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Sterile Manufacturing - Regulations, Processes, and Guidelines (Hardcover) Loot Price: R2,415
Discovery Miles 24 150
Sterile Manufacturing - Regulations, Processes, and Guidelines (Hardcover): Sam A. Hout

Sterile Manufacturing - Regulations, Processes, and Guidelines (Hardcover)

Sam A. Hout

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Loot Price R2,415 Discovery Miles 24 150 | Repayment Terms: R226 pm x 12*

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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.

General

Imprint: Crc Press
Country of origin: United Kingdom
Release date: July 2021
First published: 2022
Authors: Sam A. Hout
Dimensions: 234 x 156 x 19mm (L x W x T)
Format: Hardcover
Pages: 190
ISBN-13: 978-0-367-75435-8
Categories: Books > Business & Economics > Business & management > Business strategy
Books > Business & Economics > Industry & industrial studies > Manufacturing industries > Pharmaceutical industries
Books > Medicine > Other branches of medicine > Environmental medicine > Occupational medicine
Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > General
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LSN: 0-367-75435-5
Barcode: 9780367754358

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