Eminence Group

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…

A Narrative by AV Jayakumar, President – Corporate Quality Assurance, Ajanta PharmaIn the high-stakes world where every action of Indian pharma companies is closely watched, cross-contamination is a challenge that requires constant vigilance. As someone deeply entrenched in the industry, AV Jayakumar has first-hand experience of how easily contamination can compromise a product's integrity. During…

Impurities have become a significant concern for the industry, particularly following recent discoveries of harmful contaminants in widely used drugs. The presence of Diethylene Glycol (DEG) and Ethylene Glycol (EG) in medicinal products has emerged as a critical issue, leading to global recalls and triggering more stringent regulations by agencies like the U.S. FDA. These…

Jegan IsraelGeneral Manager Quality & ComplianceZydus LifesciencesEvery life science company knows that quality is of the utmost importance. But defining quality and aligning that definition to regulations requires an intentional approach and this is how QMS came into the picture. QMS; Quality Management System, a comprehensive system that a an organization uses to manage quality…

Subhrangshu ChaudhuryVice President & Head of Quality Centaur PharmaceuticalsOver the past few years, the term “Quality Culture” has become quite a buzzword. I recently attended a conference where senior leaders across different industries were discussing this topic. It triggered my thoughts. I am a quality leader who has worked in pharma for almost two decades…

Two decades ago, the Indian pharmaceutical industry faced a seismic shift as data integrity issues emerged, challenging the core operations of the sector. Today, pharma professionals operate in a transformed landscape where stringent data integrity controls are the norm, ensuring compliance and maintaining quality standards.The current pharmaceutical environment places quality above all else, with rigorous…

20 Things Never to Say to an FDA Investigator Inspired by Vincent F Cafiso the Director of Quality and Regulatory Services at CREO and a former FDA Investigator – presented by Vrushali Negandhi I always look forward to the little anecdotes that Vincent Cafiso shares from time to time. Vincent, the Director of Quality and…

In the fast-paced world of pharmaceuticals, precision and compliance are paramount. As technological advancements reshape the industry, computer software assurance (CSA) and validation have become critical components in ensuring quality and regulatory compliance. With the advent of artificial intelligence (AI) and other cutting-edge technologies, the landscape of CSA is evolving rapidly. However, these advancements are…