Quality is built into processes instead of improved with additional testing or inspections

1. Quality Management Systems
(QMS)
By: Ph. HuSSaM KaSSaB

3. “A Pharmaceutical Quality System (PQS) is a management system to
direct and control a pharmaceutical company in terms of quality.”
This definition of ICH Q10 is based on the definition from the family of
ISO 9000 standards

4. Quality relationships
Quality Management
Quality Assurance
GMP
Production and Quality
Control

5. Quality is built into processes instead of improved
with additional testing or inspections.

6. Quality refers to all those features
of a product (or service) which are
required by the customer.
Quality management means
what the organization does to
1-ensure that its products or
services satisfy the customer's
quality requirements
2-comply with any regulations
applicable to those products or
services.

7. Customer
Focus
Leadership
Engagement of
People
Process
Approach
Improvement
Evidence-Based
Decision Making
Relationship
Management
• Increased
customer
value.
• Increased
customer
satisfaction.
• Improved
customer
loyalty.
• Enhanced
repeat
business.
• Enhanced
reputation of
the
organization.
• Expanded
customer
base.
• Increased
revenue and
market
share.

8. Customer Focus
Leadership
Engagement of
People
Process
Approach
Improvement
Evidence-Based
Decision Making
Relationship
Management
Leaders at all levels establish unity of purpose and
direction and create conditions in which people are
engaged i achieving the organization’s quality objectives.
• Increased
effectiveness and
efficiency in
meeting the
organization’s
quality objectives.
• Better
coordination of the
organization’s
processes.
• Improved
communication
between levels and
functions of the
organization.
• Development and
improvement of the
capability of the
organization and its
people to deliver
desired results.

9. Customer Focus
Leadership
Engagement
of People
Process
Approach
Improvement
Evidence-Based
Decision Making
Relationship
Management
• Improved
understanding of
the organization’s
quality objectives
by people in the
organization and
increased
motivation to
achieve them.
• Enhanced
involvement of
people in
improvement
activities and
attention to shared
values and culture
throughout the
organization
• Enhanced
personal
development,
initiatives and
creativity.
• Enhanced people
satisfaction and
trust and
collaboration
throughout the
organization.

10. Customer Focus
Leadership
Engagement of
People
Process
Approach
Improvement
Evidence-Based
Decision Making
Relationship
Management
PLAN-DO-CHECK-ACT (PDCA)

11. Customer Focus
Leadership
Engagement of
People
Process
Approach
Improvement
Evidence-Based
Decision Making
Relationship
Management
• Improved process
performance,
organizational
capabilities and
customer satisfaction. • Enhanced focus on
root-cause
investigation and
determination,
followed by
prevention and
corrective actions.
• Enhanced ability to
anticipate and react
to internal and
external risks and
opportunities.
• Enhanced
consideration of both
incremental and
breakthrough
improvement.
• Improved
use of learning
for
improvement.
• Enhanced
drive for
innovation.

12. Customer Focus
Leadership
Engagement of
People
Process
Approach
Improvement
Evidence-Based
Decision
Making
Relationship
Management
• Improved
decision-
making
processes.
• Improved
assessment of
process
performance
and ability to
achieve
objectives.
• Improved
operational
effectiveness
and efficiency.
• Increased
ability to
review,
challenge and
change
opinions and
decisions.
• Increased
ability to
demonstrate
the
effectiveness of
past decisions.

13. Customer Focus
Leadership
Engagement of
People
Process
Approach
Improvement
Evidence-Based
Decision Making
Relationship
Management
• Enhanced performance of the organization and its interested
parties through responding to the opportunities and constraints
related to each interested party.
• Common understanding of goals and values among interested
parties.
• Increased capability to create value for interested parties by
sharing resources and competence and managing quality-related
risks.
• A well-managed supply chain that provides a stable flow of
goods and services.

14. QA System should ensure:
• Starting materials, intermediate products, bulk products are controlled
• In-process controls, calibrations, and validations are carried out
• Finished products are correctly processed and checked
• Products are not sold or supplied before release by authorized persons
• Systems ensure that products are appropriately stored and distributed
Quality Management

15. QA System should ensure:
• Self-inspection and/or quality audits are done regularly
• Deviations are reported, investigated and recorded
• Changes are controlled
• Systems are followed to verify the consistency of processes and
ensuring continuous improvement
• Quality Risk Management is implemented

16. Quality Assurance
• Products must be:
– safety, quality and efficacy requirements - fit for their intended use
– comply with the requirements of the marketing authorization
• Senior management is responsible - and all staff must be committed
to achieve this.
• Relies on a comprehensively designed, documented, correctly
implemented system of QA incorporating GMP and QC.
• Relies on competent personnel, suitable and sufficient premises,
equipment and facilities.

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