Establishing A CGMP Laboratory Audit System: A Practical Guide

David M. Bliesner

ISBN: 9788126577576




The Food and Drug Administration mandates that a pharmaceutical laboratory be operated in a state of control by employing conditions and practices that ensure compliance with the Federal Food, Drug, and Cosmetic Act and portions of the Current Good Manufacturing Processes (CGMPs) relating to it.  A laboratory in this state of control provides services that confirm that the company as a whole is producing finished drug products of known quality, strength, identity, and purity. The data used to demonstrate this state of control are obtained via a systematic laboratory audit.




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.


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.