Pharmaceutical Calibration, Validation and Qualification: A Comprehensive Approach, Shukla
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
Описание: The demand for traditional medicines, herbal health products, herbal pharmaceuticals, nutraceuticals, food supplements and herbal cosmetics etc.
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.
Автор: Ostrove, Steven Название: Ostrove - Equipment Qualification in the Pharmaceutical Industry ISBN: 0128175680 ISBN-13(EAN): 9780128175682 Издательство: Elsevier Science Рейтинг: Цена: 16505.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems.
Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols.
Incorporates good manufacturing processes into a compliant qualification program
Provides examples of protocol layout
Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements
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.
Описание: The demand for traditional medicines, herbal health products, herbal pharmaceuticals, nutraceuticals, food supplements and herbal cosmetics etc.
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: Huber, Ludwig Название: Validation and Qualification in Analytical Laboratories ISBN: 084938267X ISBN-13(EAN): 9780849382673 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Kowalski, Tony Название: Calibration in the Pharmaceutical Laboratory ISBN: 1574910922 ISBN-13(EAN): 9781574910926 Издательство: Taylor&Francis Рейтинг: Цена: 18374.00 р. Наличие на складе: Поставка под заказ.
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