Cleaning Validation, Bismuth, Gil , Neumann, Shosh

Автор: Haider, Syed Imtiaz (gulf Pharmaceutical Industries, United Arab Emirates)
Название: Cleaning validation manual
ISBN: 1138749710 ISBN-13(EAN): 9781138749719
Издательство: Taylor&Francis
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Цена: 17609.00 р.
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Описание: With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors` more than two decades of experience, the text offers hands-on training based on current approaches

Автор: Eskes
Название: Validation of Alternative Methods for Toxicity Testing
ISBN: 3319338242 ISBN-13(EAN): 9783319338248
Издательство: Springer
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Цена: 23508.00 р.
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Описание: This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology. Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment. This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing.

Автор: LeBlanc, Destin A.
Название: Validated Cleaning Technologies for Pharmaceutical Manufacturing
ISBN: 0367398877 ISBN-13(EAN): 9780367398873
Издательство: Taylor&Francis
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Цена: 9798.00 р.
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Описание: Written by an expert especially for those who must design validatable cleaning processes and then must validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.