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

1 Cover

2 Preface Note

3 About the Companion Website

4 1 Introduction to the Quality Systems Based Approach to CGMP ComplianceOverview 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 Control SystemA 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

16 Index

17 End User License Agreement

1 Chapter 2 Table 2.1 Components of the laboratory managerial and administrative systems ...

2 Chapter 3 Table 3.1 Model master laboratory SOP index. Table 3.2 Model master laboratory SOP index with details.

3 Chapter 4Table 4.1 Components of the laboratory equipment program.Table 4.2 Suggestions for laboratory equipment-specific Standard Operating Pr...

4 Chapter 5Table 5.1 Components of the laboratory facilities sub element.

5 Chapter 6Table 6.1 Components of the method validation and Method Transfer sub element...

6 Chapter 7Table 7.1 Components of the laboratory computers system sub element.

7 Chapter 8Table 8.1 Description of the phases of a laboratory investigation.

8 Chapter 9Table 9.1 ALCOA+ acronym for data integrity.Table 9.2 Example gap analysis for manufacturing steps.Table 9.3 Example gap analysis for a laboratory instrument data map.Table 9.4a Example risk ranking and filtering tool: Risk definitions.Table 9.4b Example risk ranking and filtering tool: Risk score calculationsTable 9.4b Some Example Lines from the Risk Ranking and Filtering ToolTable 9.5 Example notebook and data review checklist.

9 Chapter 10Table 10.1 Components of the stability program.Table 10.2 Selection, qualification, calibration, and maintenance of stabilit...

10 Chapter 11Table 11.1 Components of the general laboratory compliance practices sub elem...

11 Chapter 12Table 12.1 The laboratory control system sub elements and some example regula...

1 Chapter 1 Figure 1.1 FDA guidance for Industry Quality Systems approach to pharmaceuti...

2 Chapter 8Figure 8.1 The regulatory history of out-of-specification investigations.Figure 8.2 The structure of laboratory investigations.Figure 8.3 A model laboratory investigations work flow diagram.

3 Chapter 9Figure 9.1 The lifecycle of laboratory data.Figure 9.2 Data governance and data integrity hierarchy.Figure 9.4 Example Data Map for the manufacture of a drug product.Figure 9.5 A generic laboratory instrument data map.Figure 9.6 Example laboratory data flow for notebook and data review.Figure 9.7 Quality assurance data and operations audit program work flow.

1 Cover

2 Table of Contents

3 Begin Reading

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