JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objective

This course is designed to impart fundamental knowledge and concepts about

various quality management principles and systems utilized in the manufacturing industry. It also aids in understanding the quality evaluation in the pharmaceutical industries.

Course Outcome

At completion of this course it is expected that students will be able to understand;

• The importance of quality
• ISO management systems
• Tools for quality improvement
• Analysis of issues in quality
• Quality evaluation of pharmaceuticals
• Stability testing of drug and drug substances
• Statistical approaches for quality

UNIT - I

Introduction to Quality: Evolution of Quality, Definition of Quality, Dimensions of Quality Quality as a Strategic Decision: Meaning of strategy and strategic quality management, mission and vision statements, quality policy, Quality objectives, strategic planning and implementation, McKinsey 7s model, Competitive analysis, Management commitment to quality Customer Focus: Meaning of customer and customer focus, Classification of customers, Customer focus, Customer perception of quality, Factors affecting customer perception, Customer requirements, Meeting customer needs and expectations, Customer satisfaction and Customer delight, Handling customer complaints, Understanding customer behavior, concept of internal and external customers. Case studies. Cost of Quality: Cost of quality, Categories of cost of Quality, Models of cost of quality, Optimising costs, preventing cost of quality.

UNIT - II

Pharmaceutical quality Management: Basics of Quality Management, Total Quality Management (TQM), Principles of Six sigma, ISO 9001:2008, 9001:2015, ISO 14001:2004, Pharmaceutical Quality Management – ICH Q10, Knowledge management, Quality Metrics, Operational Excellence and Quality Management Review. OSHAS guidelines, NABL certification and accreditation, CFR-21 part 11, WHO- GMP requirements.

UNIT - III

Six System Inspection model: Quality Management system, Production system, Facility and Equipment system, Laboratory control system, Materials system, Packaging and labeling system. Concept of self inspection. Quality systems: Change Management/ Change control. Deviations, Out of Specifications (OOS), Out of Trend (OOT), Complaints - evaluation and handling, Investigation and determination of root cause, Corrective & Preventive Actions (CAPA), Returns and Recalls, Vendor Qualification, Annual Product Reviews, Batch Review and Batch Release. Concept of IPQC, area clearance/ Line clearance.

UNIT - IV

Drug Stability: ICH guidelines for stability testing of drug substances and drug products. Study of ICH Q8, Quality by Design and Process development report Quality risk management: Introduction, risk assessment, risk control, risk review, risk management tools, HACCP, risk ranking and filtering according to ICH Q9 guidelines.

R19 M.PHARM PHARMACEUTICAL QUALITY ASSURANCE

UNIT - V

statistical Process control (SPC): Definition and Importance of SPC, Quality measurement in manufacturing, Statistical control charts - concepts and general aspects, Advantages of statistical control, Process capability, Estimating Inherent or potential capability from a control chart analysis, Measuring process control and quality improvement, Pursuit of decreased process variability. Regulatory Compliance through Quality Management and development of Quality Culture Benchmarking: Definition of benchmarking, Reasons for benchmarking, Types of Benchmarking, Benchmarking process, Advantages of benchmarking, Limitations of benchmarking.

TEXT BOOKS AND REFERENCES:

• 1. Implementing Juran's Road Map for Quality Leadership: Benchmarks and Results, By Al Endres, Wiley, 2000
• 2. Understanding, Managing and Implementing Quality: Frameworks, Techniques and Cases, By Jiju Antony; David Preece, Routledge, 2002
• 3. Organizing for High Performance: Employee Involvement, TQM, Reengineering, and Knowledge Management in the Fortune 1000: The CEO Report By Edward E. Lawler; Susan Albers Mohrman; George Benson, Jossey-Bass, 2001
• 4. Corporate Culture and the Quality Organization By James W. Fairfield- Sonn, Quorum Books, 2001
• 5. The Quality Management Sourcebook: An International Guide to Materials and Resources By Christine Avery; Diane Zabel, Routledge, 1997
• 6. The Quality Toolbox, Second Edition, Nancy R. Tague, ASQ Publications
• 7. Juran's Quality Handbook, Sixth Edition, Joseph M. Juran and Joseph A. De Feo, ASQ Publications
• 8. Root Cause Analysis, The Core of Problem Solving and Corrective Action, Duke Okes, 2009, ASQ Publications. R19 M.PHARM PHARMACEUTICAL QUALITY ASSURANCE M.Pharm I Year I Sem (Pharmaceutical Quality Assurance)