Автор: LeBlanc, Destin A. Название: Cleaning Validation ISBN: 1032430834 ISBN-13(EAN): 9781032430836 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 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.
Название: Biotechnology ISBN: 0367400251 ISBN-13(EAN): 9780367400255 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Biotechnology: Quality Assurance and Validation provides a practical, detailed discussion of what issues Quality Assurance and Quality Control need to identify for effective control in the preparation of biotechnology products. The book presents a series of topics that define some of the unique challenges facing biotechnology companies in producing biopharmaceutical products. The topics selected address quality and validation issues, starting with the cryopreservation of cell lines through the filling and finishing of the product. It includes a validation guide, a clear presentation of how to use filtration effectively, a synoptic view of cleaning procedures, and much more.
Автор: Riley, Christopher M. Название: Riley - Spec of Drug Substances and Products, 2e ISBN: 0081028245 ISBN-13(EAN): 9780081028247 Издательство: Elsevier Science Рейтинг: Цена: 28633.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered-or not substantially covered-in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products.
The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.
Presents a critical assessment of the application of ICH guidelines on method validation and specification setting
Written by subject-matter experts involved in the development and application of the guidelines
Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products
Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction
Автор: Pazhayattil Ajay Babu, Sayeed-Desta Naheed, Fredro-Kumbaradzi Emilija Название: Solid Oral Dose Process Validation: The Basics, Volume 1 ISBN: 3030024717 ISBN-13(EAN): 9783030024710 Издательство: Springer Рейтинг: Цена: 13974.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance’s, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.
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
While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment validation. The author provides a thorough understanding of how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst case scenario.
No other book deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment-and provides instructions on how to achieve it. With pragmatic approach, this book includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols. Step-by-step, they show how to qualify each piece of equipment, and they provide a check for readers own protocols.
Описание: Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement. Compliance is a state of being in
Автор: Scotti Название: Drug Target Selection and Validation ISBN: 3030958949 ISBN-13(EAN): 9783030958947 Издательство: Springer Рейтинг: Цена: 19564.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The first book in the newly created book series, Computer-Aided Drug Discovery and Design, focuses on the computational aspects of early drug discovery, drug target identification, and validation.
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.
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