Pharma Knowledge

The detailed procedure for filing New Drug Applications (NDA) in key global markets, including the FDA, EMA, PMDA, and more. Understand the regulatory requirements, submission processes, and timelines for NDA approval in different countries. Filing a New Drug Application (NDA) is an essential process for pharmaceutical companies aiming to introduce new drugs into various global … Read more

The development and introduction of new drugs trough New Drug Applications (NDA) in pharmaceuticals into the market is a rigorous and multi-faceted process that requires regulatory oversight to ensure safety, efficacy, and quality. A crucial component of this process is the New Drug Application (NDA), which is submitted to the U.S. Food and Drug Administration … Read more

Strategies for Contamination control is one of the most critical aspects of pharmaceutical manufacturing, particularly in the production of sterile products. Ensuring a contamination-free environment is paramount to maintaining product safety, efficacy, and quality. With the variety of contamination sources, such as the environment, personnel, and materials, a structured and well-planned contamination control strategy becomes … Read more

Handling an FDA inspection in pharmaceuticals is a critical task for pharmaceutical companies. With a rising number of warning letters being issued, preparing for and properly managing an FDA audit has become more challenging. The consequences of a failed inspection can be significant, ranging from production halts to reputational damage. To help navigate this complex … Read more

Product failure in the pharmaceutical industry is a multifaceted issue, fraught with significant financial, regulatory, and ethical ramifications. The complexity of drug development, coupled with the stringent requirements for safety, efficacy, and compliance, makes pharmaceutical product failure a costly and potentially life-threatening problem. Understanding the causes of these failures and implementing remedies is crucial to … Read more

High-Performance Liquid Chromatography and HPLC Detectors is a critical tool in analytical chemistry for separating, identifying, and quantifying compounds in mixtures. The detector is a vital component of HPLC systems, responsible for identifying and quantifying the solutes as they elute from the column. It converts chemical or physical properties of the analytes into measurable signals. … Read more

A Quality Management System (QMS) and its benefits play a crucial role in the pharmaceutical industry by ensuring that materials, products, and services are consistently delivered with the requisite quality and safety. It provides a structured framework that integrates procedures, policies, resources, and objectives to guide an organization toward achieving compliance with regulatory requirements and … Read more

Chromatography plays a pivotal role in the pharmaceutical industry, difference between HPLC and GC techniques in pharmaceutical industries, where precise separation and analysis of compounds are crucial this way. Among the various chromatography techniques, High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) are the most widely used for their ability to separate complex mixtures into … Read more

Designing an air conditioning or duct designing system is a pivotal step in ensuring the efficiency and comfort of an HVAC installation within a given space. A well-constructed system not only maximizes comfort but also significantly reduces energy costs. Conversely, an improperly designed system can lead to inefficiencies, increased energy consumption, and diminished user satisfaction. … Read more