Laboratory Control System Operations in a GMP Environment

Develop an understanding of FDA and global regulatory agency requirements for Laboratory Control System (LCS) operations In Laboratory Control System Operations in a GMP Environment, readers are given the guidance they need to implement a CGMP compliant Laboratory Control System (LCS) that fits within Global Regulatory guidelines. Using the Quality Systems Approach, regulatory agencies like the FDA and the European Medicine Agency have developed a scheme of systems for auditing pharmaceutical manufacturing facilities which includes evaluating the LCS. In this guide, readers learn the fundamental rules for operating a CGMP compliant Laboratory Control System. Designed to help leaders meet regulatory standards and operate more efficiently, the text includes chapters that cover Laboratory Equipment Qualification and Calibration, Laboratory Facilities, Method Validation and Method Transfer, Laboratory Computer Systems, Laboratory Investigations as well as Data Governance and Data Integrity. The text also includes chapters related to Laboratory Managerial and Administrative Systems, Laboratory Documentation Practices and Standard Operating Procedures and General Laboratory Compliance Practices.  Additionally, a chapter outlining Stability Program operations is included in the text. In addition to these topics, it includes LCS information and tools such as: ●      End of chapter templates, checklists, and LCS guidance to help you follow the required standards ●      Electronic versions of each tool so users can use them outside of the text ●      An In-depth understanding of what is required by the FDA and other globally significant regulatory authorities for GMP compliant systems For quality assurance professionals working within the pharmaceutical or biopharma industries, this text provides the insight and tools necessary to implement government-defined regulations.

Table of Contents:
Preface xi About the Companion Website xvii 1 Introduction to the Quality Systems Based Approach to CGMP Compliance 1 Overview of Quality Systems and the Laboratory Control System 1 Regulations and Regulatory Bodies 4 Regulatory Guidance 4 Application of This Text 5 Overlap and Redundancy 6 Tools and Templates 6 References 7 2 Components of the Laboratory Managerial and Administrative Systems Sub Element (MS) 9 Description of the Laboratory Managerial and Administrative Systems Sub Element 9 Contents of the Sub Element 10 Tools and Templates 23 Reference 23 3 Components of the Laboratory Documentation Practices and Standard Operating Procedures Sub Element (OP) 25 Description of the Laboratory Documentation Practices and Standard Operating Procedures Sub Element 25 Contents of the Sub Element 26 Tools and Templates 44 4 Components of the Laboratory Equipment Sub Element (LE) 45 Description of the Laboratory Equipment Sub Element 45 Contents of the Sub Element 46 Tools and Templates 68 References 68 5 Components of the Laboratory Facilities Sub Element (LF) 71 Description of the Laboratory Facilities Sub Element 71 Contents of the Sub Element 71 Tools and Templates 81 References 81 6 Components of the Method Validation and Method Transfer Sub Element (MV) 83 Description of the Method Validation and Method Transfer Sub Element 83 Contents of the Sub Element 84 Tools and Templates 93 Glossary 93 References 113 7 Components of the Laboratory Computer Systems Sub Element (LC) 115 Description of the Laboratory Computer Systems Sub Element 115 Contents of the Sub Element 116 Tools and Templates 129 Glossary 130 References 133 8 Components of the Laboratory Investigations Sub Element (LI) 135 Background and Regulatory History of Out-of-Specification Investigations 135 Description of the Laboratory Investigations Sub Element 135 Contents of the Sub Element 139 Common Problems Related to Laboratory OOS Investigations 148 Tools and Templates 149 Glossary 150 References 155 9 Components of the Laboratory Data Governance and Data Integrity Sub Element (DI) 157 Background 157 Precepts Regarding Data Governance and Data Integrity 159 Description of the Laboratory Data Governance and Data Integrity Sub Element 162 Contents of the Sub Element 164 Policy for Data Governance 164 Procedural Controls 165 Technical Controls 166 Data Maps and Data Walks 166 Risk Identification, Ranking, and Filtering 171 Data Reviews 196 Data and Operational Audits 196 Employee Awareness and Training 208 Management Oversight 210 Tools and Templates 212 Glossary 212 References 214 Further Reading 215 10 Components of the Stability Program Sub Element (SB) 217 Description of the Stability Program Sub Element 217 Contents of the Sub Element 218 Model Standard Operating Procedures for Establishing and Maintaining a Stability Program 218 Stability Chambers 246 Tools and Templates 261 Glossary 262 References 268 11 Components of the General Laboratory Compliance Practices Sub Element (CP) 269 Description of the General Laboratory Compliance Practices Sub Element 269 Contents of the Sub Element 270 Tools and Templates 284 12 Summary for Establishing and Maintaining a Laboratory Control System 285 A Brief Review of the Laboratory Control System and Its Sub Elements 285 How Things Can Go Wrong: Examples of Some Regulatory Citations Organized by Sub Element 285 Some Final Thoughts on Establishing and Maintaining a Compliance Laboratory Control System 296 Index 297

About the Author :
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.