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Author : Murray Sam Cooper
Publisher : Unknown
Page : 312 pages
File Size : 43,8 Mb
Release : 1972
Category : Law
ISBN : UOM:39015000816564
Author : Minal Ghante
Publisher : Springer Nature
Page : 525 pages
File Size : 43,8 Mb
Release : 2024-07-02
Category : Electronic
ISBN : 9789819992713
Author : Eugenia Gabriela Carrillo-Cedillo,Karina Cecilia Arredondo-Soto,Kenia Palomino Vizcaino,Héctor Magaña Badilla
Publisher : Unknown
Page : 128 pages
File Size : 44,8 Mb
Release : 2022
Category : Drugs
ISBN : 1799896145
"This book gives the reader an up-to-date overview of the medical device manufacturing process and its influence on current regulations highlighting the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards so as not to cause problems to the health of patients"--
Author : World Health Organization
Publisher : World Health Organization
Page : 250 pages
File Size : 55,7 Mb
Release : 2004
Category : Business & Economics
ISBN : 9241546190
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 : David Roesti,Marcel Goverde
Publisher : John Wiley & Sons
Page : 594 pages
File Size : 44,5 Mb
Release : 2020-01-02
Category : Technology & Engineering
ISBN : 9781119356073
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 : Steve L. Nail,Michael J. Akers
Publisher : Springer Science & Business Media
Page : 479 pages
File Size : 50,6 Mb
Release : 2012-12-06
Category : Medical
ISBN : 9781461505495
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 : P.B. Deasy,R.F. Timoney
Publisher : Elsevier
Page : 413 pages
File Size : 45,5 Mb
Release : 2014-05-21
Category : Medical
ISBN : 9781483165028
The Quality Control of Medicines documents the proceedings of the 35th International Congress of Pharmaceutical Sciences, organized by the Pharmaceutical Society of Ireland on behalf of the Federation Internationale Pharmaceutique, held in Dublin, on 1-5 September 1975. The theme chosen for the Congress was ""the basis for the quality control of medicines"", because of the importance and relevance of quality control in the production and distribution of medicines at national and international levels. This volume is arranged according to the manner in which the theme of the Congress was developed by the eminent invited speakers. Following the inaugural address a main symposium was held where five speakers presented a review of the quality control of medicines under the general headings of (i) chemical and physical aspects; (ii) biological aspects; (iii) control of drug delivery systems; (iv) storage problems; and (v) problems of international control. Certain aspects of the content of the main symposium were then developed in greater depth in parallel symposia. In the first parallel symposium some novel physicochemical aspects of the quality control of medicines were treated under the headings of spectrofluorimetry, mass spectrometry, detection in gas chromatography, and automation in pharmaceutical analysis. The second parallel symposium developed certain microbiological aspects of quality control under the headings of sterility testing and microbiological control of non-sterile products and ophthalmic preparations. The final symposium on submissions to regulatory bodies and international aspects of drug control covered aspects of politics in submissions, regulatory problems in small countries, and various pharmacopoeial problems.
Author : Mr. Manohar A. Potdar
Publisher : Pragati Books Pvt. Ltd.
Page : 424 pages
File Size : 53,7 Mb
Release : 2006
Category : Pharmaceutical industry
ISBN : 8185790590
Author : Anjaneyulu Marayya
Publisher : Unknown
Page : 0 pages
File Size : 51,5 Mb
Release : 2018-06
Category : Business & Economics
ISBN : 8188449148
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 : Manohar A Potdar
Publisher : Pharmamed Press
Page : 280 pages
File Size : 53,7 Mb
Release : 2017-08-08
Category : Medical
ISBN : 938543361X
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 : Kenneth Harburn
Publisher : CRC Press
Page : 200 pages
File Size : 50,5 Mb
Release : 2019-08-30
Category : Electronic
ISBN : 0367403102
Illustrates the use of systems such as in-process control, quality auditing, and specifications, stressing a troubleshooting, cost-effective approach to product packaging for maximized early lead time to the customer. Addressing the needs of the pharmaceutical industry, the approaches supplied are l
Author : Oliver Schmidt
Publisher : CRC Press
Page : 392 pages
File Size : 52,8 Mb
Release : 2000-04-30
Category : Medical
ISBN : 9781420026023
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 : Rosamund M. Baird,Norman A. Hodges,Stephen P. Denyer
Publisher : CRC Press
Page : 274 pages
File Size : 55,8 Mb
Release : 2000-08-17
Category : Medical
ISBN : 9780203305195
Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by provi
Author : D. Nally Joseph
Publisher : CRC Press
Page : 752 pages
File Size : 48,5 Mb
Release : 2000-10-12
Category : Medical
ISBN : 9780824741938
Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. The book recommend pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria. They focus on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers.
Author : Dipak Kumar Sarker
Publisher : John Wiley & Sons
Page : 204 pages
File Size : 46,9 Mb
Release : 2008-07-31
Category : Science
ISBN : 9780470773048
Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models. Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, statistics, microbiology, biotechnology, engineering, business practice and optimizing models, the law and safeguarding public health, innovation and inventiveness and contemporary best practice. The author has both industry and academic experience and many ‘best practice’ examples are included throughout the text based on his own industry experience and current practicing industrial pharmacists. This is an invaluable reference for all students of pharmacy who may have little or no familiarity with industrial practice and for those studying BSc chemistry, biomedical sciences, process analytical chemistry and MSc in Industrial Practice.