mergers and Acquisitions (M&A). As a result, the concept of due diligence has gained significant importance. While there are similarities between audits and due diligence—specifically regarding the review of systems—their fundamental purposes are distinct. Understanding these differences is crucial for Pharmacovigilance professionals navigating […]
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 […]