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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…

Quality Assurance (QA) has become an integral aspect of pharmacy practice, particularly in drug safety. As the healthcare landscape evolves, pharmacists are increasingly tasked with ensuring that medications are used safely and effectively. This article examines the importance of QA in community pharmacies, outlines best practices for QA implementation, discusses the impact of technological advancements…

My name is Binh Nguyen (2) Binh Nguyen | LinkedIn and I’m a retired FDA officer after 20+ years of working for the US FDA and as a hospital pharmacist.  I am a founder and CEO of Wynngate Consulting.  I’m writing this article to discuss ongoing quality issues with bio/pharmaceuticals and to provide quality solutions…

Indian Pharma Industry Under Scrutiny: Join Eminence Group’s Pledge to Uphold Quality!In the wake of recent revelations, the Indian pharma industry—a cornerstone of global healthcare—finds itself facing a critical juncture. The August 2024 drug alert report from the CDSCO has flagged 53 widely-used medications, including Paracetamol and Pan-D, as "Not of Standard Quality" (NSQ). This…

Rajendra Kumar Kasi, Vice President and Global Head – Pharmacovigilance, Glenmark in conversation with Team Eminence Business MediaPharmacovigilance audits are vital to ensuring that pharmaceutical companies meet regulatory guidelines and, more importantly, protect patient safety. These audits ensure that companies follow rigorous protocols for detecting, assessing, and preventing adverse drug reactions. It was a pleasure…

Guarding Against Nitrate Variability and Water Contamination: New Nitrosamine Guidelines Released In a move that’s shaking up the pharma industry, regulatory bodies worldwide have introduced stricter guidelines on nitrosamine impurities in medicinal products as of September 2024. Nitrosamines, known for their potential to increase cancer risks, can form during drug manufacturing or storage. With these…

Alina PanourgiaPharmacovigilance and Regulatory Compliance AdvisorComposite PharmaIs AI the ultimate answer to drug safety? As pharmacovigilance evolves to keep pace with the pharmaceutical industry, the rise of Artificial Intelligence is transforming how we monitor the safety of medicines. AI offers incredible potential by analysing vast amounts of safety data from health records, patient registries, and…