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

      

      Table of Contents

      1  Cover

      2  Preface Note

      3  About the Companion Website

      4  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

      5  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

      6  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

      7  4 Components of the Laboratory Equipment Sub Element (LE) Description of the Laboratory Equipment Sub Element Contents of the Sub Element Tools and Templates References

      8  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

      9  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

      10  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

      11  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

      12  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 Tools and Templates Glossary References Further Reading

      13  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 Tools and Templates Glossary References Note

      14  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

      15  12 Summary for Establishing and Maintaining a Laboratory