John Wiley & Sons Laboratory Control System Operations in a GMP Environment Cover The book allows readers to fully implement a functional Laboratory Control System (LCS) which can wi.. Product #: 978-1-119-52923-1 Regular price: $132.38 $132.38 Auf Lager

Laboratory Control System Operations in a GMP Environment

Bliesner, David M.

Cover

1. Auflage Juni 2020
320 Seiten, Hardcover
Wiley & Sons Ltd

ISBN: 978-1-119-52923-1
John Wiley & Sons

Kurzbeschreibung

The book allows readers to fully implement a functional Laboratory Control System (LCS) which can withstand Global Regulatory scrutiny. 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. Each chapter includes link to tools, templates, checklists and Global Regulatory Agencies' guidance.

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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.

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
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.

D. M. Bliesner, Delphi Analytical Services, Inc., Indian Rocks Beach, Florida.