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.
Produkt-Info
Auflage
Sprache
Verlagsort
Verlagsgruppe
Zielgruppe
Illustrationen
Charts: 17 B&W, 0 Color; Screen captures: 1 B&W, 0 Color; Tables: 33 B&W, 0 Color
Maße
Höhe: 240 mm
Breite: 161 mm
Dicke: 20 mm
Gewicht
ISBN-13
978-0-471-73840-4 (9780471738404)
Schweitzer Klassifikation
DAVID M. BLIESNER, PhD, is the founder and President of Delphi Analytical Services, Inc., in Indian Rocks Beach, Florida, a company offering training, training technology, and compliance products and services to the pharmaceutical, biopharmaceutical, medical device, and contract analytical laboratory industries. Dr. Bliesner also conducts lectures, short courses, and hands-on training relating to technical aspects of the analytical laboratory and compliance with CGMPs and Good Laboratory Practices (GLPs).
PREFACE.
1. INTRODUCTION TO THE QUALITY SYSTEMS APPROACH TO CGMP COMPLIANCE.
1.1 Overview of Quality Systems.
1.2 Quality Systems and Compliance with CGMPs: Reasons for Auditing Your Laboratory.
1.3 Goals of Auditing Your Laboratory.
1.4 Laboratory Audit Phases.
1.5 Integration with Existing Programs.
1.6 Modifiable and Scalable Approach.
Reference.
Bibliography.
2. PREPARING FOR THE AUDIT.
2.1 Procedure.
2.2 Audit Tools and Templates.
3. AUDITING AND DATA CAPTURE.
3.1 Additional Audit Preparation.
3.2 Procedure.
4. ORGANIZING DATA AND REPORTING THE RESULTS.
4.1 Procedure.
4.2 Format and Content of the Audit Summary Report.
5. DEVELOPING AND IMPLEMENTING A CORRECTIVE ACTION PLAN.
5.1 Procedure.
5.2 LAF-to-CAPA Workflow Diagram: Converting Example Audit Findings to Example Corrective and Preventive Actions.
6. DEVELOPING AND IMPLEMENTING A VERIFICATION PLAN.
6.1 Procedure.
6.2 Corrective Action Verification Process.
7. DEVELOPING AND IMPLEMENTING A MONITORING PLAN.
7.1 Procedure.
8. A SUMMARY FOR ESTABLISHING A CGMP LABORATORY AUDIT SYSTEM.
8.1 A Brief Review of the Guide.
8.2 Additional Lessons for the End User.
APPENDIX I. EXAMPLE AUDIT CHECKLISTS: LABORATORY SUBELEMENTS.
APPENDIX II. EXAMPLE TEMPLATE FOR AN AUDIT SUMMARY REPORT.
APPENDIX III. GLOSSARY OF CGMP AND AUDIT SYSTEM TERMS.
APPENDIX IV. FDA COMPLIANCE PROGRAM GUIDANCE MANUAL 7356.002 "DRUG MANUFACTURING INSPECTIONS".
APPENDIX V. 21 CODE OF U.S. FEDERAL REGULATIONS PARTS 210 AND 211 CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS.
INDEX.
