Laboratory Control System Operations in a GMP Environment (eBook)

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.

Preface

1. Chapter 1: Introduction to the Quality Systems Based Approach to CGMP Compliance

1.1. Overview of Quality Systems and the Laboratory Control System

1.2. Regulations and Regulatory Bodies

1.3. Regulatory Guidance

1.4. Application of This Text

1.5. Overlap and Redundancy

1.6. Tools and Templates

1.7. References

2. Chapter 2: Components of the Laboratory Managerial and Administrative Systems Sub Element (MS)

2.1. Description of the Laboratory Managerial and Administrative System Sub Element

2.2. Contents of the Sub Element

2.3. Tools and Templates

2.4. References

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

3.1. Description of the Laboratory Documentation Practices and Standard Operating Procedures Sub Element

3.2. Contents of the Sub Element

3.3. Tools and Templates

4. Chapter 4: Components of the Laboratory Equipment Sub Element (Le)

4.1. Description of the Laboratory Equipment Sub Element

4.2. Contents of the Sub Element

4.3. Tools and Templates

4.4. References

5. Chapter 5: Components of the Laboratory Facilities Sub Element (LF)

5.1. Description of the Laboratory Facilities Sub Element

5.2. Contents of the Sub Element

5.3. Tools and Templates

5.4. References

6. Chapter 6: Components of the Method Validation and Method Transfer Sub Element (MV)

6.1. Description of the Method Validation and Method Transfer Sub Element

6.2. Contents of the Sub Element

6.3. Tools and Templates

6.4. References

6.5. Glossary

7. Chapter 7: Components of the Laboratory Computer Systems Sub Element (LC)

7.1. Description of the Laboratory Computer Systems Sub Element

7.2. Contents of the Sub Element

7.3. Tools and Templates

7.4. References

7.5. Glossary

8. Chapter 8: Components of the Laboratory Investigations Sub Element (Li)

8.1. Background and Regulatory History of Out-of-Specification Investigations

8.2. Description of the Laboratory Investigations Sub Element

8.3. Contents of the Sub Element

8.4. Tools and Templates

8.5. References

8.6. Glossary

9. Chapter 9: Components of the Laboratory Data Governance and Data Integrity Sub Element (DI)

9.1. Background

9.2. Precepts Regarding Data Governance and Data Integrity

9.3. Description of the Laboratory Data Governance and Data Integrity Sub Element

9.4. Contents of the Sub Element

9.5. Tools and Templates

9.6. References

9.7. Bibliography

9.8. Glossary

10. Chapter 10: Components of the Stability Program Sub Element (SB)

10.1. Description of the Stability Program Sub Element

10.2. Content of the Sub Element

10.3. Tools and Templates

10.4. References

10.5. Glossary

11. Chapter 11: Components of the General Laboratory Compliance Practices Sub Element (CP)

11.1. Description of the General Laboratory Compliance Practices Sub Element

11.2. Content of the Sub Element

11.3. Tools and Templates

12. Chapter 12: Summary for Establishing and Maintaining a Laboratory Control System

12.1. A Brief Review of the Laboratory Control System and Its Sub Elements

12.2. How Things Can Go Wrong: Examples of Some Regulatory Citations

12.3. Some Final Thoughts on Establishing and Maintaining a Compliant Laboratory Control System

Index