Quality Assurance And Quality Management In Pharmaceutical Industry
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| 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 | : 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 | : 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.
| Author | : Y. Anjaneyulu |
| Publisher | : Pharmamed Press |
| Total Pages | : 380 |
| Release | : 2018-12-07 |
| Genre | : Technology & Engineering |
| ISBN | : 9789352300730 |
Quality Assurance (QA) is a measure of the degree of sophistication of managerial, scientific and technical tools used in the design and implementation of product process of any industry. 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 analytical methods for QA. The elements, requirement and interpretation of ISO 9000 series of QMS are presented in detail. The principles of GLP and GMP are discussed which are expected to guide the manufacturer and the regulator for maintaining high scientific and professional standards for ensuring only drugs of highest quality are produced and marketed. Each chapter is provided with a summary and typical questions and in Appendix, the latest information on the International Standards of QMS, GLP and GMP are included for ready reference. "As very few books are available on this important subject, this book will be very useful as text book for students of both graduate and post-graduate classes in Pharmacy, Analytical Chemistry and allied subjects. It shall serve as ready reference for scientific and management personnel working in various pharmaceutical industries for understanding the basic concep
| Author | : Mr. Manohar A. Potdar |
| Publisher | : Pragati Books Pvt. Ltd. |
| Total Pages | : 424 |
| Release | : 2006 |
| Genre | : Pharmaceutical industry |
| ISBN | : 9788185790596 |
| Author | : Steve L. Nail |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 479 |
| Release | : 2012-12-06 |
| Genre | : Medical |
| ISBN | : 1461505496 |
In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality.
| 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 | : K P R Chowdary |
| Publisher | : |
| Total Pages | : 212 |
| Release | : 2019-12-05 |
| Genre | : Medical |
| ISBN | : 9789389354966 |
| 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.
