Sterile manufacturing : regulations, processes, and guidelines / Sam A. Hout
"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"--.
| Medienart: |
Buch |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
Boca Raton London New York: CRC Press, Taylor & Francis Group ; 2022 |
| Ausgabe: |
First edition |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Hout, Sam A. [VerfasserIn] |
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| Links: |
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| ISBN: |
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| BKL: | |
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| Themen: |
Asepsis |
| Anmerkungen: |
Includes bibliographical references and index |
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| Umfang: |
xv, 189 Seiten ; Diagramme |
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| Förderinstitution / Projekttitel: |
|
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| PPN (Katalog-ID): |
1754903460 |
|---|
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| 250 | |a First edition | ||
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| 300 | |a xv, 189 Seiten |b Diagramme | ||
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| 500 | |a Includes bibliographical references and index | ||
| 505 | 8 | 0 | |a Introduction -- Data integrity compliance -- Risk based life cycle management -- FMEA manufacturing procedure -- Classified areas -- Sterile manufacturing facilities -- Personnel behaviors, personal protective equipment (PPE), and process flow -- Quality approach for systems validation -- Dedicated facilities -- Contamination -- Containment -- Suppliers -- Single use technologies (SUT) -- Master qualification plan (MQP) -- Water for injection (WFI) -- Integrated facility design -- Sterile techniques -- Compliance -- Controls -- Barriers, isolators, and RABS -- Quality risk management -- Equipment qualification (EQ) -- Process validation -- Change control -- Analytical testing of raw material quality -- Product life cycle -- Quality by design (QbD) -- Sterilization -- Cleaning validation -- Lyophilization. |
| 520 | |a "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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