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, Q1 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. 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 1 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 1: A Pragmatic Approach 19 Compliance Aspects of APIs Manufacturing 2 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 Index

About the Author

Madhu Raju Saghee is working in corporate quality department at Gland Pharma, India. He is responsible for implementing a robust quality system, ensuring regulatory compliance and involved in qualification and validation of sterile and aseptic manufacture for parenterals. Madhu has a Master of Science in Microbiology, an active member of various industry associations, including PDA, PHSS and ISPE and Director for Indian region of Pharmaceutical and Healthcare Sciences Society (PHSS).