CGMP Laboratory Audit System

1. Auflage 2006
ISBN: 978-0-471-73840-4
Verlag: John Wiley & Sons

Buch, Englisch, 304 Seiten, Book with CD-ROM, Format (B × H): 161 mm x 240 mm, Gewicht: 610 g

The first systematic, hands-on auditing guide for today's pharmaceutical laboratories

In today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing a CGMP Laboratory Audit System: A Practical Guide 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. Focusing on a "team approach," the author uses detailed flowcharts, checklists, and descriptions of the auditing process to help readers develop a new audit system or upgrade their current system in order to:

* Improve current compliance
* Demonstrate sustainable compliance
* Produce data for federal inspections
* Avoid regulatory action

Enhanced with detailed checklists and a wealth of practical and flexible auditing tools on CD-ROM, this book 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.

Autoren/Hrsg.

Bliesner, David M.

Fachgebiete

• Naturwissenschaften Chemie Chemie Allgemein Toxikologie, Gefahrstoffe, Sicherheit in der Chemie
• Naturwissenschaften Chemie Chemie Allgemein Chemometrik, Chemoinformatik
• Naturwissenschaften Chemie Chemie Allgemein Chemische Labormethoden, Stöchiometrie
• Technische Wissenschaften Technik Allgemein Modellierung & Simulation
• Naturwissenschaften Physik Physik Allgemein Experimentalphysik
• Interdisziplinäres Wissenschaften Wissenschaften: Forschung und Information Forschungsmethodik, Wissenschaftliche Ausstattung
• Naturwissenschaften Chemie Chemie Allgemein Pharmazeutische Chemie, Medizinische Chemie

Inhaltsverzeichnis

Preface xiii

1 Introduction to the Quality Systems Approach to Cgmp Compliance 1
1.1 Overview of Quality Systems 1
1.2 Quality Systems and Compliance with CGMPs: Reasons for Auditing Your Laboratory 3
1.3 Goals of Auditing Your Laboratory 3
1.4 Laboratory Audit Phases 4
1.5 Integration with Existing Programs 4
1.6 Modifiable and Scalable Approach 4
Reference 5
Bibliography 5

2 Preparing for the Audit 6
2.1 Procedure 6
2.2 Audit Tools and Templates 6
2.2.1 Goals of the Audit 14
2.2.2 Review of the Audit Process 14
2.2.3 Laboratory Audit Form (LAF) Generation Process 20
2.2.4 Subelement Audit Strategy Development 20

3 Auditing and Data Capture 27
3.1 Additional Audit Preparation 27
3.1.1 Data Capture and CGMP Deficiency Documentation 27
3.1.2 Use of Random Statistical Sampling to Improve the Efficiency and Overall Audit Quality 34
3.2 Procedure 39

4 Organizing Data and Reporting the Results 45
4.1 Procedure 45
4.2 Format and Content of the Audit Summary Report 48
4.2.1 Header 48
4.2.2 Background 49
4.2.3 Approach 49
4.2.4 Report Format 49
4.2.5 Summary of Results 50
4.2.6 Future Work 51
4.2.7 Laboratory Controls Subelement Sections 52

5 Developing and Implementing a Corrective Action Plan 53
5.1 Procedure 53
5.2 LAF-to-CAPA Workflow Diagram: Converting Example Audit Findings to Example Corrective and Preventive Actions 66
5.2.1 Step 1 Audit Finding Notebook Entries 66
5.2.2 Step 2 Formal Documentation of Finding or Deficiency on LAFs 66
5.2.3 Step 3 Common Root-Cause Correlation by Management 67
5.2.4 Step 4 LAF Linkage to System Deficiencies 67
5.2.5 Step 5 Management Assignment of Corrective Actions to Address System Deficiency 67
5.2.6 Step 6 Work Breakdown Structure (WBS) Is Generated 68
5.2.7 Step 7 Corrective Action Project Plan (CAPP) Created From WBS and Executed 68
5.2.8 Step 8 Corrective and Preventive Actions (CAPAs) for System Deficiencies 68

6 Developing and Implementing a Verification Plan 69
6.1 Procedure 69
6.2 Corrective Action Verification Process 69
6.2.1 Step 1 Action Owners Work with Corrective Action Team to Design and Implement Systems-Based Corrective Actions 75
6.2.2 Step 2 Corrective and Preventive Actions Are Implemented 77
6.2.3 Step 3 In-Use Data for Implemented Corrective and Preventive Actions Are Generated 77
6.2.4 Step 4 Action Owners Working with Corrective Action Team Create Preverification Packages for Verifiers 77
6.2.5 Step 5 Verification Team Leader Schedules Verification with Verifiers, Action Owners, and Functional Area Managers 77
6.2.6 Step 6 Verifiers Review Preverification Packages 78
6.2.7 Step 7 Verifiers Generate Verification Plans 78
6.2.8 Step 8 Verifiers Meet with Action Owners as Scheduled by Corrective Action Team Leader 78
6.2.9 Step 9 Verifiers Begin Verifying Corrective and Preventive Actions in the Functional Area 78
6.2.10 Step 10 Verifiers Determine Whether Action Is Verifiable or Not Verifiable 78
6.2.11 Step 11 Verifiers Create Verification Report 79
6.2.12 Step 12 Verification Team Leader Schedules Verifiers to Present Findings Before the Verification Review Board 82
6.2.13 Step 13 Verifier Forwards Verification Report to Verification Review Board for Review 82
6.2.14 Step 14 Verifier Presents Report to Verification Review Board 82
6.2.15 Step 15 Verification Board Determines if the Action Is (1) Verifiable, (2) Not Verifiable or, (3) Verifiable Pending In-Use Data 82
6.2.16 Step 16 Verifier Modifies or Corrects Verification Report as Necessary on Verifiable Actions 82
6.2.17 Step 17 Verifiable Actions are Closed by Action Owner, Corrective Action Team Leader, and Verification Team Leader 83
6.2.18 Step 18 Nonverifiable Actions Are Sent Back to Action Owner for Additional Work 83
6.2.19 Step 19 Verifiers Reverify Uncompleted Actions When Scheduled by Verification Team Leader 83

7 Developing and Implementing a Monitoring Plan 84
7.1 Procedure 84

8 A Summary for Establishing a Cgmp Laboratory Audit System 89
8.1 A Brief Review of the Guide 89
8.2 Additional Lessons for the End User 90
8.2.1 A Proven Approach 90
8.2.2 Applicability to Your Facility 90
8.2.3 The Value of Systems-Based Solutions 91
8.2.4 No Immunity: Every Laboratory Is a Potential Compliance Accident in the Making 92
8.2.5 Audits as Learning Tools 92
8.2.6 The Linkage Between Ownership and Success 92
8.2.7 Compliance Is Good Business 93

Appendix I Example Audit Checklists: Laboratory Subelements 94
Appendix II Example Template for An Audit Summary Report 146
Appendix III Glossary of Cgmp and Audit System Terms 200
Appendix IV Fda Compliance Program Guidance Manual 7356.002 "drug Manufacturing Inspections" 215
Appendix v 21 Code of U.s. Federal Regulations Parts 210 and 211 Current Good Manufacturing Practice Regulations 236

Index 269

Über Autor(innen)

DAVID M. BLIESNER, PhD, is the founder and President of Delphi Analytical Services, Inc., in Indian Rocks Beach, Florida, a company offering training, training technology, and compliance products and services to the pharmaceutical, biopharmaceutical, medical device, and contract analytical laboratory industries. Dr. Bliesner also conducts lectures, short courses, and hands-on training relating to technical aspects of the analytical laboratory and compliance with CGMPs and Good Laboratory Practices (GLPs).