Sterile Manufacturing: Regulations, Processes, and Guidelines

This book is a comprehensive guide for professionals involved in sterile manufacturing, covering regulations, aseptic techniques, quality by design, risk assessment, and management. It provides a link between design strategies and business practices, and connects drug production to regulated applications. It is a valuable resource for pharmacists, GMP inspectors, and auditors.

Format: Hardback
Length: 190 pages
Publication date: 05 July 2021
Publisher: Taylor & Francis Ltd

This comprehensive book delves into the realm of sterile manufacturing, providing valuable insights and guidance for professionals involved in this field. It encompasses a wide range of topics, including regulations and guidelines set forth by esteemed organizations such as the FDA, ISPE, EMA, MHRA, and ICH. The book emphasizes the importance of good manufacturing practice and inspection requirements in the production of medicinal products, ensuring the safety and efficacy of these critical healthcare products.

Furthermore, the book offers a solid foundation in aseptic techniques, quality by design, risk assessment, and management, all essential components of sterile operations applications. It establishes a connection between design strategies and the implementation of business practices in drug manufacturing and healthcare, highlighting the significance of reliability, safety, and efficacy in healthcare products for human and animal use.

The book also provides a comprehensive review of the basic elements of sterile processing, shedding light on how to remain viable in a competitive market through solid strategic planning. Its scope extends beyond the pharmaceutical and medical device space, encompassing food and cosmetics industries that require clean (aseptic) manufacturing applications. Additionally, the book serves as a valuable resource for compounding pharmacists, GMP inspectors, and auditors, aiding in their understanding of sterile manufacturing principles and practices.

In summary, this book is a must-read for professionals and learners seeking to excel in the field of sterile manufacturing. It offers a comprehensive and in-depth understanding of the industry, covering regulations, guidelines, aseptic techniques, quality by design, risk assessment, and management. By leveraging its insights, individuals can enhance their skills and contribute to the development of safe and effective healthcare products.

Weight: 456g
Dimension: 160 x 243 x 19 (mm)
ISBN-13: 9780367754358