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About the Book:

This handbook has been written for the students of pharmacy and pharmaceutical industry. It gives pocket guide of good manufacturing practices in pharmaceutical industry. The purpose of this handbook is to provide easily accessible knowledge about the pharmaceutical industry and to assist individuals to know about pharmaceutical world. This handbook has also incorporated the current trends and expectations of the evolving pharmaceutical industry and regulatory oversight.

            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 a one box for us. Changes happen with or without us. The higher we go in the organization, the more complex our challenges become. This book gives overall view of quality management system.

            We hope this handbook can contribute 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 your teams to lead you and your organization to world class results.

Contents:

1. GMP Regulations for Pharmaceutical Industry

2. Good Laboratory Practices in Pharmaceutical Industry

3. Good Microbiology Practice in Pharmaceutical Industry

4. Good Aseptic Practices in Pharmaceutical Industry

5. Good Clean Room Monitoring in Pharmaceutical Industry

6. Good Engineering Practices in Pharmaceutical Industry

7. Good Alarm Management Practices in Pharmaceutical Industry

8. Good Computer Validation System Practices in Pharmaceutical Industry

9. Good Distribution Practices—Supply Chain Integrity in Pharmaceutical Industry

10. Good Data Management System in Pharmaceutical Industry

11. Quality Agreements in Pharmaceutical Industry

12. Change control Management and its Applications

13. Technology Transfer of Pharmaceutical Product

14. Pharmaceutical Annual Product Quality Review

15. Statistical Tools for Pharmaceutical Industry

16. Application of Different Quality Tools in Investigation of Non-Conformance Observations

17. New Approach to the Internal Audit from Traditional to Risk based Approach

18. Quality by Design (QbD) Approach in the Product Life Cycle

19. Process Validation in Pharmaceutical Industry

20. Cleaning Validation and Cross Contamination Approach on Risk MaPP Concept

21. Pharmaceutical Water Generation and Distribution System and Regulatory Expectation

22. Pharmaceutical Heating, Ventilation and Air Conditionings (HVAC) and Regulatory Expectations

23. Manufacturing Execution System (MES) in Pharmaceutical Industry

24. Pharmaceutical Drug Master File

25. Common Technical Document in Regulatory Filing

26. European Union Marketing Authorization

27. Site Master File

28. Standard Operating Procedure (SOP)

29. Quality Manual

30. Human Error Reduction: Pharma Industry Challenge

31. Regulatory Inspections: Face Challenges through Proactive Measures

32. Pharmaceutical GMP: Past, Present, and Future – A Review

About the Author:

Trupti Patil-Dongare has over 14 years of experience in pharmaceutical industry in quality assurance, quality Control, regulatory compliance and production. I am Master in Industrial Pharmacy from Osmania University, Hyderabad, India and Advance Diploma in Pharmaceutical Quality Assurance Management from Institute of Pharmaceutical Education and Research Pune, Maharashtra, India.

            Versatile knowledge on all key functions of Non sterile API, Sterile API and formulation QA. Ample exposure to Regulatory affairs for filling the ANDAs, DMFs & Dossiers. Preparing, responding and committing to the regulatory bodies for deficiencies and queries. Knowledge on various national & international standards.

         Skilled in Quality Audits, Contract manufacturing, loan licensing sites (Sterile & non-sterile) & analytical testing sites.