GLP Quality Audit Manual: 3rd Edition (Hardback) book cover

GLP Quality Audit Manual

3rd Edition

By Milton A. Anderson

CRC Press

436 pages

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Hardback: 9781574911060
pub: 2000-06-22
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Description

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.

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

include the US FDA Good Laboratory Practice Regulations and the OECD Principles of Good Laboratory Practice.

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology