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How to Validate a Pharmaceutical Process

Jezik EngleskiEngleski
Knjiga Meki uvez
Knjiga How to Validate a Pharmaceutical Process Steven Ostrove
Libristo kod: 02931378
Nakladnici Elsevier Science Publishing Co Inc, lipanj 2016
How to Validate a Pharmaceutical Process, part of the Expertise in Pharmaceutical Process Technology... Cijeli opis
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How to Validate a Pharmaceutical Process, part of the Expertise in Pharmaceutical Process Technology series, provides a “how to” approach to developing and implementing a sustainable pharmaceutical process validation program. This latest entry in the series addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. It contains numerous case studies throughout and covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more. This book illustrates the methods and reasoning behind processes and protocols. Understanding the “why” is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation. Thoroughly referenced and based on the latest research and literatureAddresses practical problems and offers solutions to qualify and validate a pharmaceutical processIllustrates the most common issues related to developing and implementing a sustainable process validation program and provides valuable examples on how to be successfulContains numerous case studies throughout and covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more

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Informacije o knjizi

Puni naziv How to Validate a Pharmaceutical Process
Autor Steven Ostrove
Jezik Engleski
Uvez Knjiga - Meki uvez
Datum izdanja 2016
Broj stranica 218
EAN 9780128041482
ISBN 012804148X
Libristo kod 02931378
Nakladnici Elsevier Science Publishing Co Inc
Težina 376
Dimenzije 230 x 153 x 14

Kategorija

Medicine & Nursing > Medical specialties, branches of medicine > Pharmacology
Technology, Engineering, Agriculture > Industrial chemistry & manufacturing technologies > Other manufacturing technologies
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