The document discusses the quality systems model for management responsibilities in pharmaceutical quality assurance. It describes the five key elements of the quality systems model: 1) quality by design and product development, 2) risk management and assessment, 3) corrective and preventative action, 4) change control, and 5) quality unit and inspection model. It then explains the major parts of the quality systems model in more detail, including management responsibilities, resources, manufacturing operations, and evaluations. Management is responsible for establishing the quality policy, objectives, and ensuring legal and customer requirements are met.

1. THE QUALITY SYSTEMS MODEL
Management Responsibilities
Presented by- Shaifali
M.pharmacy IInd sem.
(Quality assurance)

2. QUALITY SYSTEM APPROACH
TO GMP REGULATIONS
GMP regulations specifically assign the authority to
create, monitor, and implement a quality system.
It is an activity of daily responsibility of
manufacturing personnel to build quality into a
product.

3. CGMP AND MODERN
QUALITY SYSTEMS
1. Quality
2. Quality by design and product development
3. Risk management and risk assesment
4. CAPA
5. Change control
6. Quality unit
7. Six system inspection model

4. QUALITY SYSTEM MODEL
It identifies your business model and processes,
provides details about how your people will work
together to get things done and establishes
specifications for performance.
It is like blueprint of your organisations.
So this model can help to identify that you’re on track
or not. Its a living, breathing system.

5. CONT……..
The model is organised into major parts.
A. Management responsibilities
B. Resources
C. Manufacturing operations
D. Evaluations

6. MANAGEMENT
RESPONSIBILITIES
Top management have the following responsibilities that can not be delegated.
A. Establish the quality policy.
B. Ensure quality objectives fit the strategic direction.
C. Ensure the customer and legal requirements.
D. Ensure resources needed for the QMS are available.
E. Engaging, directing and supporting people to participate in the QMS.
F. Ensure that risks and opportunities are identified and addressed.

7. ITS DIVIDED…….
1. Provide leadership
2. Structure the organisation
3. Build your quality system to meet requirements.
4. Establish policies, objectives and plans.
5. Review the system

8. 1. LEADERSHIP
Leadership is the art of motivating a group of people to act
towards achieving a common goal.
The process of encouraging and helping others to work
enthusiastically towards objectives.
Leadership may be defined as the ability to exert interpersonal
influence by means of communication towards the achievement
of a goal.
Leadership involves the establishing a clear vision, sharing that
vision with others so that they will follow willingly.

9. TYPES OF LEADERSHIP
Democratic leaders
Autocratic leaders
Bureaucratic leaders
Charismatic leaders
Laissez faire leaders

10. CHARACTERISTICS OF
LEADERSHIP
Intelligence
Honesty and integrity
Leadership motivation
Self confidence
Knowledge of the business
Emotional maturity
Energy level
Stress tolerance

11. FUNCTIONS OF A LEADER
Policy maker
Planner
Father figure
Exemplar
Arbitrator and mediator
Controller of reward and punishment
Controller of reward and punishment
Executive

12. 2. STRUCTURE OF
ORGANISATIONS
An organisational structure is the term used to define
how employees of a company work together to support
their mission.
In simple term structure is the patterns in which
various parts of components are interrelated or
interconnected.
It is a pattern or arrangement of jobs and groups of
job with in on organisation.

13. FEATURES OF GOOD
ORGANISATIONS STRUCTURE…..
Simplicity
Flexibility and continuity
Clear line authority
Application of ultimate authority
Proper delegation of authority
Proper emphasis of staff
Provision for top management.

14. TYPES OF ORGANISATIONAL
STRUCTURE
Line organisation
Functional organisation
Geographical organisation
Matrix organisation
Line and staff organisation
Divisional organisation
Customer based organisation
Team based organisation structures

15. ADVANTAGES AND
DISADVANTAGES
Specialization
Operational clarity
Operational speed
Segregation
Lack of co-ordination
Weakening of common bonds

16. 3. BUILD YOUR QUALITY SYSTEM
TO MEET REQUIREMENTS
A quality system is defined as the organisational
structure, responsibilities, procedures, processes, and
resources needed to implement quality management.
Elements include, quality manual, instructions,
records, procedures, data management, customer
satisfaction from quality of product.

17. EXAMPLE….
The scope of the quality system.
The standard of quality.
The manufacturer’s policies to implement the quality
system criteria.
The procedures needed to establish and maintain the
quality system.

18. 4. ESTABLISH POLICIES,
OBJECTIVES AND PLANS
The purpose of established policies is to ensure such
continuous improvement through a process of self
evaluation and action planning.
Objectives are measurable goals relevant to enhancing
customer satisfaction and are consistent with the quality
policy. Eg- goals to improve on time delivery, defects etc.
Planning is the first step towards achieving the set goals. QA
planning can be defined as an activity aimed for optimal
resource allocation and goals set for a successful QA process.

19. 5. REVIEW THE SYSTEM
It is a key component in any quality system to ensure
its continuing, suitability, adequacy, and
effectiveness.
It includes both an assessment of the product as well
as customer needs.

20. REVIEW SHOULD
CONSIDER………….
The results of audits and other assessments.
Customer feedback, including complaints.
The analysis of data trending results.
Quality policy and objectives.
Status of CAPA
Any changes in business business practice or environment.
Product characteristics meet the customer’s needs.

21. REVIEW OUTCOMES….
Improvements to the quality system and related
quality processes.
Realignment of resources.
Improvements to manufacturing processes and
products.

22. THANK YOU