Laboratory Control System Operations in a GMP Environment

ISBN-13: 9781119529231 / Angielski / Twarda / 2020 / 320 str.

David M. Bliesner

Spis treści

Preface xiAbout the Companion Website xvii1 Introduction to the Quality Systems Based Approach to CGMP Compliance 1Overview of Quality Systems and the Laboratory Control System 1Regulations and Regulatory Bodies 4Regulatory Guidance 4Application of This Text 5Overlap and Redundancy 6Tools and Templates 6References 72 Components of the Laboratory Managerial and Administrative Systems Sub Element (MS) 9Description of the Laboratory Managerial and Administrative Systems Sub Element 9Contents of the Sub Element 10Tools and Templates 23Reference 233 Components of the Laboratory Documentation Practices and Standard Operating Procedures Sub Element (OP) 25Description of the Laboratory Documentation Practices and Standard Operating Procedures Sub Element 25Contents of the Sub Element 26Tools and Templates 444 Components of the Laboratory Equipment Sub Element (LE) 45Description of the Laboratory Equipment Sub Element 45Contents of the Sub Element 46Tools and Templates 68References 685 Components of the Laboratory Facilities Sub Element (LF) 71Description of the Laboratory Facilities Sub Element 71Contents of the Sub Element 71Tools and Templates 81References 816 Components of the Method Validation and Method Transfer Sub Element (MV) 83Description of the Method Validation and Method Transfer Sub Element 83Contents of the Sub Element 84Tools and Templates 93Glossary 93References 1137 Components of the Laboratory Computer Systems Sub Element (LC) 115Description of the Laboratory Computer Systems Sub Element 115Contents of the Sub Element 116Tools and Templates 129Glossary 130References 1338 Components of the Laboratory Investigations Sub Element (LI) 135Background and Regulatory History of Out-of-Specification Investigations 135Description of the Laboratory Investigations Sub Element 135Contents of the Sub Element 139Common Problems Related to Laboratory OOS Investigations 148Tools and Templates 149Glossary 150References 1559 Components of the Laboratory Data Governance and Data Integrity Sub Element (DI) 157Background 157Precepts Regarding Data Governance and Data Integrity 159Description of the Laboratory Data Governance and Data Integrity Sub Element 162Contents of the Sub Element 164Policy for Data Governance 164Procedural Controls 165Technical Controls 166Data Maps and Data Walks 166Risk Identification, Ranking, and Filtering 171Data Reviews 196Data and Operational Audits 196Employee Awareness and Training 208Management Oversight 210Tools and Templates 212Glossary 212References 214Further Reading 21510 Components of the Stability Program Sub Element (SB) 217Description of the Stability Program Sub Element 217Contents of the Sub Element 218Model Standard Operating Procedures for Establishing and Maintaining a Stability Program 218Stability Chambers 246Tools and Templates 261Glossary 262References 26811 Components of the General Laboratory Compliance Practices Sub Element (CP) 269Description of the General Laboratory Compliance Practices Sub Element 269Contents of the Sub Element 270Tools and Templates 28412 Summary for Establishing and Maintaining a Laboratory Control System 285A Brief Review of the Laboratory Control System and Its Sub Elements 285How Things Can Go Wrong: Examples of Some Regulatory Citations Organized by Sub Element 285Some Final Thoughts on Establishing and Maintaining a Compliance Laboratory Control System 296Index 297

O autorze

DAVID M. BLIESNER, Ph.D., is Founder and President of Delphi Analytical Services, Inc. He provides CGMP consulting and training services to the pharmaceutical, biopharmaceutical, contract analytical laboratory, and allied industries. He possesses a unique combination of science and business skills and experience. These skills and experiences range from analytical R&D in the pharmaceutical industry to business plan preparation and market analysis in the chromatography supplies and contract analytical and instrument services businesses. Dr. Bliesner' s expertise includes quality assurance auditing of GMP laboratories, developing and implementing corrective action plans for analytical laboratories with compliance challenges, high performance liquid chromatography, experimental protocol design and project management. He has been part of the "Expert Consultant" contingent for five companies operating under consent decree with the FDA where he has helped with the establishment of GMP compliant laboratory control systems.