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.

List 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
 
Descriptio

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.

Summary

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.

Product details

• Authors: Bliesner, David M Bliesner, David M. Bliesner, David M. (Delphi Analytical Services Bliesner, DM Bliesner, Bliesner David M.
• Publisher: Wiley, John and Sons Ltd
• Languages: English
• Product format: Hardback
• Released: 31.05.2020
• EAN: 9781119529231
• ISBN: 978-1-119-52923-1
• No. of pages: 320
• Subjects: Natural sciences, medicine, IT, technology > Chemistry > Theoretical chemistry; Chemie, Arbeitssicherheit, Qualitätssicherung, Prozesssteuerung, chemistry, Quality assurance, Chemical Engineering, chemische Verfahrenstechnik, Chemical and Environmental Health and Safety, Arbeitssicherheit u. Umweltschutz i. d. Chemie, Qualitätssicherung in der Chemie, Process Engineering