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
