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  • Academic Resource Center Mahasarakham University

Laboratory Control System Operations in a GMP Environment

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

ใส่ตะกร้า
  • ISBN9781119529231
  • ประเภท E-Book
  • ผู้แต่ง David M. Bliesner
  • สำนักพิมพ์ Wiley
  • ครั้งที่พิมพ์ 1
  • ปีที่พิมพ์2020
  • ภาษาภาษาอังกฤษ
  • หมวดหมู่สิ่งแวดล้อม
: ข้อมูลหนังสือ

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