Good Laboratory And Clinical Practices Techniques For The Quality Assurance
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Author | : Philip Carson |
Publisher | : Royal Society of Chemistry |
Total Pages | : 657 |
Release | : 2007-10-31 |
Genre | : Science |
ISBN | : 1847557724 |
Download Good Clinical, Laboratory and Manufacturing Practices Book in PDF, Epub and Kindle
Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.
Author | : Phillip A. Carson |
Publisher | : Royal Society of Chemistry |
Total Pages | : 657 |
Release | : 2007 |
Genre | : Science |
ISBN | : 0854048340 |
Download Good Clinical, Laboratory and Manufacturing Practices Book in PDF, Epub and Kindle
Provides practical advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of preclinical safety studies, clinical trials and manufacture of drugs. This book also offers a framework for integrating these standards with other quality management systems.
Author | : Phillip A. Carson |
Publisher | : Butterworth-Heinemann |
Total Pages | : 424 |
Release | : 1990 |
Genre | : Medical |
ISBN | : |
Download Good Laboratory and Clinical Practices Book in PDF, Epub and Kindle
This book provides practical and detailed advice for the quality assurance professional who is responsible for monitoring compliance with legal requirements and accepted standards and guidelines. This manual is useful for those subject to inspection and audit, such as toxicologists, ecotoxicologists, technicians, analysts, chemists, clinicians, and process managers.
Author | : Milton A Anderson |
Publisher | : |
Total Pages | : |
Release | : 1994 |
Genre | : |
ISBN | : 9789994014156 |
Download Good Laboratory and Clinical Practices Techniques for the Quality Assurance Book in PDF, Epub and Kindle
Author | : P Carson |
Publisher | : CRC Press |
Total Pages | : 352 |
Release | : 1994-06-30 |
Genre | : Medical |
ISBN | : 9780750619578 |
Download Good Laboratory & Clinical Practices Book in PDF, Epub and Kindle
GLP regulations concern the quality and integrity of safety data generated in industrial laboratories, in environmental studies and in the development of new chemical substances. They deal with such matters as: * selection and training of staff * the handling of test materials * choice of test method * quality of measurements * maintenance and calibration of equipment * sample and data curation Similar principles are adopted for assuring the quality of clinical research practice and of the manufacture of certain consumer products: GCRP applies mainly to the pharmaceuticals industry; GMP was introduced primarily to control the quality of drugs in manufacture. The same standards are becoming adopted in other personal product areas such as cosmetics, toiletries and dental products. These principles and requirements are increasingly applied also to work carried out in support of studies governed by `good practice' standards, such as characterization and chemical analysis. The twenty-seven chapters have been written by a team of recognized world experts. Phillip Carson, PhD, MSc, AMCT, CChem, MIOSH, is Safety Liaison and Quality Assurance Manager at the Port Sunlight Research Laboratory of Unilever. He is a member of the QA (UK) Group's Working Party on Ecotoxicology, of the IChemE's `Loss Prevention Panel' and of the Chemical Industries Association's `Health Advisory Group' and `Exposure Limits Task Force' and past chairman of their Hygiene Working Group. Nigel Dent, a qualityassurance consultant to the pharmaceuticals and chemical industries, was a founder member of the Quality Assurance Group (UK). He is Regional Director (Europe) for the International Society for Quality Assurance and a member of its Executive Council. Mr Dent was formerly Research QA Manager for Hoechst UK Pharmaceuticals and has over 21 years' experience in the pharmaceuticals industry and with contract research organizations.
Author | : Sandy Weinberg |
Publisher | : CRC Press |
Total Pages | : 256 |
Release | : 2002-11-06 |
Genre | : Medical |
ISBN | : 0824745647 |
Download Good Laboratory Practice Regulations, Third Edition, Revised and Expanded Book in PDF, Epub and Kindle
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general guidelines for the management of efficient and effective research environment. A guide to the current standards and requirements of good laboratory management, the book examines essential theoretical principles for anticipating new and emerging interpretations of GLP in a variety of laboratory settings.
Author | : Sandy Weinberg |
Publisher | : CRC Press |
Total Pages | : 249 |
Release | : 2002-11-06 |
Genre | : Medical |
ISBN | : 0203911083 |
Download Good Laboratory Practice Regulations, Revised and Expanded Book in PDF, Epub and Kindle
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general g
Author | : Graham Ogg |
Publisher | : CRC Press |
Total Pages | : 229 |
Release | : 2005-11-01 |
Genre | : Medical |
ISBN | : 104006163X |
Download A Practical Guide to Quality Management in Clinical Trial Research Book in PDF, Epub and Kindle
Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a co
Author | : Jürg P. Seiler |
Publisher | : Springer Science & Business Media |
Total Pages | : 404 |
Release | : 2012-12-06 |
Genre | : Medical |
ISBN | : 3642868789 |
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After more than twenty years of use Good Laboratory Practice, or GLP, has attained a secure place in the world of testing chemicals and other "test items" with regard to their safety for humans and the environment. Gone are the days when the GLP regulations were hotly debated amongst scientists in academia and industry and were accused of stifling flexibility in, imaginative approaches to, and science-based conduct of, all kinds of studies concerned with toxic effects and other parameters important for the evaluation and assessment of products submitted for registration and permission to market. The GLP regulations have developed from rules on how to exactly document the planning, conduct and reporting of toxicity studies to a quality system for the management of a multitude of study types, from the simple determination of a physical/chemical parameter to the most complex field tests or ecotoxicology studies. At the same time the term "Good Laboratory Practice" has become somewhat of a slogan with the aim to characterise any reliably conducted laboratory work.
Author | : Akshay Anand |
Publisher | : Springer Nature |
Total Pages | : 247 |
Release | : 2021-08-17 |
Genre | : Medical |
ISBN | : 9811630747 |
Download Quality Assurance Implementation in Research Labs Book in PDF, Epub and Kindle
This book is a comprehensive and timely compilation of strategy, methods, and implementation of a proof of concept modified quality module of Good Laboratory Practices (GLP). This text provides a historical overview of GLP and related standards of quality assurance practices in clinical testing laboratories as well as basic research settings. It specifically discusses the need and challenges in audit, documentation, and strategies for its implications in system-dependent productivity striving research laboratories. It also describes the importance of periodic training of study directors as well as the scholars for standardization in research processes. This book describes different documents required at various time points of a successful Ph.D and post-doc tenure along with faculty training besides entire lab establishments. Various other areas including academic social responsibility and quality assurance in the developing world, lab orientations, and communication, digitization in data accuracy, auditability and back traceability have also been discussed. This book will be a preferred source for principal investigators, research scholars, and industrial research centers globally. From the foreword by Ratan Tata, India “This book will be a guide for students and professionals alike in quality assurance practices related to clinical research labs. The historical research and fundamental principles make it a good tool in clinical research environments. The country has a great need for such a compilation in order to increase the application of domestic capabilities and technology”