Quality Assurance and Quality Management concepts: Definition and concept of Quality control, Quality assurance and GMP Total Quality Management (TQM): Definition, elements, philosophies ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines Quality by design (QbD): Definition, overview, elements of QbD program, tools ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration NABL accreditation : Principles and procedures

1. 4/28/2024 PRESENTED BY MS. SAYALI POWAR ICH 1
UNIT 1

2. 4/28/2024 PRESENTED BY MS. SAYALI POWAR ICH 2
UNIT 1
• Quality Assurance and Quality Management concepts: Definition and
concept of Quality control, Quality assurance and GMP
• Total Quality Management (TQM): Definition, elements,
philosophies
• ICH Guidelines: purpose, participants, process of harmonization,
Brief overview of QSEM, with special emphasis on Q-series
guidelines, ICH stability testing guidelines
• Quality by design (QbD): Definition, overview, elements of QbD
program, tools
• ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for
registration
• NABL accreditation : Principles and procedures

3. 4/28/2024 PRESENTED BY MS. SAYALI POWAR ICH 3
Quality Assurance and Quality Management
concepts: Definition and concept of Quality
control, Quality assurance and GMP
GMP is that part of Quality assurance which ensures that the
products are consistently manufactured and controlled to the
Quality standards appropriate to their intended use
GMP ensures that quality is built into the organization &
processes involved in manufacture
GMP covers all aspects of manufacture including collection,
transportation, processing, storage, QC & delivery of the finished
product
QC is laboratory based(TESTING)
QA is company based(DOCUMENTATION)

4. Management concepts: Definition
and concept of Quality control,
Quality assurance and GMP
4/28/2024 PRESENTED BY MS. SAYALI POWAR ICH 4

5. 4/28/2024 PRESENTED BY MS. SAYALI POWAR ICH 5
Total Quality Management (TQM):
Definition, elements, philosophies
TQM): Definition: Total Quality Management
(TQM) is a set of management practices
throughout the organization geared to ensure the
organization consistently meets or exceed
customer requirements.
TQM refers to management methods used to
enhance quality, based on the participation of all
members & aiming all long term success through
customers satisfaction & benefits to all
organizations

6. 4/28/2024 PRESENTED BY MS. SAYALI POWAR ICH 6
Total Quality Management (TQM):
Definition, elements, philosophies
According to ISO, TQM is defined as: "A
management approach of an organization
centered 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 organization and society”

7. 4/28/2024 PRESENTED BY MS. SAYALI POWAR ICH 7
Total Quality Management (TQM):
Definition, elements, philosophies
Components of Total quality
Management 1.Quality Planning
2.Quality Control 3.Quality Assurance
4.Quality Improvement

8. 4/28/2024 PRESENTED BY MS. SAYALI POWAR ICH 8
Total Quality Management (TQM):
Definition, elements, philosophies

9. 4/28/2024 PRESENTED BY MS. SAYALI POWAR ICH 9
Total Quality Management (TQM):
Definition, elements, philosophies
The Philosophy of TQM was born out of the concepts
developed by four great gurus of Quality
Management.
1. W. Edwards Deming
2. Joseph M Juran
3. Armand V Feigenbaum
4. Philip Crosby
Dr. W. Edwards Deming: (1900-1993) is considered
to be Father of Modern Quality.

10. 4/28/2024 PRESENTED BY MS. SAYALI POWAR ICH 10
Total Quality Management (TQM):
Definition, elements, philosophies

11. 4/28/2024 PRESENTED BY MS. SAYALI POWAR ICH 11
Total Quality Management (TQM):
Definition, elements, philosophies
2.Joseph M Juran:
He addressed that quality begins at the stage of designing and
ends after satisfactory services are provided to the customers.
His famous definition for quality is ‘fitness for use’.
He recommends a set of four important stages as
1. Establish specific goals to be reached.(Identification of needs
to done, focus on specific project etc.)
2. Establish plan for reaching goals (Development of structured
process to achieve this)
3. Assign clear responsibility for reaching goals.
4. Give rewards/ awards on the basis of result achieved.

12. 4/28/2024 PRESENTED BY MS. SAYALI POWAR ICH 12
Total Quality Management (TQM):
Definition, elements, philosophies
.
3.Armand V Feigenbaum:
• He was the originator of the term “Total Quality
Control” .
• He believed that significant quality improvement
could be achieved by the participation of
everyone in the organization.
• He believed that the goal of Quality
improvement was to reduce the total cost of
quality to as low a percentage as possible.

13. 4/28/2024 PRESENTED BY MS. SAYALI POWAR ICH 13
Total Quality Management (TQM):
Definition, elements, philosophies
.
4.Philip Crosby:
He was a businessman and Author who contributed to
management theory and quality management practices.
His approach revolves around the zero defects program.
Philosophy: Quality means conformance to requirements
not elegance There is no such thing as quality problem
There is no such things as the economics of quality. It is
always cheaper to do the job right the first time. The only
performance measure is the cost of the quality The only
performance standard is zero defects

14. 4/28/2024 PRESENTED BY MS. SAYALI POWAR ICH 14
Total Quality Management (TQM):
Definition, elements, philosophies
.
4.Philip Crosby:
14 Steps to Quality are:

15. 4/28/2024 PRESENTED BY MS. SAYALI POWAR ICH 15
Total Quality Management (TQM):
Definition, elements, philosophies
.
4.Philip Crosby:
14 Steps to Quality are:

16. 4/28/2024 PRESENTED BY MS. SAYALI POWAR ICH 16
UNIT 1
• Quality Assurance and Quality Management concepts: Definition and
concept of Quality control, Quality assurance and GMP
• Total Quality Management (TQM): Definition, elements,
philosophies
• ICH Guidelines: purpose, participants, process of harmonization,
Brief overview of QSEM, with special emphasis on Q-series
guidelines, ICH stability testing guidelines
• Quality by design (QbD): Definition, overview, elements of QbD
program, tools
• ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for
registration
• NABL accreditation : Principles and procedures

17. 4/28/2024 PRESENTED BY MS. SAYALI POWAR ICH 17