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Author : Mr. Manohar A. Potdar
Publisher : Pragati Books Pvt. Ltd.
ISBN 13 : 9788185790596
Total Pages : 424 pages
Book Rating : 4.7/5 (95 download)
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:
Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9789241546195
Total Pages : 250 pages
Book Rating : 4.5/5 (461 download)
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).
Author : Minal Ghante
Publisher : Springer Nature
ISBN 13 : 9819992710
Total Pages : 525 pages
Book Rating : 4.8/5 (199 download)
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:
Author : Oliver Schmidt
Publisher : CRC Press
ISBN 13 : 142002602X
Total Pages : 392 pages
Book Rating : 4.4/5 (2 download)
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
Author : K P R Chowdary
Publisher :
ISBN 13 : 9789389354966
Total Pages : 212 pages
Book Rating : 4.3/5 (549 download)
Download or read book A Textbook of Pharmaceutical Quality Assurance written by K P R Chowdary and published by . This book was released on 2019-12-05 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : G Welty
Publisher : Elsevier
ISBN 13 : 190881862X
Total Pages : 374 pages
Book Rating : 4.9/5 (88 download)
Download or read book Quality Assurance written by G Welty and published by Elsevier. This book was released on 2013-06-30 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : David Roesti
Publisher : John Wiley & Sons
ISBN 13 : 1119356075
Total Pages : 594 pages
Book Rating : 4.1/5 (193 download)
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
Author : Guy Wingate
Publisher : CRC Press
ISBN 13 : 1420088955
Total Pages : 798 pages
Book Rating : 4.4/5 (2 download)
Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 798 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 r
Author : R. Baird
Publisher : CRC Press
ISBN 13 : 1135743630
Total Pages : 272 pages
Book Rating : 4.1/5 (357 download)
Download or read book Microbial Quality Assurance in Pharmaceuticals, Cosmetics, and Toiletries written by R. Baird and published by CRC Press. This book was released on 2017-12-14 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: The importance of quality assurance in the production, storage and use of manufactured preparations is widely recognized. This book encapsulates the issues involved in the manufacture of non-steriles, such as creams, ointments, herbal remedies, shampoos, soaps and toiletry products (as opposed to sterile drugs and injectible products). Knowledge of the microbial limits is expanded, new standards are included, and coverage of the preservation issues of dosage forms is widened to include semi-solids and liquid preparations. This edition also contains new regulations regarding preservative efficacy testing and covers pharmacopoeial and industry regulations and guidelines. Rapid methods are also discussed, now more common in cosmetic and toiletry practice, in their pharmaceutical capacity.
Author : Anjaneyulu Marayya
Publisher :
ISBN 13 : 9788188449149
Total Pages : 0 pages
Book Rating : 4.4/5 (491 download)
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.
Author : Murray Sam Cooper
Publisher :
ISBN 13 :
Total Pages : 312 pages
Book Rating : 4.3/5 (91 download)
Download or read book Quality Control in the Pharmaceutical Industry written by Murray Sam Cooper and published by . This book was released on 1972 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : B.P. Nagori
Publisher : Scientific Publishers
ISBN 13 : 938774101X
Total Pages : 268 pages
Book Rating : 4.3/5 (877 download)
Download or read book Pharmaceutical Quality Assurance written by B.P. Nagori and published by Scientific Publishers. This book was released on 2018-01-01 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: he present state-of-art book has been written as per the new syllabus of B. Pharmacy, introduced by Pharmacy Council of India (PCI). This book has an inclusive content that covers the wider aspects of pharmaceutical quality assurance required by under- graduates, post graduates, industry personnels, researcher, and students preparing for various competitive exams. The distinguishing feature of this book is that the book is written in lucid, simple and easy to understand language. The book is accompanied with Multiple Choice, Fill in the Blank, True-False, Short Answer and Long Answer type of questions for the self- evluation of learning. The answers of the Multiple Choice, Fill in the Blank and True-False questions have also been given. Web links/further reading are included to help the readers for keeping themselves abreast with th latest developments in the held of pharmaceutical quality assurance. Academicians and instructors in universities/colleges may use the book as primary or additional teaching material for under-graduate and post-graduate pharmacy courses.
Author : Dr. Santosh Karajgi , Dr. Shripad S Potadar , Dr. Sudha Patil , Mr. Ajay Shahapur , Ms. Maharani H Bhandarakavathe
Publisher : Shashwat Publication
ISBN 13 : 936087258X
Total Pages : 290 pages
Book Rating : 4.3/5 (68 download)
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.
Author : Sarwar Beg
Publisher : Academic Press
ISBN 13 : 0128163720
Total Pages : 448 pages
Book Rating : 4.1/5 (281 download)
Download or read book Pharmaceutical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2019-03-27 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Steve L. Nail
Publisher : Springer Science & Business Media
ISBN 13 : 1461505496
Total Pages : 479 pages
Book Rating : 4.4/5 (615 download)
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.
Author : K P Bhusari
Publisher : Pharmamed Press
ISBN 13 : 9789385433276
Total Pages : 578 pages
Book Rating : 4.4/5 (332 download)
Download or read book Pharmaceutical Quality Assurance and Management written by K P Bhusari and published by Pharmamed Press. This book was released on 2018-12-05 with total page 578 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Institute of Quality Assurance
Publisher : Twayne Publishers
ISBN 13 : 9780906810781
Total Pages : 24 pages
Book Rating : 4.8/5 (17 download)
Download or read book The Elements and Philosophy of Pharmaceutical Quality Assurance written by Institute of Quality Assurance and published by Twayne Publishers. This book was released on 2001 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
