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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.
Book Synopsis Quality Assurance And Quality Management In Pharmaceutical Industry by : Anjaneyulu Marayya
Download or read book Quality Assurance And Quality Management In Pharmaceutical Industry written by Anjaneyulu Marayya and published by . This book was released on 2018-06 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Modern Aspects of Pharmaceutical Quality Assurance by : Minal Ghante
Download or read book Modern Aspects of Pharmaceutical Quality Assurance written by Minal Ghante and published by Springer Nature. This book was released on with total page 525 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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).
Book Synopsis Quality Assurance of Pharmaceuticals by : World Health Organization
Download or read book Quality Assurance of Pharmaceuticals written by World Health Organization and published by World Health Organization. This book was released on 2004 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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).
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
Book Synopsis Pharmaceutical Quality Systems by : Oliver Schmidt
Download or read book Pharmaceutical Quality Systems written by Oliver Schmidt and published by CRC Press. This book was released on 2000-04-30 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
The Pharmacy Council of India's (PCI) revised B. Pharmacy syllabus is followed in this state-of-the-art book. The broader topics of pharmaceutical quality assurance that undergrads, postgrads, industry professionals, researchers, and students getting ready for different competitive tests need to be covered in this book's encompassing content. The writing style of this book is clear, straightforward, and uncomplicated, which sets it apart from others. For the self-evolution of learning, the book is complemented by questions in the formats of multiple choice, fill in the blank, true-false, short answer, and long answer. Additionally included are the solutions to the True-False, Fill in the Blank, and Multiple-Choice problems. Links to websites and recommended reading are provided to assist readers in staying up to date on the most recent advancements in the field of pharmaceutical quality assurance. The book can be used as the main source of instruction or as supplementary material by academicians and teachers at universities and colleges for undergraduate and graduate pharmacy courses.
Book Synopsis Pharmaceutical Quality Assurance: A Textbook by : Dr. Santosh Karajgi , Dr. Shripad S Potadar , Dr. Sudha Patil , Mr. Ajay Shahapur , Ms. Maharani H Bhandarakavathe
Download or read book Pharmaceutical Quality Assurance: A Textbook written by Dr. Santosh Karajgi , Dr. Shripad S Potadar , Dr. Sudha Patil , Mr. Ajay Shahapur , Ms. Maharani H Bhandarakavathe and published by Shashwat Publication. This book was released on 2024-05-07 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Pharmacy Council of India's (PCI) revised B. Pharmacy syllabus is followed in this state-of-the-art book. The broader topics of pharmaceutical quality assurance that undergrads, postgrads, industry professionals, researchers, and students getting ready for different competitive tests need to be covered in this book's encompassing content. The writing style of this book is clear, straightforward, and uncomplicated, which sets it apart from others. For the self-evolution of learning, the book is complemented by questions in the formats of multiple choice, fill in the blank, true-false, short answer, and long answer. Additionally included are the solutions to the True-False, Fill in the Blank, and Multiple-Choice problems. Links to websites and recommended reading are provided to assist readers in staying up to date on the most recent advancements in the field of pharmaceutical quality assurance. The book can be used as the main source of instruction or as supplementary material by academicians and teachers at universities and colleges for undergraduate and graduate pharmacy courses.
Book Synopsis Pharmaceutical Quality Assurance by : Mr. Manohar A. Potdar
Download or read book Pharmaceutical Quality Assurance written by Mr. Manohar A. Potdar and published by Pragati Books Pvt. Ltd.. This book was released on 2006 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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
Book Synopsis Pharmaceutical Microbiological Quality Assurance and Control by : David Roesti
Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
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.
Book Synopsis Concepts of Quality Management in Pharmaceutical Industry by : Manohar A Potdar
Download or read book Concepts of Quality Management in Pharmaceutical Industry written by Manohar A Potdar and published by Pharmamed Press. This book was released on 2017-08-08 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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.
Book Synopsis Development and Manufacture of Protein Pharmaceuticals by : Steve L. Nail
Download or read book Development and Manufacture of Protein Pharmaceuticals written by Steve L. Nail and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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
Book Synopsis Quality by : Kathleen E. McCormick
Download or read book Quality written by Kathleen E. McCormick and published by Butterworth-Heinemann. This book was released on 2022-07-14 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
