2. QUALITY ASSURANCE ???
• WHAT IS Q.A ???
• WHAT DO YOU MEAN BY QUALITY PRODUCT IS??
• NEED OF QUALITY ASSURANCE??
• WHAT ARE THE KEY INGREDIENTS TO ACHIVE THE
QUALITY ASSURANCE???
4. 4
Major Risks in Pharmaceutical
Production
• Contamination of products (microbial, particulate
or other)
• Insufficient active ingredient
• Excess active ingredient
• Poor quality raw materials
• Poor formulation practices
• Incorrect labels on containers
5. 5
Main objectives of QA :
To achieve product realization
Establish and maintain a state of control, and
Facilitate continual improvement
Pharmaceutical quality system should include the
following elements -
Process performance and product quality monitoring
Corrective and preventive actions
Change management and management review
Key performance indicators should be identified and used to monitor
effectiveness of processes.
OBJECTIVES OF Q.A
7. QC
GMP
QA
7
Is that part of Quality
Assurance aimed at
ensuring that products are
consistently manufactured
and examine within
constant quality system
GMP
Is that part of GMP concerned
with sampling, specification &
testing, documentation &
release procedures which
ensure that the necessary &
relevant tests are performed &
the product is released for use
only after ascertaining it’s
quality
QC
QUALITY MANGEMENT
8. KEY FACYORS TO ACHIVE QM:
1. CUSTOMER FOCOUS
2. LEADERSHIP
3. INVOLMENT OF PEOPLE
4. PROCESS APPROCHE
5. SYSTEM APPROCH TO MANGEMENT
6. CONTINEOUS IMPROVEMENT.
7. EFFECTIVE DECISION MAKING
8. RELATIONSHIP MAINTAINANCE
10. QUALITY APPROCHES
CUSTOM
TQM
• WORLDWIDE APPLICATION
• BASED ON CUSTOMIZED STANDARD
I S O
• WORLDWIDE APPLICATION
• BASED ON INTERNATIONAL STANDARD WITH
ACCREDITED NATIONAL AND INTERNATIONAL
CERTIFICATION
MBNQA
•NATIONAL APPLICATION
•BASED ON NATIONAL STANDARD
ALL THREE ARE DESIGEND TO ENCOMPASS ALL OF THE
ORGANIZATION’S CORE COMPETENCIES
11. ISO QUALITY STANDARD
• The purpose of these standards is to simplify the
things for organisation and to assist the organization
to implement and operate effective quality
management system.
REQUIRMEN
TS
That help to
achieve customer
satisfaction
That assure that
the quality system
are constantly
implemented and
verify
For practice that
measure the
effectiveness
That support the
continuous
improvement to
meet customer
needs.
12. ISO FAMILY
-
Appreciation
of
fundamental
concept of
QMS
-Guidelines
for selection
and use
ISO
9000 - Used for
external quality
assurance
-Companies that
design & develop
their own
products
-Provide the
requirments
ISO
9001
QA in
production
,installation
and servicing.
For
subcontractor
ISO
9002
It is
applicable
for the
testing of
laboratorie
s &
equipment
distributio
n
ISO
9003
Guideline for
quality
management
planning ,
implementation
and
performance
improvement
ISO
9004
