Sterile Manufacturing is popular PDF and ePub book, written by Sam A. Hout in 2021-07-04, it is a fantastic choice for those who relish reading online the Technology & Engineering genre. Let's immerse ourselves in this engaging Technology & Engineering book by exploring the summary and details provided below. Remember, Sterile Manufacturing can be Read Online from any device for your convenience.
Sterile Manufacturing Book PDF Summary
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.
Detail Book of Sterile Manufacturing PDF
- Author : Sam A. Hout
- Release : 04 July 2021
- Publisher : CRC Press
- ISBN : 9781000406122
- Genre : Technology & Engineering
- Total Page : 148 pages
- Language : English
- PDF File Size : 10,7 Mb
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