QA tools & techniques.

1. PRESENTED BY
PRASHIK S SHIMPI
M.PHARM(2nd
SEM)
DEPARTMENT OF PHARMACEUTICS & QUALITY ASSURANCE
GUIDIDED BY
Dr..H.S.MAHAJAN
(Dept of pharmaceutics & Quality Assurance)
R.C Patel Institute of Pharmaceutical Education
&Research center, Shirpur

2. Contents
 Introduction
 Advantage of Quality Assurance
 Disadvantage of Quality Assurance
 Lists of Tools and Technique
 Description of Tools and Technique
 Conclusion
 References

3. What is Quality Assurance?
 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.”

4. Advantages of Quality Assurance
 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 handle many types of changes to facilitate, equipment
and processes without the need for a regulatory
submission.
 To help in getting quality by design.

5. Disadvantages of Quality Assurance
 Perfection is set of mind and not reality.
 It means stoppage of improvement and hence nothing can
remain perfect.
 It always gives a limit.
 We must be see what benefit the ultimate customer is going
to get.

6. Quality Assurance tools and technique
that are to be used when performing
quality assurance activities
 List of Tools
 Total quality management
 Quality Control System
 Documentation
 Validation
 Quality Assurance technique
 Six sigma methodology

7. Total Quality Management
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. Principle
 Zero defects
 Eliminate causes of poor quality
 Drive out fear
 Leadership
 Continuous improvement

10. Advantages
 Improved Quality
 Employee Participation
 Team Work
 Internal & External Customer
Satisfaction
 Productivity ,Communication

11. Problems
 Data’s & Facts For Effective Decisions
 Internal & External Customers-Dissatisfaction
 Empowerment & Teamwork
 Continuous Improvement
 Top management commitment
 Changing Organization Culture
 Improper planning
 Continuous Training & Education

12. Quality control system
 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
 Authorized and dated specifications for all materials

13. cont
 No batch release without certification.
 Reference/retained samples in double of the required
quantities
 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 QA
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
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. Documentation
 Definition
Document 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. Stage of Product Development
 Drug discovery
 Compound
identification
 Pre-clinical studies for
API
 Clinical studies for API
 Pre-formulation
 Formulation
 Pilot plant scale-up
technique
 Stability studies
 Pre-clinical studies for
dosage form
 Application for IND
 Clinical trial
 FDA approval for
marketing
 Post marketing
surveillance

18. Validation

19. Scope of validation
 Analytical Test Methods
 Instrument Calibration
 Process Utility services
 Raw materials
 Packaging materials
 Equipment
 Facilities
 Manufacturing operations
 Product Design
 Cleaning
 Operators

20. Importance of Validation

21. Types of validation
 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

22. Six sigma methodology
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

23. 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
Six Sigma generates a maximum defect probability
of 3.4 parts per million.

24. Approaches
DMAIC
 Design
 Measure
 Analyze
 Improve
 Control
DMADV
 Define
 Measure
 Analyze
 Design
 Verify

25.  WHY Six Sigma? Satisfaction of customers
 WHO does it? Structured top-down initiative
 WHAT is it? Statistical thinking using data to
combat variation in processes
 WHERE is it? Standardized framework of“
DMAIC”
 HOW is it done? Software packages such as
Minitab for information analysis
 WHEN is it done? Sustained effort via project

26. Roles required for implementation
Executive leadership
 Champions,
 Master Black Belts ,
 Black Belts,
Green belts,

27. Conclusion
 A quality tool that makes lot of sense.
 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

28. References
 Pharmaceutical Process Validation, 3rd Ed. Edited by Robert Nash
and Alfred Wachter, Marcel Decker, 2003. ISBN 082470838-5
 Pharmaceutical Process Validation, 3rd Ed. Edited by Robert Nash
and Alfred Wachter, Marcel Decker, 2003. ISBN 082470838-5
 Validation Standard Operating Procedures: A step by Step Guide for
Achieving Compliance in the Pharmaceutical, Medical Device, and
Biotech Industries, Syed Imtiaz Haider, St. Lucie Press, 2002. ISBN
1574443313.
 Tim Hannagan , “Management concept and Practices” P.N. 160-170.
 Weihrich Koontz “Management A Global Perspective” 10th Edition,
P.N. 650-

29.  C. B. Gupta “Management Theory and Practice”
P.N.52.11-52.24
 A.Lakshmana Rao, M. Bharani “Total
QualityManagement
 The Need Of New Era” , Indian Journal of
Pharmaceutical
Education & Research , Dec-05 ,Vol-39, Issue- 4,

30. Thank You