Modern Aspects of Pharmaceutical Quality Assurance PDF Download

Author: Minal Ghante
Publisher: Springer Nature
ISBN: 9819992710
Category :
Languages : en
Pages : 525

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Book Description

Author: Minal Ghante
Publisher: Springer
ISBN: 9789819992706
Category : Medical
Languages : en
Pages : 0

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Book Description
The pharmaceutical quality system ensures that the process performance is suitably achieved, the product quality is regularly met, improved opportunities are identified and evaluated, and the knowledge is constantly expanded. Auditing also plays a crucial role within the pharmaceutical industry. It helps to assess and review quality to improve and build a better system for the benefit of companies. This book aims to develop a tool that will substantially decrease the number of Inspectional Observations and Warning letters, thus eliminating Import Alerts and Consent Decree. This book targets the Pharmaceutical Industry and students of Pharmaceutical Quality Assurance so they can get in hand-ready consolidated information on Pharmaceutical Quality guidelines, Quality metrics, and implementation of simplified SOP guidelines, plant layouts to implement Quality metrics for Pharmaceutical Manufacturing systems in tablets, capsules, liquid orals, and semi-solid dosage forms. The chapters cover the various aspects of Pharmaceutical Quality Assurance. The selection of topics is mainly based on the requirements of Pharmaceutical regulatory guidelines of India, the UK, the USA, Australia, and South Africa. Each chapter includes the abstract, detailed explanation, implementation guidelines, flowcharts, layouts, and Standard Operating Procedure of quality metrics for the Pharmaceutical Manufacturing System

Author: Walkiria S. Schlindwein
Publisher: John Wiley & Sons
ISBN: 1118895207
Category : Science
Languages : en
Pages : 375

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Book Description
A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

Author: World Health Organization
Publisher: World Health Organization
ISBN: 9789241546195
Category : Business & Economics
Languages : en
Pages : 250

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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: Institute of Quality Assurance
Publisher: Twayne Publishers
ISBN: 9780906810781
Category : Chemical engineering
Languages : en
Pages : 24

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Author: B.P. Nagori
Publisher: Scientific Publishers
ISBN: 938774101X
Category : Medical
Languages : en
Pages : 268

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Book Description
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 held 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: Pharmaceutical Quality Group
Publisher:
ISBN: 9780906810248
Category : Pharmaceutical industry
Languages : en
Pages : 18

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Book Description

Author: Murray Sam Cooper
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 312

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Book Description

Author: Mr. Manohar A. Potdar
Publisher: Pragati Books Pvt. Ltd.
ISBN: 9788185790596
Category : Pharmaceutical industry
Languages : en
Pages : 424

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Book Description

Author: Anjaneyulu Marayya
Publisher:
ISBN: 9788188449149
Category : Business & Economics
Languages : en
Pages : 0

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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.