Quality Culture in the Pharmaceutical Industry PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Quality Culture in the Pharmaceutical Industry PDF full book. Access full book title Quality Culture in the Pharmaceutical Industry by Jose (Pepe) Rodríguez-Pérez. Download full books in PDF and EPUB format.
Author: Jose (Pepe) Rodríguez-Pérez
Publisher:
ISBN: 9781736742907
Category :
Languages : en
Pages :
Get Book Here
Book Description
Why so many pharmaceutical companies are struggling to meet GMP and other regulatory requirements?The reason is clear: because they are trying to improve their quality management systems by fixing symptoms rather than by attacking the fundamental and primary root cause of their problems which is the lack of adequate quality and compliance culture.The purpose of this book is to provide those leaders and senior managers with a clear roadmap to solve their regulatory problems and to return to the route of compliance by implementing a strong, positive quality and compliance culture. The recipe is simple: all you need is good people (including good leaders and senior managers), good procedures and good training programs sailing into a strong and positive culture of quality and compliance.When a company implements a behavior-based quality and culture compliance, they look into their problems as a whole, and they understand that there are multiple factors (including the soft ones related to personal and organizational behaviors) that affect performance. A very positive consequence of this systematic thinking is the shift from CAPA programs mostly correctives to ones where the systemic preventive actions are predominant.Quality is everyone's responsibility, but when it comes to creating, strengthening, or maintaining a culture within an organization, there is one group who really owns it: the leaders and senior managers.The good news is that creating or strengthening a positive and sustainable quality culture is an achievable task although not an easy or quick one. In this book you will find ten foundational principles of a strong and positive quality culture, their associated desired behaviors and a set of leading indicators that can be used to monitor and enhance leadership engagement, people engagement, and culture and maturity.
Author: Jose (Pepe) Rodríguez-Pérez
Publisher:
ISBN: 9781736742907
Category :
Languages : en
Pages :
Get Book Here
Book Description
Why so many pharmaceutical companies are struggling to meet GMP and other regulatory requirements?The reason is clear: because they are trying to improve their quality management systems by fixing symptoms rather than by attacking the fundamental and primary root cause of their problems which is the lack of adequate quality and compliance culture.The purpose of this book is to provide those leaders and senior managers with a clear roadmap to solve their regulatory problems and to return to the route of compliance by implementing a strong, positive quality and compliance culture. The recipe is simple: all you need is good people (including good leaders and senior managers), good procedures and good training programs sailing into a strong and positive culture of quality and compliance.When a company implements a behavior-based quality and culture compliance, they look into their problems as a whole, and they understand that there are multiple factors (including the soft ones related to personal and organizational behaviors) that affect performance. A very positive consequence of this systematic thinking is the shift from CAPA programs mostly correctives to ones where the systemic preventive actions are predominant.Quality is everyone's responsibility, but when it comes to creating, strengthening, or maintaining a culture within an organization, there is one group who really owns it: the leaders and senior managers.The good news is that creating or strengthening a positive and sustainable quality culture is an achievable task although not an easy or quick one. In this book you will find ten foundational principles of a strong and positive quality culture, their associated desired behaviors and a set of leading indicators that can be used to monitor and enhance leadership engagement, people engagement, and culture and maturity.
Author: José Rodríguez Pérez
Publisher: Quality Press
ISBN: 0873898346
Category : Business & Economics
Languages : en
Pages : 289
Get Book Here
Book Description
Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. The U.S. Food and Drug Administration (FDA) and its worldwide counterparts are responsible for protecting public health by ensuring the safety and effectiveness of the drugs and medical devices. Regulators must decide whether the benefits of a specific product for patients and users outweigh its risk, while recognizing that absolute safety (or zero risk) is not achievable. Every product and every process has an associated risk. Although there are some examples of the use of quality risk management in the FDA-regulated industry today, they are limited and do not represent the full contribution that risk management has to offer. The present FDA focus on risk-based determination is requiring that the regulated industries improve dramatically their understanding and capability of hazard control concepts. In addition, the importance of quality systems has been recognized in the life sciences industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system. The purpose of this book is to offer a systematic and very comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practices or good laboratory practices. The content of this book will provide FDA-regulated manufacturers with a framework within which experience, insight, and judgment are applied systematically to manage the risks associated with their products. Manufacturers in other industries may use it as an informative guidance in developing and maintaining a risk management system and process. The two appendices add even more insight: Appendix A contains general examples of risk management, while Appendix B includes 10 case studies illustrating real examples of the quality risk management process across the medical product arena.
Author: Sarwar Beg
Publisher: Academic Press
ISBN: 0128163720
Category : Medical
Languages : en
Pages : 450
Get Book Here
Book Description
Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. - Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries - Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers - Includes contributions from global leaders and experts from academia, industry and regulatory agencies
Author: John Braithwaite
Publisher: Routledge
ISBN: 1135072906
Category : Social Science
Languages : en
Pages : 451
Get Book Here
Book Description
First published in 1984, this book examines corporate crime in the pharmaceutical industry. Based on extensive research, including interviews with 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala, the book is a major study of white-collar crime. Written in the 1980s, it covers topics such as international bribery and corruption, fraud in the testing of drugs and criminal negligence in the unsafe manufacturing of drugs. The author considers the implications of his findings for a range of strategies to control corporate crime, nationally and internationally.
Author: Walkiria S. Schlindwein
Publisher: John Wiley & Sons
ISBN: 1118895215
Category : Science
Languages : en
Pages : 319
Get Book Here
Book Description
A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.
Author: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
Get Book Here
Book Description
Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Author: Márcia Cristina Breitkreitz
Publisher: Springer Nature
ISBN: 3031315057
Category : Medical
Languages : en
Pages : 268
Get Book Here
Book Description
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.
Author: Howard Brody
Publisher: Rowman & Littlefield
ISBN: 9780742552180
Category : Business & Economics
Languages : en
Pages : 390
Get Book Here
Book Description
For decades, medical professionals have betrayed the public's trust by accepting various benefits from the pharmaceutical industry. Both drug company representatives and doctors employ artful spin to portray this behavior positively to the public, and to themselves. In Hooked, Howard Brody argues that we can neither understand the problem, nor propose helpful solutions until we identify the many levels of activity connecting these purportedly noble industries. We can pass laws and enact regulations, but ultimately the medical profession must take responsibility for its own integrity. Hooked is a wake-up call for anyone expecting high quality, ethical medical care.
Author: Nuala Calnan
Publisher: CRC Press
ISBN: 1315351366
Category : Medical
Languages : en
Pages : 357
Get Book Here
Book Description
This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation’s knowledge assets can provide a path towards business excellence.
Author: James P. Womack
Publisher:
ISBN: 9781934109380
Category : Business & Economics
Languages : en
Pages : 0
Get Book Here
Book Description
In 12 new essays, ranging from the provocative to the practical and written specially for the second edition of Gemba Walks author and management expert Jim Womack reflects on the past 30 years of lean, and assesses the current state of lean today.He also shares thoughts on how lean thinking and practice can continue to make the world a better place by gaining traction in areas such as government and healthcare, provides practical guidance for how leaders everywhere can realize the full benefits of a lean management system, and shares hope for continued improvement on the path to better work and more value.Over the past 30 years, Womack has developed a method of going to visit the gemba at countless companies and keenly observing how people work together to create value. He has shared his thoughts and discoveries from these visits with the lean community through a monthly letter. With Gemba Walks second edition, Womack has selected and re-organized his key letters, as well as written 12 new essays.Gemba Walks shares his insights on topics ranging from the application of specific tools, to the role of management in sustaining lean, as well as the long-term prospects for this fundamental new way of creating value. Reading this book will reveal to readers a range of lean principles, as well as the basis for the critical lean practice of: go see, ask why, and show respect.Womack explains: - whatever happened to Toyota and what happens next to lean?- how lean got its name 25 years ago; a special essay co-authored by Jim and John Krafcik, president and CEO, Hyundai Motors America- work, management, and leadership -- what is the real work of the lean leader?- don't offshore or reshore -leanshore- why companies need fewer heroes and more farmers (who work daily to improve the processes and systems needed for perfect work and who take the time and effort to produce long-term improvement)- how "good" people who work in "bad" processes become as "bad" as the process itself- how the real practice of showing respect comes down to helping workers frame and solve their own problems- how the short-term gains from lean tools can be translated to enduring change from lean management.- how the lean manager has a "restless desire to continually rethink the organization's problems, probe their root causes, and lead experiments to test the best currently known countermeasures"By sharing his personal path of discovery, Womack sheds new light on the continued adoption and development of the most important new business system of the past fifty years. His journey will provide courage and inspiration for every lean practitioner today.
