Basics of Pharmaceutical Manufacturing and Quality Operations: A Comprehensive Guide, Asif, Erfan Syed ; Usmani, Shahid Bader
Автор: Baudin, Michel , Netland, Torbjorn Название: Introduction to Manufacturing Management ISBN: 0815363192 ISBN-13(EAN): 9780815363194 Издательство: Taylor&Francis Рейтинг: Цена: 10104.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book focuses on the operational and tactical issues related to the engineering and management of manufacturing operations in factories, and the immediate links to suppliers and customers. It provides rich detail on how operations can and should be designed and organized in a factory, and on the management of technology and people.
How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control.
With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing.
Discusses the development of strategy blueprints in the design of continuous processes
Shows how to create process flowsheet models from individual unit operation models
Includes a chapter on characterization methods for materials, the use of statistical methods to analyze material property data, and the use of material databases
Covers the evolving regulatory expectations for continuous manufacturing
Provides readers with ways to more effectively navigate these expectations
Автор: White William Название: Excellence Beyond Compliance ISBN: 1138491470 ISBN-13(EAN): 9781138491472 Издательство: Taylor&Francis Рейтинг: Цена: 6736.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Many companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious kind of noncompliance. Documentation created with compliance as the sole consideration often ends up confusing the employees who must use the documentation.
This book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. This book also never forgets that real people must make any QMS work; the book provides a blueprint for creating a QMS that real people will find useful.
After a review of the challenges that any medical device company faces in the world of today--the multiple sources of QMS requirements--the book poses a question: are we satisfied with the QMS we have now, or could we do better? If we want to do better, this book can help.
This book offers:
Advice that will lead to an effective and efficient QMS.
Detailed guidance on the key decisions to be made regarding the quality system being established.
Detailed ideas on how to execute those decisions.
Up-to-date information on compliance to current regulations and standards and guidance on staying up to date.
Specific examples of procedures.
Information regarding requirements for combination products, such as a drug + device combination.
Advice on incorporating risk management in the QMS.
Автор: Hout, Sam A. Название: Manufacturing of quality oral drug products ISBN: 1032124733 ISBN-13(EAN): 9781032124735 Издательство: Taylor&Francis Рейтинг: Цена: 12554.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book provides an understanding of what is required to engineer and manufacture drug products. It bridges established concepts and provides for a new outlook by concentrating and creating new linkages in the implementation of manufacturing, quality assurance, and business practices related to drug manufacturing and healthcare products. This book fills a gap by providing a connection between drug production and regulated applications. It focuses on drug manufacturing, quality techniques in oral solid dosage, and capsule filling including equipment and critical systems, to control production and the finished products. The book offers a correlation between design strategies and a step-by-step process to ensure the reliability, safety, and efficacy of healthcare products. Fundamentals of techniques, quality by design, risk assessment, and management are covered along with a scientific method approach to continuous improvement in the usage of computerized manufacturing and dependence on information technology and control operations through data and metrics. Manufacturing and Quality Assurance of Oral Pharmaceutical Products: Processing and Safe Handling of Active Pharmaceutical Ingredients (API) is of interest to professionals and engineers in the fields of manufacturing engineering, quality assurance, reliability, business management, process, and continuous improvement, life cycle management, healthcare products manufacturing, pharmaceutical processing, and computerized manufacturing.
Автор: Haider, Syed Imtiaz Название: Quality Control Training Manual ISBN: 1439849943 ISBN-13(EAN): 9781439849941 Издательство: Taylor&Francis Рейтинг: Цена: 26796.00 р. Наличие на складе: Нет в наличии.
Автор: Eugenia Gabriela Carrillo-Cedillo, Jose Antonio Rodriguez-Avila, Karina Cecilia Arredondo-Soto, Jose Manuel Cornejo-Bravo Название: Design of Experiments for Chemical, Pharmaceutical, Food, and Industrial Applications ISBN: 1799815188 ISBN-13(EAN): 9781799815181 Издательство: Mare Nostrum (Eurospan) Рейтинг: Цена: 34234.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Statistics is a key characteristic that assists a wide variety of professions including business, government, and factual sciences. Companies need data calculation to make informed decisions that help maintain their relevance. Design of experiments (DOE) is a set of active techniques that provides a more efficient approach for industries to test their processes and form effective conclusions. Experimental design can be implemented into multiple professions, and it is a necessity to promote applicable research on this up-and-coming method.
Design of Experiments for Chemical, Pharmaceutical, Food, and Industrial Applications is a pivotal reference source that seeks to increase the use of design of experiments to optimize and improve analytical methods and productive processes in order to use less resources and time. While highlighting topics such as multivariate methods, factorial experiments, and pharmaceutical research, this publication is ideally designed for industrial designers, research scientists, chemical engineers, managers, academicians, and students seeking current research on advanced and multivariate statistics.
Автор: Kleinebudde Название: Continuous Manufacturing of Pharmaceuticals ISBN: 1119001323 ISBN-13(EAN): 9781119001324 Издательство: Wiley Рейтинг: Цена: 25970.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Written by twenty-five authors from academia, pharmaceutical industry and Pharmacopeias worldwide, this monograph covers the fundamentals and applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in a practical and didactic manner. The book starts by describing the motivation and the urgent need for the implementation of the QbD framework in pharmaceutical development, along with the definition of its major elements: Quality Target Product Profile (QTTP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs) and the importance of using multivariate methods of Design of Experiments (DOE). The concept of life cycle and regulatory perspectives are discussed. Three chapters are entirely dedicated to DOE theory from screening to optimization designs. Moreover, a comprehensive discussion on modelling and data treatment is presented. Practical aspects of QbD and DOE for pharmaceutical product and process of different dosage forms is included, as well as a practical guide of the input process variables, material attributes, intermediate, and final quality attributes for the most representative pharmaceutical processes. Analytical Quality by Design (AQbD) is also deeply explored, including risk analysis, definitions of Analytical Target Profile (ATP), Method Operable Design Region (MODR) and the life cycle approach, taking into account the compendial and regulatory perspectives. A detailed example of a new chromatographic method for the quality control of a pharmaceutical topical product based on the AQbD procedure is shown. Finally, advanced statistical approaches and DOE methods for extraction studies of bioactive compounds are also presented. The vast amount of information offered in this book provides a comprehensive perspective on QbD, AQbD and DOE principles, essential tools for modern pharmaceutical and analytical development.
Описание: Explores, through innovative studies, case studies, systematic literature reviews, and reports, the key developments in digital entrepreneurship, circular economy and digitalization, digital business models, digital marketing and internationalization, digital economy, digital learning, trends and challenges, and digital entrepreneurial ecosystems.
Автор: Akers, Michael J. Название: Sterile Drug Products ISBN: 0849339936 ISBN-13(EAN): 9780849339936 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Название: Validating Pharmaceutical Systems ISBN: 0367392380 ISBN-13(EAN): 9780367392383 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
All too often, the words computer validation strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements and provides guidance from seasoned practitioners on how to fulfill them. John Andrews and his team tackle the perceived complexities surrounding the validation of a wide variety of automated systems.
Sprinkled with case studies and real-life examples, the book offers a step-by-step review of topics such as planning, design, auditing, risk management, and specification. The in-depth, by example coverage demystifies the challenges of manufacturing execution systems(MES), laboratory information management systems(LIMS), and network qualification. The first section examines the different levels of automated systems used throughout the drug development, manufacture, and delivery lifecycle, using the GAMP 4 lifecycle approach to their validation. The second section uncovers some real-life applications of GAMP 4 to different areas of the regulations such as GLP, GCP, GMP, and GDP. The book explores some of the latest thinking on computer validation and reflects changes that have occurred in the industry since the early days of validation. The contributors are a deliberate blend of those who have faced the problems of the 1990s and the Y2K controversies and those who have more recently arrived on the scene and made an impact on the perception of validation of automated systems across the field of GxP. They do more than show you how to do the right thing; they show you how to do the right thing in compliance with regulations.
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