Quality Control and Regulatory Aspects for Biologicals

Regulations and Best Practices
1. Auflage 2024
ISBN: 978-1-032-69740-6
Verlag: CRC Press

Buch, Englisch, 208 Seiten, Format (B × H): 152 mm x 229 mm, Gewicht: 449 g

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.

Zielgruppe

Academic, Professional Practice & Development, and Professional Reference

Autoren/Hrsg.

Misra, Gauri

Fachgebiete

• Technische Wissenschaften Sonstige Technologien | Angewandte Technik Medizintechnik, Biomedizintechnik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizintechnik, Biomedizintechnik, Medizinische Werkstoffe
• Technische Wissenschaften Maschinenbau | Werkstoffkunde Produktionstechnik Industrielle Qualitätskontrolle
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie

Inhaltsverzeichnis

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

Über Autor(innen)

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.