Quality Control and Regulatory Aspects for Biologicals

ISBN-13: 9781032697406 / Twarda / 2024 / 208 str.

Opis

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.

Spis treści

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

 

O autorze

Dr. Gauri Misra is working as scientist and the Head of the Molecular Diagnostics and COVID-19 Kit Testing Laboratory at 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 Indian market thus safeguarding the public health and promoting access to good quality biological products and healthcare. She has an extensive experience in the field of Molecular Diagnostics and Cancer Biology. She has completed her doctorate from Central Drug Research Institute, Lucknow and postdoctoral studies at CHUL Research Centre, Quebec. She is the recipient of many awards at different stages of her career.