UNIT 1 QUALITY ASSURANCE B. PHARMACY PART 2

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. 4/23/2024 Presented by Ms. Sayali Powar ICH 1 UNIT 1

2. 4/23/2024 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. 4/23/2024 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. Quality Assurance and Quality Management concepts: Definition and concept of Quality control, Quality assurance and GMP 4/23/2024 Presented by Ms. Sayali Powar ICH 4

5. 4/23/2024 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. 4/23/2024 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. 4/23/2024 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. 4/23/2024 Presented by Ms. Sayali Powar ICH 8 Total Quality Management (TQM): Definition, elements, philosophies

9. 4/23/2024 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. W. Edwards Deming Joseph M Juran Armand V Feigenbaum Philip Crosby Dr. W. Edwards Deming: (1900-1993) is considered to be Father of Modern Quality.

10. 4/23/2024 Presented by Ms. Sayali Powar ICH 10 Total Quality Management (TQM): Definition, elements, philosophies

11. 4/23/2024 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. 4/23/2024 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. 4/23/2024 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. 4/23/2024 Presented by Ms. Sayali Powar ICH 14 Total Quality Management (TQM): Definition, elements, philosophies  . 4.Philip Crosby: 14 Steps  to Quality are:

15. 4/23/2024 Presented by Ms. Sayali Powar ICH 15 Total Quality Management (TQM): Definition, elements, philosophies  . 4.Philip Crosby: 14 Steps  to Quality are:

16. 4/23/2024 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. 4/23/2024 Presented by Ms. Sayali Powar ICH 17