Category: Pharmaceutical Guidance

Uncovering the Secrets of HPLC Method Development: A Comprehensive Guide

High-performance liquid chromatography (HPLC) is a widely used analytical technique in the fields of chemistry, biochemistry, and pharmaceuticals. The method development process of HPLC involves optimizing various parameters to produce reliable and reproducible results. In this article, we will provide

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Top 25 Regulatory Affairs (RA) Interview Questions in Pharmaceutical Industry

What is Regulatory Affairs? Regulatory Affairs in the pharmaceutical industry, is a profession that acts as the interface between the pharmaceutical industry and drug regulatory authorities across the world. It is mainly involved in the registration of the drug products

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Six Sigma Belts and levels | Certification types in Six Sigma

“Explore the comprehensive guide to Six Sigma methodologies, including DMAIC, CTQ Tree, and Root Cause Analysis. Learn about the various Six Sigma certification levels – White Belt, Yellow Belt, Green Belt, Black Belt, Master Black Belt, and Champion. Discover the integration of Lean principles and Design for Six Sigma (DFSS). Gain insights into the certification process offered by ASQ and IASSC. Elevate your understanding of quality management, process improvement, and data-driven decision-making in the world of Six Sigma.”

Six Sigma and Lean Six sigma: Principle and Difference

he Six Sigma methodology gives businesses the tools they need to strengthen the capacity of their operational procedures. This improvement in performance and decrease in process variance contributes to the reduction of defects as well as an improvement in revenue, employee morale, and product or service

Quality by Design (QbD)

“Discover the power of Quality by Design (QbD) and International Council for Harmonisation (ICH) Guidelines in shaping exceptional manufacturing standards. QbD, a proactive approach, ensures product quality from the start by integrating scientific principles into development. Explore the significance of ICH guidelines like Q8, Q9, Q10, and Q11 in aligning pharmaceutical development globally. Delve into frequently asked questions about QbD and ICH, unlocking insights into effective implementation. Elevate your understanding of pharmaceutical quality assurance, drug development principles, and global standards for optimized success. Embrace innovation and compliance with this simplified guide to QbD and ICH.”