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Sterile Manufacturing
- Regulations, Processes, and Guidelines
Engelsk
Foto på vej
Specifikationer
Sprog:
Engelsk
Sider:
190
ISBN-13:
9780367754358
Indbinding:
Hardback
Udgave:
ISBN-10:
0367754355
Kategori:
Udg. Dato:
5 jul 2021
Længde:
19mm
Bredde:
243mm
Højde:
160mm
Forlag:
Taylor & Francis Ltd
Oplagsdato:
5 jul 2021
Forfatter(e):

Sterile Manufacturing

- Regulations, Processes, and Guidelines
Engelsk
Hardback
Format:

Om denne bog

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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Specifikationer
Sprog:
Engelsk
Sider:
190
ISBN-13:
9780367754358
Indbinding:
Hardback
Udgave:
ISBN-10:
0367754355
Kategori:
Udg. Dato:
5 jul 2021
Længde:
19mm
Bredde:
243mm
Højde:
160mm
Forlag:
Taylor & Francis Ltd
Oplagsdato:
5 jul 2021
Forfatter(e):
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