This guide is designed to provide laboratory personnel with a step-by-step, hands-on audit system that can be relied on to assure that 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 reader develop new audit systems or upgrade existing ones, with the following objectives: Improve current compliance, demonstrate sustainable compliance, produce data for federal inspections, and avoid regulatory action. The book is accompanied by a CD-ROM which includes templates, checklists, and other valuable tools.

From the Preface: “...The FDA mandates that a drug firm and its laboratory be operated in a state of control by employing conditions and practices that assure compliance with the intent of the Federal Food, Drug, and Cosmetic Act and portions of the CGMP [Current Good Manufacturing Practice] regulations that pertain to it. Specifically, a laboratory, which is in a state of control, provides services that confirm the company is producing finished drug products of sufficient quality, known strength, proper identity, and known purity..."

Target Audience: All personnel working in laboratories regulated by the government, especially facilities operating under CGMPs, CGLPs, and ISO 9000 standards.

Table of Contents:

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

A Summary for Establishing a CGMP Laboratory Audit System

Appendix I: Example Audit Checklists — Laboratory Sub-elements

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