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Achieving Quality and Compliance Excellence in Pharmaceuticals: A Master Class GMP Guide / Saghee, Madhu Raju (Ed.)
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Achieving Quality and Compliance Excellence in Pharmaceuticals: A Master Class GMP Guide
Saghee, Madhu Raju (Ed.)
 
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List Price : US$ 149.94
Our Price : US$ 119.95
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  Book ID : 40449
  ISBN-10 : 81-906467-8-8 / 8190646788
  ISBN-13 : 978-81-906467-8-9 / 9788190646789
  Place of Publication : Delhi
  Year of Publication : 2012
  Edition : (First Edition)
  Language : English
  xx, 663p., Figs., Tables, Index, 25 cm.
   
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 CONTENTS
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CONTENTS:-
1. Fundamentals of Global GMP Requirements
2. Effective CAPA Management for Optimal Compliance
3. Laboratory Compliance and Handling Out-of-Specification (OOS) Results in the Laboratory
4. Effectively Incorporating Quality Risk Management into Quality Systems
5. Monitoring and Controlling Process Drift for Enhancing Quality
6. Qualification and Validation
7. Process Validation
8. Documents, Records, and Part 11 Compliance
9. Change Control and Management
10. Deviation Management
11. Internal Quality Assessments/Self-Audits
12. Designing an Effective GMP Training Program
13. Behavioural GMPS (bGxP®): A New Paradigm in Compliance Management
14. Supplier Quality Management
15. Understanding the United States Pharmacopeia (USP)
16. Spotting Overall Weak GMP Compliance Systems
17. Meaningful Performance Metrics for Compliance
18. Implementing ICH Q 10: A Pragmatic Approach
19. Compliance Aspects of APIs Manufacturing
20. Compliance Aspects of Sterile Manufacturing
21. Domestic and International U.S. Food and Drug Administration (FDA) Inspections
22. Avoiding FDA Enforcement Actions: An Optimal & Sustainable Compliance Program
23. Developing a Master QMS Plan
24. Trends in cGMP Compliance
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 DESCRIPTION
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In todays contemporary pharmaceutical industry, the focus has slowly but surely shifted from the elusive research pipeline and latest blockbuster molecules to current processes, efficiencies and manufacturing systems. A path most often taken by manufacturers today in this direction includes improving their overall quality and compliance efforts. This results in a two-pronged approach of minimizing the litigation cost and concurrently improving the overall quality of the products and efficiencies in their processes and procedures. This book provides current thinking and approaches to achieving quality and compliance from top industry experts and is pioneering in bringing this wealth of information together in a single volume which will be of great use to the pharmaceutical industry. Compliance and quality issues have been comprehensively covered, from GMP requirements to deviation management, OOS and CAPA methodologies, QRM and QMS practical implementation, qualification and validation, records and documentation practices, latest GMP training techniques and performance metrics for compliance and detailed analysis of ICH guidelines for practical implementation.

This book aligns with the FDA’s 21st century initiative and the ICH guidelines focused on quality risk management (ICH Q8, Q9, Q10 and Q11) and underpins the importance of science based decisions and risk evaluation as the centerpiece of compliance policy and execution. It provides a pragmatic framework for establishing a robust quality system.

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