1st Edition

Quality Control and Regulatory Aspects for Biologicals Regulations and Best Practices

Edited By Gauri Misra Copyright 2024
    204 Pages 20 Color & 2 B/W Illustrations
    by CRC Press

    204 Pages 20 Color & 2 B/W Illustrations
    by CRC Press

    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. It delves into the advantages and limitations of in vivo tests and discusses alternative methods that can be employed. The book explores the use of animal-based testing methods in quality control and examines viable alternatives.

    Key Features:

    • Reviews various scientific and regulatory aspects involved in the quality control of biologicals
    • Provides an overview of the roles of various national and international regulatory bodies and accreditation agencies
    • Presents advanced analytical methods, innovative technologies, and the integration of molecular diagnostics in quality control processes
    • Explores the use of animal-based testing methods in quality control, as well as their alternatives
    • Discusses guidelines and methodologies involved in the development of biological products

    Overall, this book is an important reference source for various professionals in the pharmaceutical industry, including researchers, scientists, quality control personnel, and regulatory affairs professionals.

    Chapter 1: Regulatory Aspects of Quality Control in Pharmaceuticals

    Shruti Rastogi and Gaurav Pratap Singh Jadaun

    Chapter 2:  Importance of Quality Control in Biologicals

    Ashwini Kumar Dubey and Mahima Gupta

    Chapter 3: Role & Importance of National & International Agencies in Quality Control Regulation

    Md. Arafat Islam

    Chapter 4: Accreditations for Biologicals

    Manjula Kiran

    Chapter 5: Indian Industries and Biologicals

    Archana Upadhyay, Ashrat Manzoor, Brij Bhushan, Shalini Tewari

    Chapter 6: Animal-Based Testing Methods and Their Alternatives In Quality Control Evaluation Of Biologicals

     Anoop Kumar

    Chapter 7: Good Manufacturing Practices In Quality Control

    Bhartendu Sharma, Priyanshi Singh, Supriya Shukla and Gauri Misra

    Chapter 8: The Role Of Analytical Methods In Quality Control Of Biologicals And Stability Testing Of Biological Products

    Khushboo Choudhury and Rashmi Aggarwal

    Chapter 9: Regulatory Bodies: European Medicines Agency (EMA) and Pharmaceutical Inspection Co-operation Scheme (PIC/S)

    Satyajeet Singh, Manika P Sharma and Gauri Misra

    Chapter 10: Quality control considerations specific to the development and production of gene and cell therapies

    Tara Chand and Ashwini Kumar Dubey



    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.