Total Quality Management Pharmaceuticals
MEDICINE/pharmaceuticals Medicine / Brand/ Product
Pharma Compliance
Compliance – Quality TWO SIDES OF THE SAME COIN!
Moving towards Quality Inspection Quality Assurance SPC TQM TQC
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
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
“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
Practice Infrastructure Tools & Techniques Customer focus Continuous improvement & learning Participation & team work TQM
TQ-Infrastructure Customer Relationship Management Leadership and strategic planning Human Resources Management Process management Information and knowledge management
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)
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
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
QS Elements Process perf. & quality monitoring CAPA SYSTEM CHANGE MGT. MGT.REVIEW
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
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
TQM in Pharma- Looking beyond Systems /Processes People
TOTAL QUALITY MANAGEMENT - YouTube (360p).mp4