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.

Features:

• 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

Contents

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

Index

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