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Informationen zum Autor 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). Klappentext The first systematic, hands-on auditing guide for today's pharmaceutical laboratoriesIn 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 actionEnhanced 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. Zusammenfassung Establishing a CGMP Laboratory Audit System: A Practical Guide guides the reader through establishing a Current Good Manufacturing Practices laboratory audit system using detailed flowcharts, checklists, and descriptions of the process. Templates and checklists on a CD-ROM provide for easy use and modification in the laboratory. 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 ...
