Quality assurance

1. QUALITY ASSURANCE

2. INTRODUCTION
 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 ( International Organization for
Standardization):
“All those planned and systematic activities implemented to
provide adequate confidence that an entity will fulfill
requirements for quality.”

3. CONCEPT OF QUALITY ASSURANCE
 Quality assurance is an organizations commitment, that
the service (test, analysis or product) it offers meets the
accepted quality standard, which is helpful to increase
the customer confidence and organization credibility. It
improves the work process and technical expertise so,
the organization can better compete with other
organizations.
 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 Assurance
Provide high quality product to consumer.
Prevent or reduce the number of recalls,
returned products and defective products
entering the market place.
Disadvantages of Quality Assurance
Perfection is set of mind.
It always gives a limit.

5. VALIDATION
Validation is a quality assurance technique.
Validation is an act of demonstrating that a
procedure, process, and activity will
consistently lead to the expected results.
Establishing documented evidence that
provides a high degree of assurance that a
specific process will consistently produce a
product meeting its pre-determined
specifications and quality attributes. (FDA
1987).

6. VALIDATION
It is a requirement for Good Manufacturing Practices and
other regulatory requirements.
There are a number of stages (phases) in performing a
validation program which are widely accepted as
conforming to best validation practice, namely the stages
of
1. Design qualification (DQ),
2. Installation qualification (IQ),
3. Operational qualification (OQ) and
4. Performance qualification (PQ)

7.  Design Qualification (DQ)- The design qualification
is focused on ensuring there is documented
verification that the proposed design is suitable for
the intended purpose. Design qualification is the first
step of the validation.
 Installation Qualification (IQ) - The installation
qualification ensures that every equipment along
with all of its components have been installed
appropriately and in accordance with manufacturer’s
guideline presented in the equipment manual.
 Operational Qualification (OQ) - Demonstrates that
all aspects of the process or equipment are
operating correctly.
 Performance Qualification (PQ) - Demonstrates
that the process or equipment performs as intended
in a consistent manner over time.

8. 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
 “Sigma” is Greek word used in statistics for S.D. that
measures how far a given process deviates from
Standard one.

9. WHAT IS SIX SIGMA?
 Six Sigma is a measurement-based strategy for process
improvement. It’s a methodology, which aims at
improving process and increasing customer satisfaction
(Both internal & external). The concept behind this
approach is to reduce the variation in processes. This
reduction leads to consistent and desired outcomes from
processes.
 Goal:
The goal of six sigma is to Continuous process
improvement with low defects.