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Int.J.Inv.Pharm.Sci.,2(5)2014;865-871
www.ijips.net
ABSTRACT: In this review article, it has been tried to focus on familiarizing ideas of validation, its types and applications in different sectors of pharmaceutical
industry. It has also been tried to integrate the information why and how validation has become integral and inseparable part of GMPs. Quality, identity, purity,
stability, strength, safety and efficacy of the drug product are prime requirement of GMPs and cGMPs. These are the parameters that every drug should satisfy to
ensure that they are consistently produced and controlled to quality standards, appropriate to their intended use as required by the product specification. Validation
is the action of proving effectiveness by means of proper documentation, and accomplished through proper implementation of norms of GMP and cGMPs
through mutual collaboration of each individuals involved in the manufacturing of medicinal products following a set of protocols. In order to build up quality in
products, every pharmaceutical industry should put their prime focus in validation.
Keywords: Good Manufacturing Practices, Approaches in validation, Quality.
INTRODUCTION:
st
its grasp all over the world, global health sector is also advancing
Why validation?
the product.
trend
valid [1].
toward
harmonization
of
requirements
worldwide.
validation are:[4]
throughput
and
improved
production
efficiency
Increased
Rapid automation
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been easy with the help of validation decision tree. The model of
established parameters
decision tree
[5]
A
Is process Output
Verifiable
B
Is Verification
Sufficient & Cost
Effective
Yes
C
Verify & Control
the Process
Yes
No
No
E
Redesign Product
and/or Process
D
Validate
Scopes of validation:
below:
A.
ensured that the equipments comply with the specifications and all
appropriately controlled.
B.
C.
D.
E.
a)
Evidence
obtained
[6]
through
testing
process
i.e.
Analysis
of
accumulated
data
i.e.
retrospective
validation.
a)
day basis.
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b)
d)
primary packaging.
specifications.
Validation committee:
the
or
process
environment,
quality characteristics
[8]
whether
intentionally
[10]
.Specific
below.
Responsibility or function
Engineering
They install, qualify, and certify plant, facilities, equipment and support system.
Development
They design, optimize and qualify manufacturing process within design limits, specifications,
or requirements for products.
Manufacturing
They operate and maintain plant, facilities, equipments, support systems, and various
manufacturing process within its requirements and specifications.
Quality Assurance
1.
2.
3.
4.
Installation
and
operational
blueprints or drawings.
5.
Qualification reports
a.
Sub-process 1
b.
Purpose
c.
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qualifications,
including
d.
e.
Reporting function
Process Validation:
f.
g.
Test data
h.
Summary of results
i.
j.
Sub-process 2 (repeat)
Guidelines,
process
validation
is
6.
7.
batches.
quality characteristics.
requalification requirements).
Certification (approval).
8.
9.
Elements of validation:
scale-up activities.
1.
Design qualification:
2.
3.
Production
processes
(fermentation,
bulk
production,
Installation qualification:
Operational qualification:
Performance qualification:
product acceptability.
4.
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are readily available for a stipulated period after the system has
3.
4.
5.
6.
7.
8.
9.
1.
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Equipment Validation:
Equipment
validation
predefined
comprehensively
specifications
and
establishes
operational
in
[16]
attributes
Packaging Validation:
involves
operation,
qualifying
the
design,
installation,
down time, rejects and errors. Its crucial to guarantee that the
during transport and storage until the time of use. Some tests that
[17]
Vendor Validation:
sealing strength test, vacuum test, and accelerated aging test [22].
Whenever any system is set for its validation to verify that it meets
[18]
. It involves
Personnel Validation:
[20,21]
. It is used to
interferon, etc.
Environment Validation:
Change Control:
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[9]
[10]
[11]
[12]
[13]
[14]
[15]
planning,
rationale,
risk
assessment,
evaluation,
[2]
[3]
[4]
[5]
[6]
[7]
[8]
Page | 871
[16]
http://www.askaboutvalidation.com/52442-definingcalibration-validation-of-equipment.
[17]
[18]
http://www.gmp-compliance.org/eca_news_355.html
[19]
[20]
[21]
[22]