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Establishing a CGMP Laboratory Audit System
A Practical Guide
by David M. Bliesner

Establishing a CGMP Laboratory Audit System 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.


  • Uses detailed flowcharts, checklists, and descriptions of the auditing process to help readers develop a new audit system or upgrade their current system
  • Includes detailed checklists and a wealth of practical and flexible auditing tools on CD-ROM
  • 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


The Quality Systems Approach to CGMP Compliance

  • Overview of Quality Systems.
  • Quality Systems and Compliance with CGMPs: Reasons for Auditing Your Laboratory.
  • Goals of Auditing Your Laboratory.
  • Laboratory Audit Phases.
  • Integration with Existing Programs.
  • Modifiable and Scalable Approach

Preparing for the Audit

  • Procedure.
  • Audit Tools and Templates.
  • Goals of the Audit.
  • Review of the Audit Process.
  • Laboratory Audit Form (LAF) Generation Process.
  • Subelement Audit Strategy Development

Auditing and Data Capture

  • Additional Audit Preparation.
  • Data Capture and CGMP Deficiency Documentation.
  • Use of Random Statistical Sampling to Improve the Efficiency and Overall Audit Quality.
  • Procedure

Organizing Data and Reporting the Results

  • Procedure.
  • Format and Content of the Audit Summary Report.
  • Header.
  • Background.
  • Approach.
  • Report Format.
  • Summary of Results.
  • Future Work.
  • Laboratory Controls Subelement Sections

Developing and Implementing a Corrective Action Plan

  • Procedure.
  • LAF-to-CAPA Workflow Diagram: Converting Example Audit Findings to Example Corrective and Preventive Actions.
  • Step 1 Audit Finding Notebook Entries.
  • Step 2 Formal Documentation of Finding or Deficiency on LAFs.
  • Step 3 Common Root-Cause Correlation by Management.
  • Step 4 LAF Linkage to System Deficiencies.
  • Step 5 Management Assignment of Corrective Actions to Address System Deficiency.
  • Step 6 Work Breakdown Structure (WBS) Is Generated.
  • Step 7 Corrective Action Project Plan (CAPP) Created From WBS and Executed.
  • Step 8 Corrective and Preventive Actions (CAPAs) for System Deficiencies

Developing and Implementing a Verification Plan

  • Procedure.
  • Corrective Action Verification Process.
  • Step 1 Action Owners Work with Corrective Action Team to Design and Implement Systems-Based Corrective Actions.
  • Step 2 Corrective and Preventive Actions Are Implemented.
  • Step 3 In-Use Data for Implemented Corrective and Preventive Actions Are Generated.
  • Step 4 Action Owners Working with Corrective Action Team Create Preverification Packages for Verifiers.
  • Step 5 Verification Team Leader Schedules Verification with Verifiers, Action Owners, and Functional Area Managers.
  • Step 6 Verifiers Review Preverification Packages.
  • Step 7 Verifiers Generate Verification Plans.
  • Step 8 Verifiers Meet with Action Owners as Scheduled by Corrective Action Team Leader.
  • Step 9 Verifiers Begin Verifying Corrective and Preventive Actions in the Functional Area.
  • Step 10 Verifiers Determine Whether Action Is Verifiable or Not Verifiable.
  • Step 11 Verifiers Create Verification Report.
  • Step 12 Verification Team Leader Schedules Verifiers to Present Findings Before the Verification Review Board.
  • Step 13 Verifier Forwards Verification Report to Verification Review Board for Review.
  • Step 14 Verifier Presents Report to Verification Review Board.
  • Step 15 Verification Board Determines if the Action Is (1) Verifiable, (2) Not Verifiable or, (3) Verifiable Pending In-Use Data.
  • Step 16 Verifier Modifies or Corrects Verification Report as Necessary on Verifiable Actions.
  • Step 17 Verifiable Actions are Closed by Action Owner, Corrective Action Team Leader, and Verification Team Leader.
  • Step 18 Nonverifiable Actions Are Sent Back to Action Owner for Additional Work.
  • Step 19 Verifiers Reverify Uncompleted Actions When Scheduled by Verification Team Leader

Developing and Implementing a Monitoring Plan

  • Procedure

A Summary for Establishing a CGMP Laboratory Audit System

  • A Brief Review of the Guide.
  • Additional Lessons for the End User.
  • A Proven Approach.
  • Applicability to Your Facility.
  • The Value of Systems-Based Solutions.
  • No Immunity: Every Laboratory Is a Potential Compliance Accident in the Making.
  • Audits as Learning Tools.
  • The Linkage Between Ownership and Success.
  • Compliance Is Good Business


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Establishing a CGMP Laboratory Audit System
A Practical Guide
by David M. Bliesner

2006 • 277 pages • $104.00 + shipping
Texas residents please add 6.75 % sales tax

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