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Author: Anjaneyulu Marayya Publisher: ISBN: 9788188449149 Category : Business & Economics Languages : en Pages : 0
Book Description
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: Anjaneyulu Marayya Publisher: ISBN: 9788188449149 Category : Business & Economics Languages : en Pages : 0
Book Description
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: Oliver Schmidt Publisher: CRC Press ISBN: 142002602X Category : Medical Languages : en Pages : 392
Book Description
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 ISBN: 1119356075 Category : Technology & Engineering Languages : en Pages : 594
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: World Health Organization Publisher: World Health Organization ISBN: 9789241546195 Category : Business & Economics Languages : en Pages : 250
Book Description
Over the years, the World Health Organization's Expert Committee on Specifications for Pharmaceutical Preparations, originally created to prepare The International Pharmacopoeia, has made numerous recommendations relevant to quality assurance and control for national regulatory and control systems and the implementation of international standards, but for the most part they have only been available in the annexes to various technical reports. In this second of two volumes, those annexes providing guidelines related to good manufacturing practices and to inspection of manufacturers and drug distribution channels have been gathered and revised. Annotation : 2004 Book News, Inc., Portland, OR (booknews.com).
Author: K P Bhusari Publisher: Pharmamed Press ISBN: 9789385433276 Category : Business & Economics Languages : en Pages : 578
Book Description
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: G Welty Publisher: Elsevier ISBN: 190881862X Category : Medical Languages : en Pages : 374
Book Description
Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This title is divided into three parts; the first part discusses the process by which a problem in regulated industry is identified, for example a manufacturing deviation that leads to an adulterated drug product, and reviews the decision-making steps involved in remedying the problem. The second part delves into the staff training requirements of procedures that are thereby revised. The third part expands on this discussion by considering piloting the proposed training module, preparing assessments of trainee proficiency, evaluating the training module, including integrating rigorous evaluative designs with formative program improvement, and documenting the entire effort. Presents a comprehensive view of the field of quality assurance An approach grounded in direct experience Uses diagrams and figures to clarify analytical points
Author: Kathleen E. McCormick Publisher: Butterworth-Heinemann ISBN: 0323994601 Category : Medical Languages : en Pages : 385
Book Description
Quality, second edition, provides comprehensive application of regulatory guidelines and quality concepts and methodologies related to pharmaceutical manufacturing. It is an excellent resource for practitioners, those pursuing pharmaceutical related certifications, and for students trying to learn more about pharmaceutical manufacturing. This book provides the background theory, applied descriptions of the guidelines and concepts, plus questions and problems at the end of the chapters that will help provide practice for the reader to apply the concepts. In this book the authors share their combined 60+ years of extensive practical experience in the industry and in process improvement combined with detailed understanding of the needs of the industry and education system. This book provides real-life examples from industry and guidelines for practical application of tools that can be referenced by operators, engineers, and management.This book is fully revised, updated, and expanded with new content in areas such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools. Fully revised, updated, and expanded new edition Features new topics such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools Includes end-of-chapter summaries and end-of-chapter question and/or problems Provides detailed steps and examples for applying the guidelines and quality tools Written in an accessible style making the content easy to understand and apply
Author: Manohar A Potdar Publisher: Pharmamed Press ISBN: 9789385433610 Category : Medical Languages : en Pages : 280
Book Description
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.
Author: Anjaneyulu Marayya
Author: Anjaneyulu Marayya
Author: Oliver Schmidt
Author: Minal Ghante
Author: Mr. Manohar A. Potdar
Author: David Roesti
Author: World Health Organization
Author: K P Bhusari
Author: G Welty
Author: Kathleen E. McCormick
Author: Manohar A Potdar