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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
• Identifying unmet needs
ORG. • Identifying products that meet expectations
• Identify processes
PRO. • 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
TQM
• “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
Practice
TQM
Participation & team work
Infrastructure
Tools &
Techniques
TQ-Infrastructure
Customer
Relationship
Management
Leadership and
strategic
planning
Process
management
Human
Resources
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
Product
Development
Process
Development
Process Scale-up
& Tech Transfer
Manufacturing
Implementation
Product/prior
Knowledge
Process
Understanding
Risk
Assessment
Risk
Assessment
Risk
Control
Risk
Review
Excipient &
drug substance
design space
Process
design space
Product quality
control strategy
Continual
improvement
Process
History
Risk Management
TQM in Pharma- Looking beyond
• Systems /Processes
• People
• TOTAL QUALITY MANAGEMENT - YouTube (360p).mp4