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Sterile Manufacturing
Af: Sam A. Hout Engelsk Hardback
SPAR
kr 141
Sterile Manufacturing
Af: Sam A. Hout Engelsk Hardback

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.

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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.

Produktdetaljer
Sprog: Engelsk
Sider: 190
ISBN-13: 9780367754358
Indbinding: Hardback
Udgave:
ISBN-10: 0367754355
Kategori: Arbejdsmedicin
Udg. Dato: 5 jul 2021
Længde: 19mm
Bredde: 160mm
Højde: 243mm
Oplagsdato: 5 jul 2021
Forfatter(e): Sam A. Hout
Forfatter(e) Sam A. Hout


Kategori Arbejdsmedicin


Sprog Engelsk


Indbinding Hardback


Sider 190


Udgave


Længde 19mm


Bredde 160mm


Højde 243mm


Oplagsdato 5 jul 2021

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