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.
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, Manikalt
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