This document discusses concepts of quality assurance in the pharmaceutical industry. It begins with definitions of quality assurance from WHO and ISO. It then discusses the concept of quality assurance, covering all aspects that influence drug quality. Advantages include ensuring high quality drugs while disadvantages include perfection being difficult. Quality assurance tools discussed include total quality management, quality control systems, documentation, validation, and Six Sigma methodology. Total quality management aims to continuously improve quality through participation at all levels. Quality control systems involve qualified staff and standardized procedures. Documentation and validation are important for defining systems and ensuring quality. Six Sigma uses a data-driven approach to reduce defects and improve processes.

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”

18. Importance of Validation1,2,3
 Reduction of Quality costs
 Process Optimization
 Assurance of quality
 Safety

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%.

24. Performance Standards
2
3
4
5
6
308537
66807
6210
233
3.4
 PPM
69.1%
93.3%
99.38%
99.977%
99.9997%
Yield
Process
performance
Defects per
million
Long term
yield
Current standard
World Class

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

29. Web Reference
l. http://www.pharmainfo.net/equipment-validation-
articles/laboratory-equipment-qualification
ll. http://www.sei.cum.edu/sigma