Sterile Manufacturing: Regulations, Processes, and Guidelines - Softcover

Hout, Sam A.

Softcover

ISBN 10: 0367754371 ISBN 13: 9780367754372

Publisher: CRC Press, 2024

Synopsis

This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products.

Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning.

The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.

Edition details

• Publisher: CRC Press
• Publication date: 2024
• Language: English
• ISBN 10: 0367754371
• ISBN 13: 9780367754372
• Binding: Paperback
• Edition number: 1
• Number of pages: 190