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Good Laboratory Practices and Compliance Monitoring
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This handbook is fully updated to the current regulatory requirement in the pharmaceutical laboratory world. Purpose of book is to assist individual on Gx Prequirement, good manufacturing practices, good laboratory practices, performance monitoring and root cause analysis and quality triangles
The purpose of this hand book is to provide easily accessible knowledge about the good laboratory practices. In current pharmaceutical world we need a fast and reliable source of techniques to implement the system and resolve problem. This handbook gives pathway for us to take right decision. Nothing comes in one box for us. Changes happen with or without us. The higher we go in the organization, the more complex ore challenges become .This book gives overall view of quality laboratory system.
We hope this handbook can contributes to assemble lots of related materials and package them in one place for easy reference and access.
I encourage you to read, enjoy, study and learn from this book and go forth and empower you/ your teams to lead you and your organization to world class results.
Contents:
1. Overview of Good Laboratory Practices in Pharmaceutical Industry2. Overview of Good Microbiology Practices in Pharmaceutical Industry3. Quality Assurance Management in GLP Environment4. Laboratory Quality Manual5. Laboratory Quality Policy6. Laboratory Site Master Files7. Validation Master Plan8. Laboratory Computer-Software Validation and Qualification9. Control of Spreadsheets in GLP10. Analytical Instrument and Equipment Qualification11. Electronic and Paper-Based Data Management in GLP12. Laboratory Training and Qualification Management Program13. Reviewer Qualification Management14. Label Management in GLP Environment15. Glassware Management in GLP16. GLP Column Management17. GLP Standard Operating Procedure (SOP) Management18. GLP Specification Management19. GLP Certificate of Analysis (COA) Management20. Analytical Rounding of Results21. Handling of Residual Solvent22. Reserve Sample Management23. Pharmaceutical Product Stability Management24. Good Chromatographic Integration Practice in GLP25. Management of unknown and Extraneous Peaks in Chromatographic Tests26. Quality Agreements in Laboratory27. Sampling and Testing in Laboratory Management28. Laboratory Standard Management29. Analytical Reagent, Indicators and Volumetric Solution Management30. Statistical Tools for Pharmaceutical Industry31. Failure Investigation: To Prevent Reoccurrence32. Laboratory Failure Investigation Management Report Writing33. Deviation Management in Good Laboratory Practices34. Handling of Out of Trend (OOT) Result in Laboratory Management35. Handling of out of Specification Laboratory Results36. Pharmaceutical Change Control Management37. Data Integrity in Pharmaceutical Quality Control Laboratories38. Alarm Management in Good Laboratory Practices39. Handling of Objectionable Organisms – The Regulatory Perspective40. Quality by Design (QBD) Approach in the Product Life Cycle41. Validation Master Plan (Vmp)42. Audit in Laboratory Management43. Laboratory Environment Condition and Monitoring44. Laboratory Quality Standards Management45. Laboratory Instrument Calibration Program46. Laboratory Safety Management Program47. Roll Back Good Analytical Practices48. Laboratory Entry-Exit Procedure
About the Author:
Trupti Patil-Dongare has over 16 years of experience in pharmaceutical industry. Trupti has completed Doctor of Philosophy in Pharmacy, Master's in industrial pharmacy, Advance Diploma in Quality Assurance and IRCA approved ISO 9001:2015 Lead Auditor.
Versatile knowledge on all key pharmaceutical function, provides technical and regulatory consulting to the pharmaceutical industry for the manufacturers of dosage forms, bulk drugs and clinical research labs. The areas of technical and consulting include validation, regulatory submissions, quality systems, facility audits, product specifications, process upgrades, product development, BA/BE clinical research and batch certification for clients. Facility design, infrastructure development and improvement for manufacturing plants for APIs, oral solids, topicals, injectables and ophthalmics for regular, oncologic and beta lactam type products in US, Europe and India with respective to quality and regulatory compliance.
The purpose of this hand book is to provide easily accessible knowledge about the good laboratory practices. In current pharmaceutical world we need a fast and reliable source of techniques to implement the system and resolve problem. This handbook gives pathway for us to take right decision. Nothing comes in one box for us. Changes happen with or without us. The higher we go in the organization, the more complex ore challenges become .This book gives overall view of quality laboratory system.
We hope this handbook can contributes to assemble lots of related materials and package them in one place for easy reference and access.
I encourage you to read, enjoy, study and learn from this book and go forth and empower you/ your teams to lead you and your organization to world class results.
Contents:
1. Overview of Good Laboratory Practices in Pharmaceutical Industry2. Overview of Good Microbiology Practices in Pharmaceutical Industry3. Quality Assurance Management in GLP Environment4. Laboratory Quality Manual5. Laboratory Quality Policy6. Laboratory Site Master Files7. Validation Master Plan8. Laboratory Computer-Software Validation and Qualification9. Control of Spreadsheets in GLP10. Analytical Instrument and Equipment Qualification11. Electronic and Paper-Based Data Management in GLP12. Laboratory Training and Qualification Management Program13. Reviewer Qualification Management14. Label Management in GLP Environment15. Glassware Management in GLP16. GLP Column Management17. GLP Standard Operating Procedure (SOP) Management18. GLP Specification Management19. GLP Certificate of Analysis (COA) Management20. Analytical Rounding of Results21. Handling of Residual Solvent22. Reserve Sample Management23. Pharmaceutical Product Stability Management24. Good Chromatographic Integration Practice in GLP25. Management of unknown and Extraneous Peaks in Chromatographic Tests26. Quality Agreements in Laboratory27. Sampling and Testing in Laboratory Management28. Laboratory Standard Management29. Analytical Reagent, Indicators and Volumetric Solution Management30. Statistical Tools for Pharmaceutical Industry31. Failure Investigation: To Prevent Reoccurrence32. Laboratory Failure Investigation Management Report Writing33. Deviation Management in Good Laboratory Practices34. Handling of Out of Trend (OOT) Result in Laboratory Management35. Handling of out of Specification Laboratory Results36. Pharmaceutical Change Control Management37. Data Integrity in Pharmaceutical Quality Control Laboratories38. Alarm Management in Good Laboratory Practices39. Handling of Objectionable Organisms – The Regulatory Perspective40. Quality by Design (QBD) Approach in the Product Life Cycle41. Validation Master Plan (Vmp)42. Audit in Laboratory Management43. Laboratory Environment Condition and Monitoring44. Laboratory Quality Standards Management45. Laboratory Instrument Calibration Program46. Laboratory Safety Management Program47. Roll Back Good Analytical Practices48. Laboratory Entry-Exit Procedure
About the Author:
Trupti Patil-Dongare has over 16 years of experience in pharmaceutical industry. Trupti has completed Doctor of Philosophy in Pharmacy, Master's in industrial pharmacy, Advance Diploma in Quality Assurance and IRCA approved ISO 9001:2015 Lead Auditor.
Versatile knowledge on all key pharmaceutical function, provides technical and regulatory consulting to the pharmaceutical industry for the manufacturers of dosage forms, bulk drugs and clinical research labs. The areas of technical and consulting include validation, regulatory submissions, quality systems, facility audits, product specifications, process upgrades, product development, BA/BE clinical research and batch certification for clients. Facility design, infrastructure development and improvement for manufacturing plants for APIs, oral solids, topicals, injectables and ophthalmics for regular, oncologic and beta lactam type products in US, Europe and India with respective to quality and regulatory compliance.
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