[eBook Code] Laboratory Control System Operations in a GMP Environment (eBook Code, 1st)

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