1. • PRESENTD BY :-
• PATIL PRANJAY SADASHIV.
• FIRST YEAR M.PHARM.
• DEPARTMENT OF QUALITY ASSURANCE.
H. R. Patel Institute of Pharmaceutical Education
and Research, Shirpur
THE CONCEPT OF QUALITY ASSURANCE,
TOOLS & TECHNIQUES
2. Introduction1
According to WHO (World Health Organization):
“QA is the activity of providing evidence needed to
establish confidence among all concerned that quality
related activities are being performed effectively.”
According to ISO:
“All those planned and systematic activities
implemented to provide adequate confidence that an entity
will fulfill requirements for quality.”
3. Concept of Quality Assurance1
Quality assurance is wide ranging concept which covers all
matters which individually or collectively influence the
quality of the product. It is sum of total organized
arrangements made with the object of ensuring that
medicinal products are of the quality required for their
intended use.
Quality assurance is related to all operations including
manufacturing,testing and records.
4. Advantages of Quality Assurance1
Provide high quality drug product to patients and
prescribers.
Prevent or reduce the number of recalls , returned or
salvaged products and defective products entering the
market place.
To help in getting quality by design.
5. Disadvantages of Quality Assurance1
Perfection is set of mind.
It always gives a limit.
We must see, what benefits the ultimate customer is going to
get.
6. Quality Assurance tools and technique1,2,4,ll
List of Tools
Total Quality Management
Quality Control System
Documentation
Validation
Quality Assurance technique
Six Sigma Methodology
7. Total Quality Management4
Definition:
TQM is an approach for continuously improving the quality of
goods and services delivered through the participation of all levels
and functions of the organization.
TQM is an intensive, long term efforts to transform all parts of the
organization in order to produce the best product and service
possible to meet customer’s need.
8. What is Total Quality Management?
Management Concept
Do things right the first time.
Customer.
THE CUSTOMER
Review &
Monitoring
Specification &
planning
Delivery
Market research
9. Factors affecting TQM
Market
Money
Management
Men
Motivation
Materials
Machines
Max Latest information
10. Benefits of TQM
Higher customer satisfaction
Better efficiency of operations
More productivity & profit
Less wastage costs
Less Inspection costs
More market share
Spread of happiness & prosperity
Better quality of life for all.
11. Effects of poor Quality
Low customer satisfaction
Low productivity, sales & profit
Low morale
More re-work, material & labor costs
High inspection costs
Higher inventory costs
Greater waste of material
12. Quality control system1
Qualified and experience staff
Area divided into chemical, instrumentation, microbiological and
biological testing
Adequate area for keeping reference samples
SOPs for sampling, inspecting and testing of raw materials, finished
products etc
13. Cont...
No batch release without certification
Stability studies of all products
Calibrated and validated instruments
Product specification approved and maintained by q/c.
Pharmacopoeia ,reference standards, working standards
shall be available.
14. Difference of QC and QA1,4
QC
QC is that part of GMP which
is concerned with sampling,
specifications, testing and
with in the organization,
documentation ,and release
procedures which ensure that
the necessary and relevant
tests are carried out
Operational laboratory
techniques and activities used
to fulfill the requirement of
Quality
QC is lab based
QA
Q.A is sum total of
organized arrangement
made with the object of
ensuring that product will
be of the Quality required
by their intended use.
All those planned or
systematic actions
necessary to provide
adequate confidence that a
product will satisfy the
requirements for quality
QA is company based.
15. Documentation1,4
Documentation means all the written production
procedures, instructions, and records, quality control
procedures and recorded test results involved in the
manufacture of the medicinal product.
16. Purpose Of Documentation
1. To define the system of control.
2. To reduce the risk of error which introduced by verbal
communication
3. To permit investigations
4. Tracing of defective products
17. Validation2,3
Introduction
Definition
March 29 ,1983 it was the only official definition of
process validation is “A documented programmed , which
provides a high degree of assurance that a specific process
will consistently produce, a product meeting its pre
determined specifications and quality attributes”
19. Types of validation1,2,3
Validation of Buildings and Facilities
Validation of Equipment
Process Validation
Cleaning Validation
Validation of Analytical Methods
Validation of Computer Systems
Validation of Specific Dosage Forms
20. Six sigma methodology4,ll
History
Sigma, as a mathematical term was coined by
Walter Stewart in 1920.
The first commercial application is credited to
Motorola. Motorola developed this new
standard and created a methodology for its
implementation.
In pharma companies Pfizer, Merck, GSK, Dr.
Reddy, Johnson & Johnson etc. adopted this
method for quality improvement
21. What is six sigma?
Is highly discipline approach.
It is based on statistical work.
“Sigma” is Greek word used in statistics for S.D.
that measures how far a given process deviates from
Standard one.
Six Sigma generates a maximum defect probability
of 3.4 parts per million.
22. Six Sigma Methodology (DMAIC)
Define
Measure
Analyze
Control
Improve
Define
Measure
Analyze
Improve
Control
23. Six Sigma – Case studyll
A dabbawala is a person in the Indian city of Mumbai whose job is to carry and
deliver freshly made food from home in lunch boxes to office workers.
Dabbawalas pick up 175,000 lunches from homes and deliver to their customers
everyday.
Accuracy rating is 99.99%.
25. Roles required for implementation
Levels of certification,
Master Black Belts,
A Master Black Belt takes on a leadership roles as keeper of the Six Sigma process, advisor to
executives or business unit managers, and leverages, his/her skills with projects that are led by
black belts and green belts. Frequently, master black belts report directly to senior executives or
business unit managers. A master black belt has successfully led ten or more teams through
complex Six Sigma projects.
Black Belts,
A Six Sigma Black Belt is a full-time change agent and improvement leader who may not be an
expert in the process under study
Green belts,
A Six Sigma Green Belt is an individual who works on projects part-time (25%), either as a team
member for complex projects, or as a project leader for simpler projects.
26. Conclusion
Quality is a journey,not a destination
A prevention based activity important part of quality
building process.
Expensive in the beginning later will "save the money
back“.
Management of Quality is essential.
Training & Development of employees
27. References
1. Potdar A. M.; Pharmaceutical Quality Assurance,1st ed.
Published by Nirali Prakashan, 2006.P. 5.1-5.58 , 8.1-8.108
2. Robert Nash and Alfred Wachter; Pharmaceutical Process
Validation, 3rd Ed. Edited by Marcel Decker, 2003. P 749-789
3. , Syed Imtiaz Haider; Validation Standard Operating
Procedures: A step by Step Guide for Achieving Compliance in
the Pharmaceutical, Medical Device, and Biotech Industries, by
St. Lucie Press, 2002. P.95-110
28. Continue..
4. C. B. Gupta “Management Theory and Practice” 11th Edition,by
Sultan Chand and Sons Educational Publishers, New Delhi, P.
52.11-52.24