1st Edition
Quality Control and Regulatory Aspects for Biologicals Regulations and Best Practices
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
Index
Biography
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.
