1. Dr. Shilpa Bhilegaonkar Total Quality Management and Quality Risk Management

2. Need India big generic manufacturer Generic drugs holds 70 % Market share Supply 20% of global medicines Consistent growth in Indian pharma business with CAGR of 17.46% in 2015 and expected to grow by 2020 with CAGR of 15.92%

3. Need Quality

4. History of quality In Japan during 1960’s In US during 1980’s

5. Sr.No.authoryeartitle 1Walter A. Shewhart 1920Standardization to reduce quality defects 1931“Economic Control of Quality”, 2Joseph M. Juran1940“Pareto analysis” 3Phillip Crosby1940“Quality is Free” 4Arnand V. Feigenbaum 1940“total quality control”

6. Guidelines for quality WHO FDA ICH EU

7. Other approaches and tools to implement quality Six sigma Process capability analysis PAT Total quality management CAPA Risk management QbD Lean manufacturing ISO series HACCP

8. Total quality management total quality management (TQM) means: 1. Satisfying customers first time, every time; 2. Enabling the employees to solve problems and eliminate wastage; 3. A style of working, a culture more than a management technique; 4. Philosophy of continuous improvement, never ending, only achievable by/or through people.

9. Risk management approaches failure modes effects analysis (FMEA) hazard operability analysis (HAZOP) HACCP Diagram analysis Risk ranking and filtering Fault tree analysis

10. Non compliances ?????

11. USFDA warning letters Import ban

12. Reasons for noncompliances Peer pressure Departmental pressure Management pressure Lack of seriousness Achieve targets

13. Compliance Management motivation Automation Partial automation Contract manufacturing

14. Mindset Phillip Crosby (1940) “Quality is Free”

15. Thank you