Qa tools and techniques

QUALITY ASSURANCE,
TOOLS & TECHNIQUE
1
Mr. Sagar Kishor SavaleMr. Sagar Kishor Savale
Department of Pharmaceutics
avengersagar16@gmail.com
2015-016
Mr. Sagar Kishor SavaleMr. Sagar Kishor Savale
Department of Pharmaceutics
avengersagar16@gmail.com
2015-016
Department of Pharmacy (Pharmaceutics) | Sagar savale
Sagar Kishor Savale

Contents
Introduction
Definition of Quality Assurance
Concept of Quality Assurance
Advantage of Quality Assurance
Disadvantage of Quality Assurance
Lists of Tools and Technique
Description of Tools and Technique
Conclusion
References
2Sagar Kishor Savale

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.” 3Sagar Kishor Savale

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.

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.

Disadvantages of Quality Assurance1
Perfection is set of mind.
It always gives a limit.
We must be see what benefit the ultimate customer
is going to get.

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

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.

What is Total Quality Management?
 Management Concept
 Do things right the first time.
 Customer.
THE CUSTOMER
Review &
Monitoring
Specification &
planning
Delivery
Market research

Factors affecting TQM
 Market
 Money
 Management
 Men
 Motivation
 Materials
 Machines
 Latest information

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.

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

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

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.

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.

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.

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

Validation2,3

Importance of Validation1,2,3

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

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

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.

Six Sigma Methodology (DMAIC)
Define
Measure
Analyze
Control
Improve
Define
Measure
Analyze
Improve
Control

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%.

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

Roles required for implementation
 Master Black Belts ,
 Black Belts,
Green belts,

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

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
4. C. B. Gupta “Management Theory and Practice” 11th
Edition,by Sultan Chand and Sons Educational Publishers,
New Delhi, P. 52.11-52.24

Web Reference
l.
http://www.pharmainfo.net/equipment-validation-a
(assessment 2 Oct. 2016, time 5 pm)
ll. http://www.sei.cum.edu/sigma (assessment 5
Oct. 2016, time 7 pm)

Qa tools and techniques

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