1. Total Quality Management Pharmaceuticals

2. MEDICINE/pharmaceuticals Medicine / Brand/ Product

5. Pharma Compliance

6. Compliance – Quality TWO SIDES OF THE SAME COIN!

7. Moving towards Quality Inspection Quality Assurance SPC TQM TQC

8. Three levels of Quality ORG. Identifying unmet needs Identifying products that meet expectations PRO. Identify processes Work on key inputs, significance JOB Measurements of requirements Standards

9. Total Quality-Principles Customer and stakeholder focus Design Respond to changing needs Participation and teamwork Freedom to contribute, make decisions Marriott-” associates” Horizontal linkages Cross –functional teams Process focus and continuous improvement

10. “Management approach of an organisation centred on quality, based on the participation of all its members and aiming at long term success through customer satisfaction and benefits to all members of the organisation and to society” ISO 8402 definition TQM

11. Practice Infrastructure Tools & Techniques Customer focus Continuous improvement & learning Participation & team work TQM

12. TQ-Infrastructure Customer Relationship Management Leadership and strategic planning Human Resources Management Process management Information and knowledge management

13. QUALITY SYSTEMS “Quality should be built into the products and testing alone cannot be relied on to ensure product quality”…..FDA Quality? (as per cGMP)

14. Manufacturing: FDA perspective Design of effective and efficient manufacturing processes Product and process specifications based on understanding of how formulation and process factors affect product performance Continuous real-time QA

15. MANUFACTURING…. Relevant regulatory policies and procedures tailored to accommodate the most current level of scientific knowledge Risk based regulatory approaches that recognize Formulation process and manufacturing process factors Capability of process control strategies

16. QS Elements Process perf. & quality monitoring CAPA SYSTEM CHANGE MGT. MGT.REVIEW

17. ICH Q10.. ICH Q8 Pharmaceutical Development ICH Q9 Quality Risk Management Product life cycle Innovation Continual improvement Strengthen the link between mfg. and development activities

19. Risk management Manufacturing Implementation Process Scale-up & Tech Transfer Risk Management Process Development Product Development Product quality control strategy Risk Control Risk Assessment Process design space Process Understanding Excipient & drug substance design space Product/prior Knowledge Risk Assessment Continual improvement Process History Risk Review

20. TQM in Pharma- Looking beyond Systems /Processes People

21. TOTAL QUALITY MANAGEMENT - YouTube (360p).mp4