Laboratory Control System Operations in a GMP Environment - by David M Bliesner (Hardcover)

About the Book

"This book provides the basis for operating a CGMP compliant Laboratory Control System (LCS) implemented in QC and R&D laboratories. Improving an organizations chances for withstanding Regulatory scrutiny and enhancing operational efficiency. The book focuses both on the operational aspects of the original seven LCS sub elements, but expands the LCS to encompass three additional sub elements. Resulting in the following chapters in the book: Laboratory Managerial and Administrative Systems; Laboratory Documentation Practices and Standard Operating Procedures; Laboratory Equipment Qualification and Calibration; Laboratory Facilities; Methods Validation and Technology Transfer; Laboratory Computer Systems; Laboratory Investigations; Data Governance and Data Integrity; Stability Program; and General Laboratory Compliance Practices. 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. In addition, each chapter includes link to tools, templates, checklists and Global Regulatory Agencies' guidance. All of these tools and templates will be provided electronically for easy application by the end-user in their own laboratories. It is the inclusion of these practical tools that makes this text unique. It would require untold man hours if one were to develop these checklists and example-templates on one's own"--

Book Synopsis

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.

From the Back Cover

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, 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.

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.