Quality Control and Regulatory Aspects for Biologicals

This book serves as a comprehensive guide on quality control and regulatory aspects for biological products. It covers a wide range of topics, including regulatory requirements, quality control strategies, analytical methods, and risk management.

Auteur

Dr Gauri Misra is working as a scientist and the Head of the Molecular Diagnostics and COVID-19 Kit Testing Laboratory at the National Institute of Biologicals (Ministry of Health and Family Welfare), Noida. She is significantly contributing towards quality control regulation of biologicals, ensuring the release of only quality biologicals in the Indian market, thus safeguarding public health and promoting access to good quality biological products and healthcare. She has extensive experience in the field of molecular diagnostics and cancer biology. She has completed her doctorate from the Central Drug Research Institute, Lucknow and postdoctoral studies at the CHUL Research Centre, Quebec. She has been the recipient of many awards at different stages of her career. She has published more than 30 research articles in highly reputed, peer-reviewed journals, five international books, and six chapters. She has been invited as a speaker at various national and international institutes.