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    MQA102T

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    This document outlines a course on Quality Management Systems for a Master's program in Pharmaceutical Quality Assurance. The course covers topics such as cGMP, quality certifications, documentation, and the roles of quality assurance and quality control departments. It aims to help students understand key quality systems like ISO standards, change management, complaints handling, and statistical process control. The course contents are divided into six sections spanning topics from quality strategy and customer focus to regulatory compliance, benchmarking, and drug stability. References for further reading are also provided.

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    MQA102T

    Uploaded by

    dinesh111180
    369 views2 pages
    This document outlines a course on Quality Management Systems for a Master's program in Pharmaceutical Quality Assurance. The course covers topics such as cGMP, quality certifications, documentation, and the roles of quality assurance and quality control departments. It aims to help students understand key quality systems like ISO standards, change management, complaints handling, and statistical process control. The course contents are divided into six sections spanning topics from quality strategy and customer focus to regulatory compliance, benchmarking, and drug stability. References for further reading are also provided.

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    This document outlines a course on Quality Management Systems for a Master's program in Pharmaceutical Quality Assurance. The course covers topics such as cGMP, quality certifications, documentation, and the roles of quality assurance and quality control departments. It aims to help students understand key quality systems like ISO standards, change management, complaints handling, and statistical process control. The course contents are divided into six sections spanning topics from quality strategy and customer focus to regulatory compliance, benchmarking, and drug stability. References for further reading are also provided.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    369 views2 pages

    MQA102T

    Uploaded by

    dinesh111180
    This document outlines a course on Quality Management Systems for a Master's program in Pharmaceutical Quality Assurance. The course covers topics such as cGMP, quality certifications, documentation, and the roles of quality assurance and quality control departments. It aims to help students understand key quality systems like ISO standards, change management, complaints handling, and statistical process control. The course contents are divided into six sections spanning topics from quality strategy and customer focus to regulatory compliance, benchmarking, and drug stability. References for further reading are also provided.

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    of 2

    GUJARAT TECHNOLOGICAL UNIVERSITY

    M.Pharm
    PHARMACEUTICAL QUALITY ASSURANCE
    SEMESTER: I
    Subject Name: QUALITY MANAGEMENT SYSTEMS
    Subject Code: MQA102T

    Scope: This course deals with the various aspects of quality control and quality assurance aspects of
    pharmaceutical industries. It covers the important aspects like cGMP, QC tests, documentation, quality
    certifications, GLP and regulatory affairs.

    Objectives: Upon completion of this course the student should be able to


    1. Understand the cGMP aspects in a pharmaceutical industry
    2. To appreciate the importance of documentation
    3. To understand the scope of quality certifications applicable to Pharmaceutical industries
    4. To understand the responsibilities of QA & QC departments.

    Sr Course Contents Total Hrs


    No
    1 Introduction to Quality: Evolution of Quality, Definition of Quality, 12
    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.
    2 Pharmaceutical quality Management: Basics of Quality Management, Total 12
    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.
    3 Six System Inspection model: Quality Management system, Production 12
    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.
    4 Drug Stability: ICH guidelines for stability testing of drug substances and 12
    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.
    5 Statistical Process control (SPC): Definition and Importance of SPC, Quality 8
    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.
    6 Regulatory Compliance through Quality Management and development of 4
    Quality Culture Benchmarking: Definition of benchmarking, Reasons for
    benchmarking, Types of Benchmarking, Benchmarking process, Advantages
    of benchmarking, Limitations of benchmarking.

    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.

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