Good Automated Laboratory Practices PDF Download

Author:
Publisher: DIANE Publishing
ISBN: 1428906126
Category : Environmental laboratories
Languages : en
Pages : 167

View

Book Description

Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0203911083
Category : Medical
Languages : en
Pages : 249

View

Book Description
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: Sandy Weinberg
Publisher: CRC Press
ISBN: 9781566700252
Category : Science
Languages : en
Pages : 470

View

Book Description
The GALP Regulatory Handbook is an easy-to-use manual to assist laboratories in applying the Good Automated Laboratory Practice guidelines published by the Environmental Protection Agency in 1990. The proliferation of computerized data collection has resulted in new problems of corruption, loss, and inappropriate modification in data provided to the EPA. The EPA published its GALP guidelines to aid laboratories replacing manual operations with computer technology. The eight chapters of this handbook provide a "how-to" framework for complying with those guidelines. The book looks at the extent and seriousness of those control issues for automated data collection systems, the intent of the GALPs in solving and preventing those problems, and the implementation guidelines that can help laboratory management maintain the compliance and quality that are fundamental to effective operation.

Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0824745647
Category : Medical
Languages : en
Pages : 256

View

Book Description
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: Jürg P. Seiler
Publisher: Springer Science & Business Media
ISBN: 3642868789
Category : Medical
Languages : en
Pages : 404

View

Book Description
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: Peter Bedson
Publisher: Royal Society of Chemistry
ISBN: 1847559409
Category : Science
Languages : en
Pages : 420

View

Book Description
Trace Analysis is a highly practical book which deals with the science rather than the paperwork of quality assurance systems. Produced as part of the UK Valid Analytical Measurement (VAM) initiative, it provides the analyst with a systematic approach across the broad spectrum of trace analysis, offering practical advice and guidance on methodology and techniques. The book is structured to take the analyst step-by-step through the stages of any trace analysis. The approach is general, being broken down only into types of analyte. Additional chapters explain the application of groups of techniques to each analyte type. Each section contains references to published material which will allow the analyst to obtain further information on specific topics. Throughout the book, the analyst is reminded of pitfalls which lead to unreliable results. This new book therefore offers invaluable advice to analysts in all areas and at all levels, providing practical 'expert' advice on methodology. It will prove indispensable as a single, comprehensive bench guide for analysts in university, college and industrial laboratories.

Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0849375843
Category : Medical
Languages : en
Pages : 306

View

Book Description
Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresse

Author: Donald C. Singer
Publisher: Quality Press
ISBN: 0873891090
Category : Business & Economics
Languages : en
Pages : 401

View

Book Description
Based on the work of a collection of experts from the laboratory science and quality assurance fields, A Laboratory Quality Handbook of Best Practices and Relevant Regulations provides all of the information needed to run a successful laboratory that is in compliance with all regulations. From sample tracking to accurate documentation, training to methods validation, maintenance to calibration, and out-of-spec responses to preparation for audits, a combination of people, instrumentation and documentation must work in sync for high quality results. This handbook provides information that will help a laboratory achieve high quality results and compliance. Contents: Quality Assurance in the Laboratory, History of Regulation, Training in the Laboratory, Laboratory Documentation and Data, Sample Control and LIM Systems, Methods Validation

Author: Anton Bespalov
Publisher: Springer Nature
ISBN: 3030336565
Category : Cardiology
Languages : en
Pages : 424

View

Book Description
This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.

Author: Philip Carson
Publisher: Royal Society of Chemistry
ISBN: 1847557724
Category : Science
Languages : en
Pages : 657

View

Book Description
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.