About the Book:

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.

Contents:

1.    Overview of Good Laboratory Practices in Pharmaceutical Industry

2.    Overview of Good Microbiology Practices in Pharmaceutical Industry

3.    Quality Assurance Management in GLP Environment

4.    Laboratory Quality Manual

5.    Laboratory Quality Policy

6.    Laboratory Site Master Files

7.    Validation Master Plan

8.    Laboratory Computer-Software Validation and Qualification

9.    Control of Spreadsheets in GLP

10. Analytical Instrument and Equipment Qualification

11. Electronic and Paper-Based Data Management in GLP

12. Laboratory Training and Qualification Management Program

13. Reviewer Qualification Management

14. Label Management in GLP Environment

15. Glassware Management in GLP

16. GLP Column Management

17. GLP Standard Operating Procedure (SOP) Management

18. GLP Specification Management

19. GLP Certificate of Analysis (COA) Management

20. Analytical Rounding of Results

21. Handling of Residual Solvent

22. Reserve Sample Management

23. Pharmaceutical Product Stability Management

24. Good Chromatographic Integration Practice in GLP

25. Management of unknown and Extraneous Peaks in Chromatographic Tests

26. Quality Agreements in Laboratory

27. Sampling and Testing in Laboratory Management

28. Laboratory Standard Management

29. Analytical Reagent, Indicators and Volumetric Solution Management

30. Statistical Tools for Pharmaceutical Industry

31. Failure Investigation: To Prevent Reoccurrence

32. Laboratory Failure Investigation Management Report Writing

33. Deviation Management in Good Laboratory Practices

34. Handling of Out of Trend (OOT) Result in Laboratory Management

35. Handling of out of Specification Laboratory Results

36. Pharmaceutical Change Control Management

37. Data Integrity in Pharmaceutical Quality Control Laboratories

38. Alarm Management in Good Laboratory Practices

39. Handling of Objectionable Organisms – The Regulatory Perspective

40. Quality by Design (QBD) Approach in the Product Life Cycle

41. Validation Master Plan (Vmp)

42. Audit in Laboratory Management

43. Laboratory Environment Condition and Monitoring

44. Laboratory Quality Standards Management

45. Laboratory Instrument Calibration Program

46. Laboratory Safety Management Program

47. Roll Back Good Analytical Practices

48. 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.