Laboratory Control System Operations in a GMP Environment

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David M. Bliesner. Laboratory Control System Operations in a GMP Environment

Table of Contents

List of Tables

List of Illustrations

Guide

Pages

Laboratory Control System Operations in a GMP Environment

Preface

Note

About the Companion Website

1 Introduction to the Quality Systems Based Approach to CGMP Compliance. Overview of Quality Systems and the Laboratory Control System

Regulations and Regulatory Bodies

Regulatory Guidance

Application of This Text

Overlap and Redundancy

Tools and Templates

References

Note

2 Components of the Laboratory Managerial and Administrative Systems Sub Element (MS) Description of the Laboratory Managerial and Administrative Systems Sub Element

Contents of the Sub Element

Tools and Templates

Reference

3 Components of the Laboratory Documentation Practices and Standard Operating Procedures Sub Element (OP) Description of the Laboratory Documentation Practices and Standard Operating Procedures Sub Element

Contents of the Sub Element

Tools and Templates

4 Components of the Laboratory Equipment Sub Element (LE) Description of the Laboratory Equipment Sub Element

Contents of the Sub Element

Model Standard Operating Procedures for Establishing and Maintaining an Effective Laboratory Equipment Program

Tools and Templates

References

5 Components of the Laboratory Facilities Sub Element (LF) Description of the Laboratory Facilities Sub Element

Contents of the Sub Element

Tools and Templates

References

6 Components of the Method Validation and Method Transfer Sub Element (MV) Description of the Method Validation and Method Transfer Sub Element

Contents of the Sub Element

Tools and Templates

Glossary

References

7 Components of the Laboratory Computer Systems Sub Element (LC) Description of the Laboratory Computer Systems Sub Element

Contents of the Sub Element

Tools and Templates

Glossary

References

8 Components of the Laboratory Investigations Sub Element (LI) Background and Regulatory History of Out-of-Specification Investigations

Description of the Laboratory Investigations Sub Element

Contents of the Sub Element

Common Problems Related to Laboratory OOS Investigations

Tools and Templates

Glossary

References

9 Components of the Laboratory Data Governance and Data Integrity Sub Element (DI) Background

Precepts Regarding Data Governance and Data Integrity

Description of the Laboratory Data Governance and Data Integrity Sub Element

Contents of the Sub Element

Policy for Data Governance

Procedural Controls

Technical Controls

Data Maps and Data Walks

Risk Identification, Ranking, and Filtering

Data Reviews

Data and Operational Audits

Employee Awareness and Training

Management Oversight

Tools and Templates

Glossary

References

Further Reading

10 Components of the Stability Program Sub Element (SB) Description of the Stability Program Sub Element

Contents of the Sub Element

Model Standard Operating Procedures for Establishing and Maintaining a Stability Program

Stability Chambers

Tools and Templates

Glossary1

References

Note

11 Components of the General Laboratory Compliance Practices Sub Element (CP) Description of the General Laboratory Compliance Practices Sub Element

Contents of the Sub Element

Tools and Templates

12 Summary for Establishing and Maintaining a Laboratory Control System. A Brief Review of the Laboratory Control System and Its Sub Elements

How Things Can Go Wrong: Examples of Some Regulatory Citations Organized by Sub Element

Some Final Thoughts on Establishing and Maintaining a Compliance Laboratory Control System

Index

WILEY END USER LICENSE AGREEMENT

Отрывок из книги

David M. Bliesner, Ph.D.

Delphi Analytical Services, Inc.

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There are numerous other country-specific bodies, which enforce their own laws related to the manufacturing, processing, packing, or holding of drugs. The reader is encouraged to consult the requirements of their own country's laws and regulations regarding the manufacture of pharmaceuticals.

Traditionally, Regulatory Agencies themselves have provided limited insight and assistance into how organizations operating within the pharmaceutical industry can comply with the regulations. However, over time, regulatory guidances and other instruments have arisen and evolved and today consist of a fairly large body of knowledge, which can be used by organizations to aid in compliance with the CGMPs.

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