Establishing A CGMP Laboratory Audit System: A Practical Guide / Edition 1 available in Hardcover
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The first systematic, hands-on auditing guide for today'spharmaceutical laboratoriesIn today's litigious environment, pharmaceutical laboratories aresubject to ever stricter operational guidelines as mandated by theFDA, and must be able to establish and demonstrate sustainableoperational practices that ensure compliance with the current goodmanufacturing practice (CGMP) regulations. David Bliesner'sEstablishing a CGMP Laboratory Audit System: A Practical Guide isdesigned to provide laboratory supervisors and personnel with astep-by-step, hands-on audit system that they can rely on to ensuretheir facility remains compliant with all current and futurerequirements. Focusing on a "team approach," the author usesdetailed flowcharts, checklists, and descriptions of the auditingprocess to help readers develop a new audit system or upgrade theircurrent system in order to:* Improve current compliance* Demonstrate sustainable compliance* Produce data for federal inspections* Avoid regulatory actionEnhanced with detailed checklists and a wealth of practical andflexible auditing tools on CD-ROM, this book provides an idealresource for new and future laboratory personnel, and an excellentmeans for keeping existing industry practitioners up to date on thenuances of operating a consistently compliant pharmaceuticallaboratory.
|Product dimensions:||6.30(w) x 9.50(h) x 0.73(d)|
About the Author
DAVID M. BLIESNER, PhD, is the founder and President ofDelphi Analytical Services, Inc., in Indian Rocks Beach, Florida, acompany offering training, training technology, and complianceproducts and services to the pharmaceutical, biopharmaceutical,medical device, and contract analytical laboratory industries. Dr.Bliesner also conducts lectures, short courses, and hands-ontraining relating to technical aspects of the analytical laboratoryand compliance with CGMPs and Good Laboratory Practices (GLPs).
Table of Contents
1. INTRODUCTION TO THE QUALITY SYSTEMS APPROACH TO CGMPCOMPLIANCE.
1.1 Overview of Quality Systems.
1.2 Quality Systems and Compliance with CGMPs: Reasons forAuditing 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.
2.2 Audit Tools and Templates.
2.2.1 Goals of the Audit.
2.2.2 Review of the Audit Process.
2.2.3 Laboratory Audit Form (LAF) Generation Process.
2.2.4 Subelement Audit Strategy Development.
3. AUDITING AND DATA CAPTURE.
3.1 Additional Audit Preparation.
3.1.1 Data Capture and CGMP Deficiency Documentation.
3.1.2 Use of Random Statistical Sampling to Improve theEfficiency and Overall Audit Quality.
4. ORGANIZING DATA AND REPORTING THE RESULTS.
4.2 Format and Content of the Audit Summary Report.
4.2.4 Report Format.
4.2.5 Summary of Results.
4.2.6 Future Work.
4.2.7 Laboratory Controls Subelement Sections.
5. DEVELOPING AND IMPLEMENTING A CORRECTIVE ACTIONPLAN.
5.2 LAF-to-CAPA Workflow Diagram: Converting Example AuditFindings to Example Corrective and Preventive Actions.
5.2.1 Step 1 Audit Finding Notebook Entries.
5.2.2 Step 2 Formal Documentation of Finding or Deficiency onLAFs.
5.2.3 Step 3 Common Root-Cause Correlation by Management.
5.2.4 Step 4 LAF Linkage to System Deficiencies.
5.2.5 Step 5 Management Assignment of Corrective Actions toAddress System Deficiency.
5.2.6 Step 6 Work Breakdown Structure (WBS) Is Generated.
5.2.7 Step 7 Corrective Action Project Plan (CAPP) Created FromWBS and Executed.
5.2.8 Step 8 Corrective and Preventive Actions (CAPAs) forSystem Deficiencies.
6. DEVELOPING AND IMPLEMENTING A VERIFICATION PLAN.
6.2 Corrective Action Verification Process.
6.2.1 Step 1 Action Owners Work with Corrective Action Team toDesign and Implement Systems-Based Corrective Actions.
6.2.2 Step 2 Corrective and Preventive Actions AreImplemented.
6.2.3 Step 3 In-Use Data for Implemented Corrective andPreventive Actions Are Generated.
6.2.4 Step 4 Action Owners Working with Corrective Action TeamCreate Preverification Packages for Verifiers.
6.2.5 Step 5 Verification Team Leader Schedules Verificationwith Verifiers, Action Owners, and Functional Area Managers.
6.2.6 Step 6 Verifiers Review Preverification Packages.
6.2.7 Step 7 Verifiers Generate Verification Plans.
6.2.8 Step 8 Verifiers Meet with Action Owners as Scheduled byCorrective Action Team Leader.
6.2.9 Step 9 Verifiers Begin Verifying Corrective and PreventiveActions in the Functional Area.
6.2.10 Step 10 Verifiers Determine Whether Action Is Verifiableor Not Verifiable.
6.2.11 Step 11 Verifiers Create Verification Report.
6.2.12 Step 12 Verification Team Leader Schedules Verifiers toPresent Findings Before the Verification Review Board.
6.2.13 Step 13 Verifier Forwards Verification Report toVerification Review Board for Review.
6.2.14 Step 14 Verifier Presents Report to Verification ReviewBoard.
6.2.15 Step 15 Verification Board Determines if the Action Is(1) Verifiable, (2) Not Verifiable or, (3) Verifiable PendingIn-Use Data.
6.2.16 Step 16 Verifier Modifies or Corrects Verification Reportas Necessary on Verifiable Actions.
6.2.17 Step 17 Verifiable Actions are Closed by Action Owner,Corrective Action Team Leader, and Verification Team Leader.
6.2.18 Step 18 Nonverifiable Actions Are Sent Back to ActionOwner for Additional Work.
6.2.19 Step 19 Verifiers Reverify Uncompleted Actions WhenScheduled by Verification Team Leader.
7. DEVELOPING AND IMPLEMENTING A MONITORING PLAN.
8. A SUMMARY FOR ESTABLISHING A CGMP LABORATORY AUDITSYSTEM.
8.1 A Brief Review of the Guide.
8.2 Additional Lessons for the End User.
8.2.1 A Proven Approach.
8.2.2 Applicability to Your Facility.
8.2.3 The Value of Systems-Based Solutions.
8.2.4 No Immunity: Every Laboratory Is a Potential ComplianceAccident in the Making.
8.2.5 Audits as Learning Tools.
8.2.6 The Linkage Between Ownership and Success.
8.2.7 Compliance Is Good Business.
APPENDIX I. EXAMPLE AUDIT CHECKLISTS: LABORATORYSUBELEMENTS.
APPENDIX II. EXAMPLE TEMPLATE FOR AN AUDIT SUMMARYREPORT.
APPENDIX III. GLOSSARY OF CGMP AND AUDIT SYSTEMTERMS.
APPENDIX IV. FDA COMPLIANCE PROGRAM GUIDANCE MANUAL7356.002 "DRUG MANUFACTURING INSPECTIONS".
APPENDIX V. 21 CODE OF U.S. FEDERAL REGULATIONS PARTS 210 AND211 CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS.