Pharmaceutical Quality Assurance And Management
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| Author | : Oliver Schmidt |
| Publisher | : CRC Press |
| Total Pages | : 393 |
| Release | : 2000-04-30 |
| Genre | : Medical |
| ISBN | : 142002602X |
When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built. With terms such as quality system, quality assurance, and quality management used interchangeably, even defining the system's objectives is a problem. This book provides a pr
| Author | : David Roesti |
| Publisher | : John Wiley & Sons |
| Total Pages | : 594 |
| Release | : 2020-01-02 |
| Genre | : Technology & Engineering |
| ISBN | : 1119356075 |
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 | : K P Bhusari |
| Publisher | : Pharmamed Press |
| Total Pages | : 578 |
| Release | : 2018-12-05 |
| Genre | : Business & Economics |
| ISBN | : 9789385433276 |
The global market associated with pharmaceuticals has progressed enormously since last few decades. The quality and economy of a pharmaceutical product became an essential aspect for its existence and fulfillment of global requirements. It is also a concern for various regulatory agencies all over the world. Pharmaceutical manufacturer has to produce the products that meet the prescribed standards of certain international regulatory agencies and local government. These agencies provide guidelines and set various regulations for the pharmaceutical manufacturers to get quality products. In concern with all these facts, 'quality assurance' and 'quality management' became a specialized area of study that deals with the practices to be adopted during the manufacturing of pharmaceuticals. This book deals with all the elements of quality assurance and management. Salient Features: -Presented the information in condensed and cohesive form -Covers different validation protocols for various processes, methods and equipments involved in the manufacturing -Involved pharmaceutical inspections, various regulatory acts Explained the quality management system and its role
| Author | : Mr. Manohar A. Potdar |
| Publisher | : Pragati Books Pvt. Ltd. |
| Total Pages | : 424 |
| Release | : 2006 |
| Genre | : Pharmaceutical industry |
| ISBN | : 9788185790596 |
| Author | : Anjaneyulu Marayya |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2018-06 |
| Genre | : Business & Economics |
| ISBN | : 9788188449149 |
QA is the most vital function of Total Quality Management (TQM) in pharmaceutical industry. This book presents the basic concepts on various topics like QMS, GLP, GMP, Quality Audit, Statistical Quality Control and analytica methods for QA. The elements, requirement and interpretation of ISO 9000 series of QMS are presented in detail.
| Author | : Guy Wingate |
| Publisher | : CRC Press |
| Total Pages | : 773 |
| Release | : 2016-04-19 |
| Genre | : Medical |
| ISBN | : 1420088955 |
Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.
| Author | : K P R Chowdary |
| Publisher | : |
| Total Pages | : 212 |
| Release | : 2019-12-05 |
| Genre | : Medical |
| ISBN | : 9789389354966 |
| Author | : Kate McCormick |
| Publisher | : Routledge |
| Total Pages | : 289 |
| Release | : 2016-04-22 |
| Genre | : Business & Economics |
| ISBN | : 1317081404 |
A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.
| Author | : Sarwar Beg |
| Publisher | : Academic Press |
| Total Pages | : 450 |
| Release | : 2019-03-27 |
| Genre | : Medical |
| ISBN | : 0128163720 |
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 | : Manohar A Potdar |
| Publisher | : Pharmamed Press |
| Total Pages | : 280 |
| Release | : 2017-08-08 |
| Genre | : Medical |
| ISBN | : 9789385433610 |
In managing the Quality, why we do something is more important than what we do. The purpose of this book is to explain this basis of Quality management to those who need to know in pharmaceutical industry. This book explains the above view with reference to pharma industry with the help of principles of quality advocated by the genius like Dr. Joseph Juran in simple to understand language. The book will be very useful to the postgraduate students of pharmacy and practicing quality managers in pharma industry.
