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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 : Eugenia Gabriela Carrillo-Cedillo
Publisher :
ISBN 13 : 9781799896142
Total Pages : pages
Book Rating : 4.8/5 (961 download)
Download or read book Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry written by Eugenia Gabriela Carrillo-Cedillo and published by . This book was released on 2022 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: "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
ISBN 13 : 9241547081
Total Pages : 414 pages
Book Rating : 4.2/5 (415 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 2007 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control and in the pharmaceutical industry. This is the second updated edition of the compendium and includes texts published in 2005 and 2006 in the WHO Technical Report Series.
Author : Pulok K. Mukherjee
Publisher : Elsevier
ISBN 13 : 0128133988
Total Pages : 784 pages
Book Rating : 4.1/5 (281 download)
Download or read book Quality Control and Evaluation of Herbal Drugs written by Pulok K. Mukherjee and published by Elsevier. This book was released on 2019-05-30 with total page 784 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality Control and Evaluation of Herbal Drugs brings together current thinking and practices for evaluation of natural products and traditional medicines. The use of herbal medicine in therapeutics is on the rise in both developed and developing countries and this book facilitates the necessary development of quality standards for these medicines.This book elucidates on various challenges and opportunities for quality evaluation of herbal drugs with several integrated approaches including metabolomics, chemoprofiling, marker analysis, stability testing, good practices for manufacturing, clinical aspects, Ethnopharmacology and Ethnomedicine inspired drug development. Written by Prof. Pulok K Mukherjee, a leader in this field; the book highlights on various methods, techniques and approaches for evaluating the purity, quality, safety and efficacy of herbal drugs. Particular attention is paid to methods that assess these drugs’ activity, the compounds responsible and their underlying mechanisms of action. The book describes the quality control parameters followed in India and other countries, including Japan, China, Bangladesh, and other Asian countries, as well as the regulatory profiles of the European Union and North America. This book will be useful in bio-prospecting of natural products and traditional medicine-inspired drug discovery and development. Provides new information on the research and development of natural remedies - essential reading on the study and use of natural resources for preventative or healing purposes Brings together current thinking and practices in quality control and standardization of herbal drugs highlighting several integrated approaches for metabolomics, chemo-profiling and marker analysis Aids in developing knowledge of various techniques including macroscopy, microscopy, HPTLC, HPLC, LC-MS/MS, GC-MS etc. with the development of integrated methods for evaluation of botanicals used in traditional medicine Assessment of herbal drugs through bio-analytical techniques, bioassay guided isolation, enzyme inhibition, pharmacological, microbiological, antiviral assays and safety related quality issues References global organizations, such as the WHO, USFDA, CDSCO, AYUSH, TCM and others to serve as a comprehensive document for enforcement agencies, NGOs and regulatory authorities
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 : 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 : Rosamund M. Baird
Publisher : CRC Press
ISBN 13 : 0203305191
Total Pages : 274 pages
Book Rating : 4.2/5 (33 download)
Download or read book Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices written by Rosamund M. Baird and published by CRC Press. This book was released on 2000-08-17 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9241545100
Total Pages : 122 pages
Book Rating : 4.2/5 (415 download)
Download or read book Quality Control Methods for Medicinal Plant Materials written by World Health Organization and published by World Health Organization. This book was released on 1998 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt: A collection of test procedures for assessing the identity, purity, and content of medicinal plant materials, including determination of pesticide residues, arsenic and heavy metals. Intended to assist national laboratories engaged in drug quality control, the manual responds to the growing use of medicinal plants, the special quality problems they pose, and the corresponding need for international guidance on reliable methods for quality control. Recommended procedures - whether involving visual inspection or the use of thin-layer chromatography for the qualitative determination of impurities - should also prove useful to the pharmaceutical industry and pharmacists working with these materials.
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 : D. Nally Joseph
Publisher : CRC Press
ISBN 13 : 0824741935
Total Pages : 752 pages
Book Rating : 4.8/5 (247 download)
Download or read book Good Manufacturing Practices for Pharmaceuticals written by D. Nally Joseph and published by CRC Press. This book was released on 2000-10-12 with total page 752 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Iqbal Ahmad
Publisher : John Wiley & Sons
ISBN 13 : 3527609539
Total Pages : 404 pages
Book Rating : 4.5/5 (276 download)
Download or read book Modern Phytomedicine written by Iqbal Ahmad and published by John Wiley & Sons. This book was released on 2006-12-13 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: This timely and original handbook paves the way to success in plant-based drug development, systematically addressing the issues facing a pharmaceutical scientist who wants to turn a plant compound into a safe and effective drug. Plant pharmacologists from around the world demonstrate the potentials and pitfalls involved, with many of the studies and experiments reported here published for the first time. The result is a valuable source of information unavailable elsewhere.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309498635
Total Pages : 169 pages
Book Rating : 4.3/5 (94 download)
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
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 : P.B. Deasy
Publisher : Elsevier
ISBN 13 : 1483165027
Total Pages : 413 pages
Book Rating : 4.4/5 (831 download)
Download or read book The Quality Control of Medicines written by P.B. Deasy and published by Elsevier. This book was released on 2014-05-21 with total page 413 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Rhys Bryant
Publisher :
ISBN 13 :
Total Pages : 232 pages
Book Rating : 4.3/5 (91 download)
Download or read book The Pharmaceutical Quality Control Handbook written by Rhys Bryant and published by . This book was released on 1984 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Yukihiro Shoyama
Publisher : BoD – Books on Demand
ISBN 13 : 9533076828
Total Pages : 296 pages
Book Rating : 4.5/5 (33 download)
Download or read book Quality Control of Herbal Medicines and Related Areas written by Yukihiro Shoyama and published by BoD – Books on Demand. This book was released on 2011-11-04 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: The authors of this thematic issue provide a comprehensive summary of most recent knowledge and references on quality control in wide fields. Quality control is essential for natural products like natural medicine and related food products. In this issue fifteen chapters have been included, discussing in detail various aspects of quality control. It will certainly prove useful not only for phytochemical researchers, but also many scientists working in numerous fields. Much effort has been invested by the contributors to share current information. Without their efforts and input 'Quality Control of Herbal Medicine and Related Areas' could not exist.
Author : Ravindra Kumar Pandey
Publisher : CRC Press
ISBN 13 : 0429682824
Total Pages : 214 pages
Book Rating : 4.4/5 (296 download)
Download or read book Fingerprinting Analysis and Quality Control Methods of Herbal Medicines written by Ravindra Kumar Pandey and published by CRC Press. This book was released on 2018-07-03 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt: Due to the increase in the consumption of herbal medicine, there is a need to know which scientifically based methods are appropriate for assessing the quality of herbal medicines. Fingerprinting has emerged as a suitable technique for quality estimation. Chemical markers are used for evaluation of herbal medicines. Identification and quantification of these chemical markers are crucial for quality control of herbal medicines. This book provides updated knowledge on methodology, quality assessment, toxicity analysis and medicinal values of natural compounds.
