Blogs

As someone who has spent many years working across different regions and regulatory environments, I can say that the pharmacovigilance (PV) landscape in the Rest of the World (RoW) is quite complex and diverse. Unlike the US or Europe, where regulations are well-established and enforcement is consistent, many countries in the RoW are still developing…

In the rapidly evolving field of pharmacovigilance, maintaining a robust Quality Management System (QMS) is critical, not only for ensuring regulatory compliance and safeguarding patient safety, but also for driving continuous improvement. With over two decades of experience in drug safety and clinical research, I’ve learned that the success of a QMS is not solely…

#EminenceDigitalDetox: Breaking ‘I would rather check my phone than face my problems’ attitude.Studies show that individuals check their phones over 100 times a day, leading to feelings of anxiety, distraction, and disconnection from the present moment. This year, in response to these growing concerns, we ran an experiment at our work place, after witnessing a…

Many developments in silica particles used in liquid chromatography (LC) have been well documented over the years. The move from irregular silica to spherical silica, the decrease in particle size from >5µm particle in high performance liquid chromatography (HPLC) to sub-2-µm particle size in ultrahigh-pressure LC (UHPLC), the improved silica purity of type B silica…

BackgroundIn 2002, US-FDA launched an initiative, ‘‘Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach,’’ to enhance and modernize the regulation of pharmaceutical manufacturing and product quality.1 One objective, among others, was to facilitate the implementation of a modern, Risk-based Pharmaceutical Quality Assessment system. The desired state has been described as a maximally efficient, agile, flexible…

Dubai: A Gateway to Growth, Innovation, and Pharmaceutical ExcellenceBy Vrushali NegandhiJust a couple of years ago, I found myself standing in the middle of Dubai’s vibrant skyline, overwhelmed by the city’s sheer dynamism. What struck me most wasn’t just the towering skyscrapers or the bustling trade zones—it was the precision, ambition, and seamlessness with which…

At its foundation, GMP (Good Manufacturing Practices) is a robust manufacturing framework engineered to uphold consistent product quality and integrity. Encompassing a breadth of critical elements - from meticulous hygiene and sanitation protocols to comprehensive quality management systems - GMP aims to mitigate and, ideally, eliminate substantial risks to quality like cross-contamination, mislabelling, and process…

Disclaimer:  The views & Opinions expressed in this article by an Author is not necessarily reflect the official policy or position of the company where author is associated with currently."It's fine to celebrate success but it is more important to heed the lessons of failure." – Bill GatesIntroduction: Success & failures are part of journey…

“Change in inevitable, and the disruption it causes often brings both inconvenience and opportunity”Robert ScobleDisruption as defined by Cambridge dictionary is an interruption in the usual way that a system, process, or event works.The pharmaceutical industry is undergoing significant disruption due to rapid technological advancements, evolving market demands, and changes in regulatory environments. These disruptions present challenges, but they also offer opportunities for…

Disclaimer: The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of Novartis or any of its officers.Introduction: Project managers in the Indian pharmaceutical industry deal with different kinds of projects that involve ensuring compliance with regulatory & quality standards; managing multiple…