Sterile Manufacturing

Sterile Manufacturing

EnglishEbook
Hout, Sam A.
CRC Press
EAN: 9781000406092
Available online
CZK 1,504
Common price CZK 1,671
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Detailed information

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.
EAN 9781000406092
ISBN 1000406091
Binding Ebook
Publisher CRC Press
Publication date July 4, 2021
Pages 206
Language English
Country Uruguay
Authors Hout, Sam A.
Manufacturer information
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