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. 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.