Sterile Manufacturing: Regulations, Processes, and Guidelines - Image 1

£78.93

CRC Press Sterile Manufacturing: Regulations, Processes, and Guidelines

Name: Sterile Manufacturing: Regulations, Processes, and Guidelines
Brand: CRC Press
Price: 78.59 GBP
Availability: InStock

Mechanical & Material Engineering

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Description

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.

Product Specifications

Brand: CRC Press
Format: hardcover
ASIN: 0367754355
Category: Books > Subjects > Scientific, Technical & Medical > Engineering > Mechanical & Material Engineering
Domain: Amazon UK
Release Date: 05 July 2021
Listed Since: 09 January 2021

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CRC Press Sterile Manufacturing: Regulations, Processes, and Guidelines

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