Total Quality Management and Quality Risk Management Dr

Total Quality Management and Quality Risk Management Dr. Shilpa Bhilegaonkar

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%

Need Quality

History of quality �In Japan during 1960’s �In US during 1980’s

Sr. No. author year title 1 Walter A. Shewhart 1920 Standardizatio n to reduce quality defects 1931 “Economic Control of Quality”, 2 Joseph M. Juran 1940 “Pareto analysis” 3 Phillip Crosby 1940 “Quality is Free” 4 Arnand V. Feigenbaum 1940 “total quality control”

Guidelines for quality �WHO �FDA �ICH �EU

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

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.

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

�Non compliances ? ? ?

�USFDA warning letters �Import ban

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

Compliance �Management motivation �Automation �Partial automation �Contract manufacturing

�Mindset �Phillip Crosby (1940) “Quality is Free”

Thank you