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: 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.
Название: Good Manufacturing Practices Pharma ISBN: 1498732062 ISBN-13(EAN): 9781498732062 Издательство: Taylor&Francis Рейтинг: Цена: 28327.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.
Key Features:
Presents insight into the world of pharmaceutical quality systems
Analyzes regulatory trends and expectations
Includes approaches and practices used in the industry to comply with regulatory requirements
Discusses recent worldwide supply chain issues
Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry
Название: Validating Pharmaceutical Systems ISBN: 0367392380 ISBN-13(EAN): 9780367392383 Издательство: Taylor&Francis Рейтинг: Цена: 10411.00 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.
Автор: Sharp, John Название: Good Pharmaceutical Manufacturing Practice ISBN: 0849319943 ISBN-13(EAN): 9780849319945 Издательство: Taylor&Francis Рейтинг: Цена: 29093.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Andrews, John Название: Validating Pharmaceutical Systems ISBN: 084932324X ISBN-13(EAN): 9780849323249 Издательство: Taylor&Francis Рейтинг: Цена: 30624.00 р. Наличие на складе: Нет в наличии.
Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing field
Biomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature--and it's rarely taught in architecture or design schools. This is the first book for architects and designers that fills this void. Process Architecture in Biomanufacturing Facility Design provides information on design principles of biopharmaceutical manufacturing facilities that support emerging innovative processes and technologies, use state-of-the-art equipment, are energy efficient and sustainable, and meet regulatory requirements.
Relying on their many years of hands-on design and operations experience, the authors emphasize concepts and practical approaches toward design, construction, and operation of biomanufacturing facilities, including product-process-facility relationships, closed systems and single use equipment, aseptic manufacturing considerations, design of biocontainment facility and process based laboratory, and sustainability considerations, as well as an outlook on the facility of the future.
Provides guidelines for meeting licensing and regulatory requirements for biomanufacturing facilities in the U.S.A and WHO--especially in emerging global markets in India, China, Latin America, and the Asia/Pacific regions
Focuses on innovative design and equipment, to speed construction and time to market, increase energy efficiency, and reduce footprint, construction and operational costs, as well as the financial risks associated with construction of a new facility prior to the approval of the manufactured products by regulatory agencies
Includes many diagrams that clarify the design approach
Process Architecture in Biomanufacturing Facility Design is an ideal text for professionals involved in the design of facilities for manufacturing of biopharmaceuticals and vaccines, biotechnology, and life-science industry, including architects and designers of industrial facilities, construction, equipment vendors, and mechanical engineers. It is also recommended for university instructors, advanced undergraduates, and graduate students in architecture, industrial engineering, mechanical engineering, industrial design, and industrial interior design.
Автор: Merkus Название: Particles and Nanoparticles in Pharmaceutical Products ISBN: 3319941739 ISBN-13(EAN): 9783319941738 Издательство: Springer Рейтинг: Цена: 14025.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This edited volume brings together the expertise of numerous specialists on the topic of particles - their physical, chemical, pharmacological and toxicological characteristics - when they are a component of pharmaceutical products and formulations.
Описание: This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.
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: Ingrid Walker Название: High: Drugs, Desire, and a Nation of Users ISBN: 0295742313 ISBN-13(EAN): 9780295742311 Издательство: Mare Nostrum (Eurospan) Рейтинг: Цена: 13794.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Whether drinking Red Bull, relieving chronic pain with oxycodone, or experimenting with Ecstasy, Americans participate in a culture of self-medication, using psychoactive substances to enhance or manage our moods. A “drug-free America” seems to be a fantasyland that most people don’t want to inhabit.
High: Drugs, Desire, and a Nation of Users asks fundamental questions about US drug policies and social norms. Why do we endorse the use of some drugs and criminalize others? Why do we accept the necessity of a doctor-prescribed opiate but not the same thing bought off the street? This divided approach shapes public policy, the justice system, research, social services, and health care. And despite the decades-old war on drugs, drug use remains relatively unchanged.
Ingrid Walker speaks to the silencing effects of both criminalization and medicalization, incorporating first-person narratives to show a wide variety of user experiences with drugs. By challenging current thinking about drugs and users, Walker calls for a next wave of drug policy reform in the United States, beginning with recognizing the full spectrum of drug use practices.
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