Quality and GMP Auditing: Clear and Simple

by James L. Vesper

Overview

This guidebook provides proven methods and techniques for performing effective audits that serve your department, your company, and you. Topics covered relate to the four key competencies essential for successful GMP audits. Includes the rationale for auditing as an important quality tool, along with the audit cycle, broken into five distinct phase

Product Details

ISBN-13:	9781040204375
Publisher:	CRC Press
Publication date:	07/31/1997
Sold by:	Barnes & Noble
Format:	eBook
Pages:	240
File size:	1 MB

About the Author

James L. Vesper

Table of Contents

What Is a GMP or Quality Audit? Big Picture. Regulatory Requirements & Expectations for GMP Audits. Your Auditing Policy & SOP. Types of Audits. Audit Approaches. Auditor Qualifications & Skills. Phase I: Preparation. Phase II: Conduct the Audit. Interviewing Auditees. Phase III: Analyzing the Audit Data. Phase IV: The Audit Report. Phase V: Follow-up & Closure. Auditing Vendors & Contractors. Being Audited.

Editorial Reviews

A consultant in the pharmaceutical and medical device industries explains to quality professionals the principles of Good Manufacturing Practices auditing and how to apply them to specific companies. He uses a building-block approach to describe the four key competencies essential for successful audits, break the audit cycle down into five distinct phases, and suggest a dozen approaches for different situations. The topics include auditing policy and standard operating practices, types of audits, qualifications and skills, planning and preparing, conducting the audit, analyzing the data, the report, and follow-up and closing. Six professionals in the field also share their experiences and impressions in short questionnaires. Annotation c. by Book News, Inc., Portland, Or.

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