Establishing a CGMP laboratory audit system

a practical guide

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Last edited by MARC Bot
December 11, 2020 | History

Establishing a CGMP laboratory audit system

a practical guide

  • 1 Want to read

The first systematic, hands-on auditing guide for today's pharmaceutical laboratories In today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing a CGMP Laboratory Audit System: A Practical Guide is designed to provide laboratory supervisors and personnel with a step-by-step, hands-on audit system that they can rely on to ensure their facility remains compliant with all current and future requirements. Focusing on a "team approach," the author uses detailed flowcharts, checklists, and descriptions of the auditing process to help readers develop a new audit system or upgrade their current system in order to: Improve current compliance Demonstrate sustainable compliance Produce data for federal inspections Avoid regulatory action Enhanced with detailed checklists and a wealth of practical and flexible auditing tools on CD-ROM, this book provides an ideal resource for new and future laboratory personnel, and an excellent means for keeping existing industry practitioners up to date on the nuances of operating a consistently compliant pharmaceutical laboratory.Note: CD-ROM/DVD and other supplementary materials are not included.

Publish Date
Publisher
Wiley-Interscience
Language
English

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Previews available in: English

Edition Availability
Cover of: Establishing a CGMP Laboratory Audit System
Establishing a CGMP Laboratory Audit System: A Practical Guide
2007, Wiley & Sons, Incorporated, John
in English
Cover of: Establishing a Cgmp Laboratory Audit System
Establishing a Cgmp Laboratory Audit System
2006, Wiley & Sons Canada, Limited, John
in English
Cover of: Establishing a CGMP Laboratory Audit System
Establishing a CGMP Laboratory Audit System: A Practical Guide
2006, Wiley & Sons, Incorporated, John
in English
Cover of: Establishing a CGMP laboratory audit system
Establishing a CGMP laboratory audit system: a practical guide
2006, Wiley-Interscience
in English
Cover of: Establishing A CGMP Laboratory Audit System
Establishing A CGMP Laboratory Audit System
2006, John Wiley & Sons, Ltd.
Electronic resource in English

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Book Details


Table of Contents

Preface
Introduction to the quality systems approach to CGMP compliance
Preparing for the audit
Auditing and data capture
Organizing data and reporting the results
Developing and implementing a corrective action plan
Developing and implementing a verification plan
Developing and implementing a monitoring plan
Summary
Appendixes
Example audit checklists: laboratory sub elements
Audit summary report example-template
Glossary of CGMP and audit system terms
Food and drug administration compliance program: guidance manual 7356.002 "drug manufacturing inspections"
21 Code of Federal Regulations parts 210 and 211: 487 current good manufacturing practice regulations.

Edition Notes

Includes bibliographical references and index.

Published in
Hoboken, N.J

Classifications

Dewey Decimal Class
343.7307/86151
Library of Congress
KF1879 .B55 2006, KF1879.B55 2006

The Physical Object

Pagination
p. cm.

ID Numbers

Open Library
OL3408304M
Internet Archive
establishingcgmp00blie
ISBN 10
0471738409
LCCN
2005024178
Library Thing
7058091
Goodreads
3541634

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December 11, 2020 Edited by MARC Bot import existing book
August 20, 2020 Edited by ImportBot import existing book
July 22, 2019 Edited by MARC Bot remove fake subjects
July 29, 2014 Edited by ImportBot import new book
December 10, 2009 Created by WorkBot add works page