Laboratory control system operations in a GMP environment / David M. Bliesner.

By: Bliesner, David M [author.]
Language: English Publisher: Hoboken, NJ : Wiley, 2020Description: 1 online resourceContent type: text Media type: computer Carrier type: online resourceISBN: 9781119529293; 9781119529279Subject(s): Medical laboratories -- Quality control | Laboratories -- Management | Pharmacy -- Research | Manufacturing processes -- Quality controlGenre/Form: Electronic books.DDC classification: 610.28/4 LOC classification: RB36.3.Q34Online resources: Full text available at Wiley Online Library Click here to view
Contents:
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
Summary: "This book provides the basis for operating a CGMP compliant Laboratory Control System (LCS) implemented in QC and R&D laboratories. Improving an organizations chances for withstanding Regulatory scrutiny and enhancing operational efficiency. The book focuses both on the operational aspects of the original seven LCS sub elements, but expands the LCS to encompass three additional sub elements. Resulting in the following chapters in the book: Laboratory Managerial and Administrative Systems; Laboratory Documentation Practices and Standard Operating Procedures; Laboratory Equipment Qualification and Calibration; Laboratory Facilities; Methods Validation and Technology Transfer; Laboratory Computer Systems; Laboratory Investigations; Data Governance and Data Integrity; Stability Program; and General Laboratory Compliance Practices. Each chapter describes the critical functions of the LCS sub element so the reader understands what is expected from the FDA and Global Regulatory Agencies. In addition, each chapter includes link to tools, templates, checklists and Global Regulatory Agencies' guidance. All of these tools and templates will be provided electronically for easy application by the end-user in their own laboratories. It is the inclusion of these practical tools that makes this text unique. It would require untold man hours if one were to develop these checklists and example-templates on one's own"-- Provided by publisher.
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Includes index.

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.

Includes bibliographical references and index.

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

"This book provides the basis for operating a CGMP compliant Laboratory Control System (LCS) implemented in QC and R&D laboratories. Improving an organizations chances for withstanding Regulatory scrutiny and enhancing operational efficiency. The book focuses both on the operational aspects of the original seven LCS sub elements, but expands the LCS to encompass three additional sub elements. Resulting in the following chapters in the book: Laboratory Managerial and Administrative Systems; Laboratory Documentation Practices and Standard Operating Procedures; Laboratory Equipment Qualification and Calibration; Laboratory Facilities; Methods Validation and Technology Transfer; Laboratory Computer Systems; Laboratory Investigations; Data Governance and Data Integrity; Stability Program; and General Laboratory Compliance Practices. Each chapter describes the critical functions of the LCS sub element so the reader understands what is expected from the FDA and Global Regulatory Agencies. In addition, each chapter includes link to tools, templates, checklists and Global Regulatory Agencies' guidance. All of these tools and templates will be provided electronically for easy application by the end-user in their own laboratories. It is the inclusion of these practical tools that makes this text unique. It would require untold man hours if one were to develop these checklists and example-templates on one's own"-- Provided by publisher.

Description based on print version record.

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