ISPE Good Practice Guide PDF Download
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Author:
Publisher:
ISBN: 9781931879569
Category : Pharmaceutical industry
Languages : en
Pages : 104
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Book Description
Author:
Publisher:
ISBN: 9781931879569
Category : Pharmaceutical industry
Languages : en
Pages : 104
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Book Description
Author: Ispe
Publisher:
ISBN: 9781946964120
Category :
Languages : en
Pages : 176
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Book Description
Author: Ispe
Publisher:
ISBN: 9781946964175
Category :
Languages : en
Pages : 204
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Book Description
Author: International Society of Pharmaceutical Engineers
Publisher:
ISBN: 9781936379422
Category : Laboratories
Languages : en
Pages : 172
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Book Description
Author: Ispe
Publisher:
ISBN: 9781946964144
Category :
Languages : en
Pages : 148
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Book Description
Author: Ispe
Publisher:
ISBN: 9781931879361
Category :
Languages : en
Pages : 80
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Book Description
Author: ISPE
Publisher:
ISBN: 9781931879255
Category : Technology & Engineering
Languages : en
Pages : 19
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Book Description
Author: Sam A. Hout
Publisher: CRC Press
ISBN: 1000406091
Category : Technology & Engineering
Languages : en
Pages : 206
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Book 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.
Author: Ispe
Publisher:
ISBN: 9781936379989
Category :
Languages : en
Pages : 128
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Book Description
Author:
Publisher:
ISBN: 9781936379064
Category : Pharmaceutical industry
Languages : en
Pages : 135
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Book Description
