2185good Automated Laboratory Practices Principles And Guidance To Regulations For Ensuring Data Integrity In Automated Laboratory Operations With Implementation Guidance

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

Good Automated Laboratory Practices Principles And Guidance To Regulations For Ensuring Data Integrity In Automated Laboratory Operations With Implementation Guidance 1995 Edition

A complete guide to regulatory compliance monitoring using atomic spectrometry This is the only comprehensive, single-volume guide to all methods of atomic spectrometry currently recognized by regulatory agencies for the monitoring of metallic contaminants. It is an indispensable working resource for analytical chemists and spectroscopists responsible for generating scientifically and legally defensible laboratory results for regulatory compliance. The book answers virtually every question regarding material selection, preparation, preservation, analysis, and the testing equipment itself. It begins with a thorough explication of the three major spectrometric methods: atomic absorption, inductively coupled plasma atomic spectrometry, and inductively coupled plasma mass spectrometry. Each method is described in terms of its scope of sensitivity, theoretical principles, material and equipment requirements, interferences and their corrections, and calibration. Following chapters provide detailed accounts of sample collection, preservation, and preparation; concentration and separation methods; and laboratory analysis methods for compliance monitoring of air, water, wastes, animal tissues, and food. The authors also provide helpful hints and guidelines on how to organize a laboratory; plan projects; report results; communicate with clients, regulators, and the public; market services; and more.

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.

Gillespie includes all the necessary procedures for documenting and implementing the process, detailed information on preparing for registration and audit, case studies, and interviews with executives in industry.