GLP Quality Audit Manual

by Milton A. Anderson

Overview

Designed to enable readers to plan and execute their own audits, this comprehensive guide presents both discussions and practical applications related to establishing a GLP QA unit and performing effective GLP audits. The first section provides the foundation of information needed for designing and initiating a Good Laboratory Practice quality assurance program. Section II contains ready-to-use audit checklists and regulatory references that are in accordance with the most recent regulations. Section III illustrates with examples the document requirements of the Quality Assurance Unit and provides a clear understanding of its function. Section IV comprises the full texts of the relevant standards and regulations along with the Principles of Good Laboratory Practice.

Product Details

ISBN-13:	9780367398439
Publisher:	Taylor & Francis
Publication date:	05/27/2020
Edition description:	3rd ed.
Pages:	464
Product dimensions:	8.62(w) x 10.88(h) x (d)

About the Author

Anderson, Milton A.

Table of Contents

SECTION I: GOOD LABORATORY PRACTICES: Development of Regulations & Guidelines. The QA Unit. Quality Inspections & Audits. Contract Audits. System Audits. Internet Resources. Understanding GLP. SECTION II: QA CHECKLISTS: GLP Audit Checklist, Complete. Abbreviated GLP Audit Checklists. SECTION III: DOCUMENT/REPORT EXAMPLES: Quality Assurance Documents. Inspection Report Examples. SECTION IV: REFERENCES/REGULATORY TEXTS.

Editorial Reviews

New edition of a manual on quality audits in the chemical and healthcare industries. Section I (good laboratory practices) presents background information as well as a foundation for designing and initiating a quality assurance program. Section II (quality audit checklists) offers two types of checklists<-->the complete questionnaire addressing all the relevant regulatory requirements, and the abbreviated, condense form covering preplacement audit and specific phases in auditing. Section III (appendixes) illustrates some basic document requirements. Section IV (regulatory texts) provides several helpful texts, including both the FDA regulations and OECD principles of good laboratory practice. Three-ring binder format. Annotation c. Book News, Inc., Portland, OR (booknews.com)

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