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Author: José Rodríguez-Pérez Publisher: Quality Press ISBN: 0873898699 Category : Business & Economics Languages : en Pages : 246
Book Description
This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.
Author: José Rodríguez-Pérez Publisher: Quality Press ISBN: 0873898699 Category : Business & Economics Languages : en Pages : 246
Book Description
This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.
Author: Joseph D. Nally Publisher: CRC Press ISBN: 1420020935 Category : Medical Languages : en Pages : 418
Book Description
With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.
Author: Thomas Friedli Publisher: Springer Nature ISBN: 3030727408 Category : Business & Economics Languages : en Pages : 363
Book Description
Using site-specific optimization approaches in international manufacturing networks is increasingly proving insufficient. To solve this problem, several holistic and integrated alternatives have been developed to reflect a global perspective. This book presents advances in the St. Gallen Global Manufacturing Network Model and its application in numerous industry-, benchmarking- and research projects. The contents combine data-driven solutions with qualitative management frameworks for the strategic optimization of international manufacturing networks. In the first part, the book addresses the foundation of manufacturing network management and further describes the St. Gallen Operational Excellence approaches to manage plant performance. On this basis, the authors show how plant- and network-level performance can be enhanced via key improvement domains (e.g., strategy, configuration, coordination, performance management, digitalization). In turn, the second part demonstrates the application of the constructs in manufacturing companies from various industries. By combining research and practice, the book offers unique perspectives on the management of global production striving toward higher performance on manufacturing site and network level.
Author: Institute of Food Science and Technology Publisher: John Wiley & Sons ISBN: 1119388449 Category : Technology & Engineering Languages : en Pages : 389
Book Description
The latest updated edition of the market-leading guide to Good Manufacturing Practice (GMP) in the food and drink industry This all-new, 7th edition of Food and Drink - Good Manufacturing Practice: A Guide to its Responsible Management features a wealth of new information reflecting changes in the industry and advances in science that have occurred since the publication of the last edition back in 2013. They include topics such as: Food Safety Culture, Food Crime and Food Integrity Management Systems, Food Crime Risk Assessment including vulnerability risk assessment and Threat Analysis Critical Control Point (TACCP), Security and Countermeasures, Food Toxins, Allergens and Risk Assessment, Provenance and authenticity, Electronic and digital traceability technologies, Worker Welfare Standards; Smart Packaging, Food Donation Controls and Animal Food Supply, Safety Culture; Provenance and integrity testing and Sustainability Issues. In addition to the new topics mentioned above, Food and Drink - Good Manufacturing Practice, 7th Edition offers comprehensive coverage of information in chapters on Quality Management System; Hazard Analysis Critical Control Point (HACCP); Premises and Equipment; Cleaning and Sanitation; Product Control, Testing and Inspection; Heat Preserved Foods; Frozen Foods; Foods for Catering and Vending Operations; and much more. Comprises both general guidance and food sector-specific requirements for good manufacturing practice Incorporates all the most recent developments and changes in UK and EU law Provides a readable and accessible reference for busy managers in the food industry Food and Drink - Good Manufacturing Practice: A Guide to its Responsible Management, 7th Edition is a valuable reference for anyone in a managerial or technical capacity concerned with the manufacture, storage, and distribution of food and drink. The book is also a “must –read” for the recommended reading lists for food science, food technology and food policy undergraduate and postgraduate studies. IFST - the Institute of Food Science and Technology is the leading qualifying body for food professionals in Europe and the only professional qualifying body in the UK concerned with all aspects of food science and technology.
Author: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 0309498635 Category : Medical Languages : en Pages : 169
Book Description
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Author: S. Sethi Publisher: Springer ISBN: 0230348572 Category : Business & Economics Languages : en Pages : 303
Book Description
Corporate strategy expert Prakash Sethi takes an in-depth look at global structures and how regulation works from a corporate perspective, providing case studies of several industries and governments who have begun implementing voluntary codes of conducts, including Equator Principles, ICMM, and The Kimberly Process.
Author: Dwivedi, Ashish Publisher: IGI Global ISBN: 1799828697 Category : Business & Economics Languages : en Pages : 333
Book Description
In recent decades, the rapid expansion of trade and investment among developing countries has resulted in a scenario wherein firms from developing countries account for an increasing share of capital, goods, and wealth in the global economy. Industry leaders from developing countries have observed that firms in developing countries need to identify and develop key supply chain capabilities in order to succeed in emerging markets. It is argued that customers in emerging markets are likely to have different needs and supply chain expectations as compared to customers in developed economies. Reaching into these emerging markets, understanding the customer diversity, and translating it into effective segmentation schemes are critical for the efficient design of supply chain operations. Leadership Strategies for Global Supply Chain Management in Emerging Markets is a pivotal reference source that provides vital research on creating efficient supply chain operations in emerging markets. While highlighting topics such as consumer behavior, global operations, and information transparency, this publication investigates the needs of consumers in emerging markets as well as the methods of designing effective operations. This book is ideally designed for supply chain managers, logistics managers, operations and warehousing professionals, industry practitioners, academicians, students, and researchers.
Author: Thomas Friedli Publisher: Springer ISBN: 3642341853 Category : Business & Economics Languages : en Pages : 278
Book Description
The preceding process of globalization and the continuously rising competitive pressure on manufacturing companies in more developed economies unveiled the limits of classical site-focused optimization approaches. The focus of network optimization shifts ever more towards an integrative view of manufacturing networks, striving for a harmonization of the strategy-, configuration- and coordination levels. This book presents such an integrative approach to the strategic management of manufacturing networks. Besides strategic network requirements, this book discusses the derivation of an optimal global footprint and the optimization of network coordination activities. Special attention is paid to the site roles concept, especially to the concept of 'lead factory'. A large number of up-to-date cases from the producing industry enrich the book and provide the reader with vivid examples for the application of the presented concepts. Hence, this book is a must-read for both practitioners and academic researchers.
Author: Mary Hallward-Driemeier Publisher: World Bank Publications ISBN: 1464811938 Category : Business & Economics Languages : en Pages : 288
Book Description
Technology and globalization are threatening manufacturing’s traditional ability to deliver both productivity and jobs at a large scale for unskilled workers. Concerns about widening inequality within and across countries are raising questions about whether interventions are needed and how effective they could be. Trouble in the Making? The Future of Manufacturing-Led Development addresses three questions: - How has the global manufacturing landscape changed and why does this matter for development opportunities? - How are emerging trends in technology and globalization likely to shape the feasibility and desirability of manufacturing-led development in the future? - If low wages are going to be less important in defining competitiveness, how can less industrialized countries make the most of new opportunities that shifting technologies and globalization patterns may bring? The book examines the impacts of new technologies (i.e., the Internet of Things, 3-D printing, and advanced robotics), rising international competition, and increased servicification on manufacturing productivity and employment. The aim is to inform policy choices for countries currently producing and for those seeking to enter new manufacturing markets. Increased polarization is a risk, but the book analyzes ways to go beyond focusing on potential disruptions to position workers, firms, and locations for new opportunities. www.worldbank.org/futureofmanufacturing
Author: José Rodríguez-Pérez
Author: José Rodríguez-Pérez
Author: Joseph D. Nally
Author: Thomas Friedli
Author: Institute of Food Science and Technology
Author: National Academies of Sciences, Engineering, and Medicine
Author: S. Sethi
Author: Dwivedi, Ashish
Author: Vesper
Author: Thomas Friedli
Author: Mary Hallward-Driemeier