What is most important for an inspector / auditor?
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 […]
“Some things are inevitable during pharmacovigilance audits and inspections; that doesn’t prevent you from preparing!” In today’s world of information technology (IT) advancement, everyone is talking about artificial intelligence, robotics, automation, and machine learning. It is rather unlikely that things would go wrong during an audit or inspection, more so specifically due to a trivial […]
The pharmacovigilance audit universe consists of 100% of audit targets which will be audited in a span of 2-5 years. This information forms a part of the strategic audit plan that includes the auditing target, risk assessment, frequency and the year when audit will be performed. Audit targets These may include distributors, business partners, affiliates […]
The pharmacovigilance audit universe is not limited to the distributors, business partners, affiliates,and vendors / service providers. One also needs to consider pharmacovigilance processes as well as processes of cross-functional departments which may have a direct or indirect impact on patient safety compliance. These processes are not limited to: Information Technology (including Safety database) 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 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 […]
A robot for handling calls When we think of medical information, the first thing that comes to mind is a call centre representative working in the 9-5 shift and providing information regarding a particular medicine. Imagine if this activity is performed by a robot that is available 24/7/365 and can understand every language and access […]
By safety labels, we refer to the cartons, packaging materials, prescribing information, reference safety information or even the patient information leaflet or consumer information guide, which may contain relevant safety information. The associated safety text gets updated whenever there is any update to the safety profile of the product. The prescribers, pharmacists, nurses, care-givers, or […]
By distributor, we mean the business partners who support the commercialization of the company products in the concerned territories. We won’t discuss the non-compliance areas but provide considerations for the marketing authorization holder (MAH) for ensuring compliance. Every MAH can’t have commercial operations in every country in which it holds licenses. This may even apply […]