Jaano & Seekho – Know More. Think Deeper. Stay Ahead.
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Extractables and leachables: definitions, differences & facts Extractables and leachables are contaminants that are causing biopharmaceutical manufacturers headaches, as they can lead to impurities of highly valuable drug products. The FDA defines the two terms as follows: Extractables are compounds that can be extracted from the container closure system when in the presence of a solvent Leachables…
Visible Particles in Parenteral Drug Products: A Review of Current Safety Assessment Practice Visible particles (VPs) in parenteral drug products (PDPs) pose significant safety risks to patients and are a critical quality concern in the pharmaceutical industry. Despite technological advancements in particle detection and stringent regulatory controls, contamination with VPs remains a challenge. This review…
Deciding between Direct Vs Regular Mutual Funds is one of the first dilemmas that new investors in India face. With the mutual fund industry having expanded tremendously in the last decade, this decision can have a significant impact on your investment returns over the long run. With lower expense ratios, transparency and flexibility, direct mutual…
In the bustling city of Hyderabad, amidst the chaos of daily life, Akash, a young professional, often found himself pondering the future. Like many of his peers, he was caught up in the whirlwind of career aspirations, personal goals, and the desire to secure a comfortable life for his family. However, beneath the surface of…
Introduction: Clinical trials are essential for evaluating the safety and efficacy of new medical treatments. They provide a rigorous framework for testing hypotheses and drawing reliable conclusions. However, statistics plays a crucial role in ensuring that clinical trial results are accurate, unbiased, and meaningful. In this blog post, we will explore the significance of statistics…
Why DQ, IQ, OQ, PQ Are Mandatory in Quality Assurance: Why It’s Essential and How to Handle It? By :Dr. Dhriti Tupe, GxP Expert ® In the pharmaceutical and life sciences industries, ensuring that equipment, systems, and processes are properly designed, installed, and operated is not just best practice—it’s a regulatory requirement. The key tools used…
Cleaning Validation and Verification Reporting: A Mandatory QA Requirement By :Dr. Dhriti Tupe, GxP Expert ® Introduction In pharmaceutical manufacturing, ensuring the quality and safety of products is paramount. One critical aspect of quality assurance (QA) is cleaning validation and verification, which confirms the effectiveness of cleaning processes in removing residues and contaminants. Why is Cleaning…
ax planning forms an integral component of an individual’s financial management. It involves organising one’s financial affairs to optimise tax liability within the legal framework. This article intends to simplify the meaning, importance, and benefits of tax planning and thus reinforce its relevance in efficient financial management. What is Tax Planning? Tax planning is the process of…
Handling Elemental Impurities Risk Assessments in Pharmaceuticals By :Dr. Dhriti Tupe, GxP Expert ® A Comprehensive Guide Elemental impurities in pharmaceuticals can be harmful to patients. Regulatory agencies have set guidelines to manage these risks through proper assessments. In this blog, we’ll explore the essentials of elemental impurities risk assessments, including key considerations, best practices,…
Do You Invest in Your Health? By Thushara Mohan, Coach ,Fittr Four years ago, I made one of the best decisions of my life — I began investing in the most valuable asset I own: my health. At the time, I was a complete beginner to fitness and nutrition. With the help of a colleague,…
