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What is GMP Environmental Monitoring Management and How it Helps the Pharmaceutical Industry? By :Dr. Dhriti Tupe, GxP Expert ® In the pharmaceutical industry, adhering to Good Manufacturing Practices (GMP) is critical to ensuring that drugs are produced in a safe and high-quality manner. One essential component of GMP is Environmental Monitoring Management (EMM), which involves…
Improving your ability to read nutrition research can enhance your understanding of food science and help you make more informed choices. It might seem overwhelming at first, but with a few structured steps, you’ll become more confident in navigating studies and understanding their conclusions. Here’s a detailed guide to get you started. 1. Find a…
Drug-Device Combination Products: Methodologies for User Interface Evaluation The development of drug-device combination products (DDCPs) has become a pivotal aspect of modern healthcare, integrating therapeutic drugs with medical devices to enhance drug delivery, improve patient adherence, and optimize outcomes. As these products play an increasingly significant role in healthcare, ensuring their safe and effective use…
Quality Control vs Quality Assurance vs Total Quality Management: Understanding Their Role and Importance in the Pharmaceutical Industry By :Dr. Dhriti Tupe, GxP Expert ® In the pharmaceutical industry, ensuring the safety, efficacy, and consistency of products is non-negotiable. This responsibility is upheld by three key pillars: Quality Control (QC), Quality Assurance (QA), and Total Quality…
In Vitro Release Test (IVRT) for In Situ Gel/Depot-Forming Drug Products Introduction: In situ gel and depot-forming drug products have become a focus in the pharmaceutical industry for their ability to provide prolonged drug release at the administration site. This characteristic makes them ideal for treatments requiring sustained drug delivery, improving patient compliance and therapeutic…
Detailed Explanation of Teriparatide Generic Approval Process Peptide Drug Characterization: An Essential Step The FDA’s focus on peptide drug characterization involves an intricate process that ensures the generic drug’s chemical and biological profile matches that of the RLD. The characterization process is not just about verifying the peptide’s primary sequence but also examining its higher-order…
ALCOA vs. ALCOA++: Understanding Data Integrity in the Pharmaceutical Industry By :Dr. Dhriti Tupe, GxP Expert ® Data integrity is the backbone of compliance and quality in the pharmaceutical industry, ensuring that all data is accurate, reliable, and secure. Over the years, the concept of ALCOA has served as a guideline for maintaining data integrity. However,…
Explore 5 lucrative intellectual property career paths for science graduates. Discover how to leverage your scientific expertise in patent law, technology transfer, and IP management. Are you a science graduate looking to bridge the gap between innovation and law? The world of intellectual property (IP) offers a fascinating array of career opportunities that blend scientific…
Why Risk Assessment and Mitigation Controls Reporting is Mandatory for QA and How to Handle It? By :Dr. Dhriti Tupe, GxP Expert ® In the pharmaceutical industry, quality assurance (QA) isn’t just about meeting regulatory requirements—it’s about safeguarding patient health and ensuring that every product delivered is safe, effective, and of the highest quality. A critical…
Cluster Development Programme (CDP) & Data Governance: Why It’s Mandatory and How to Handle It in the Pharmaceutical Industry By :Dr. Dhriti Tupe, GxP Expert ® In the rapidly evolving landscape of the pharmaceutical industry, the integration of technology and data has become paramount. Among the many initiatives that have gained traction, the Cluster Development Programme…
