Автор: Haider, Syed Imtiaz Название: Cleaning Validation Manual ISBN: 1439826609 ISBN-13(EAN): 9781439826607 Издательство: Taylor&Francis Рейтинг: Цена: 26796.00 р. Наличие на складе: Поставка под заказ.
Автор: Haider, Syed Imtiaz (gulf Pharmaceutical Industries, United Arab Emirates) Название: Cleaning validation manual ISBN: 1138749710 ISBN-13(EAN): 9781138749719 Издательство: Taylor&Francis Рейтинг: Цена: 17609.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
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: Bismuth, Gil Название: Cleaning Validation ISBN: 1574911082 ISBN-13(EAN): 9781574911084 Издательство: Taylor&Francis Рейтинг: Цена: 26796.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Bismuth, Gil , Neumann, Shosh Название: Cleaning Validation ISBN: 0367398923 ISBN-13(EAN): 9780367398927 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Offering a detailed, step-by-step guide to building a compliant cleaning validation program, Cleaning Validation: A Practical Approach covers trends in control, procedures, cleaning agents and tools, sampling techniques, analytical methods, and regulatory issues. The author provides practical examples, database formats, standard operating procedures, work instructions, protocols, and reports. He gives readers the tools they need to develop an effective and manageable program that will not only be acceptable to both US and non-US regulatory authorities but will conserve an organization's time, money, and people resources.
Автор: Rathore, Anurag S. Название: Process Validation in Manufacturing of Biopharmaceuticals ISBN: 1439850933 ISBN-13(EAN): 9781439850930 Издательство: Taylor&Francis Рейтинг: Цена: 30624.00 р. Наличие на складе: Поставка под заказ.
Автор: Eskes Chantra, Whelan Maurice Название: Validation of Alternative Methods for Toxicity Testing ISBN: 3319816128 ISBN-13(EAN): 9783319816128 Издательство: Springer Рейтинг: Цена: 23757.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing.
Автор: Haider, Syed Imtiaz Название: Validation Standard Operating Procedures ISBN: 0367390779 ISBN-13(EAN): 9780367390778 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Поставка под заказ.
Описание: Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.
Автор: Jurgen Moll; Riccardo Colombo Название: Target Identification and Validation in Drug Discovery ISBN: 1627033106 ISBN-13(EAN): 9781627033107 Издательство: Springer Рейтинг: Цена: 15372.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This Methods in Molecular Biology (TM) book details current procedures for identifying and validating new drug targets. Includes methods and approaches covering biochemical, cell based, in vivo models and translational methods, as well as relevant case reports.
Автор: Nema, Sandeep Название: Pharmaceutical Dosage Forms - Parenteral Medications ISBN: 1420086472 ISBN-13(EAN): 9781420086478 Издательство: Taylor&Francis Рейтинг: Цена: 26796.00 р. Наличие на складе: Поставка под заказ.
Автор: L?pez, Orlando Название: 21 CFR Part 11 ISBN: 0367394596 ISBN-13(EAN): 9780367394592 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance.
Автор: Pazhayattil Ajay, Sayeed-Desta Naheed, Fredro-Kumbaradzi Emilija Название: Solid Oral Dose Process Validation, Volume Two: Lifecycle Approach Application ISBN: 3030274837 ISBN-13(EAN): 9783030274832 Издательство: Springer Рейтинг: Цена: 11878.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach. This set is published as a comprehensive solution for solid dose process validation.
Автор: Guy Wingate, Glaxo Smith Kline, Durham, UK Название: Pharmaceutical Computer Systems Validation ISBN: 1420088947 ISBN-13(EAN): 9781420088946 Издательство: Taylor&Francis Рейтинг: Цена: 29093.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Pharmaceutical Computer Systems Validation
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