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
- 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.
Organizing Data and Reporting the Results
- Format and Content of the Audit Summary Report.
- Report Format.
- Summary of Results.
- Future Work.
- Laboratory Controls Subelement Sections
Developing and Implementing a Corrective Action Plan
- 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
- 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
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