scope and typed of validation

1. Presented By..
MISS. Nikita D. Gidde
M. Pharm. (SEM – I)
Dept. of Pharmaceutics
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Rajarambapu College of Pharmacy,
Kasegaon.

2.  Introduction
 Need of Validation
 Scope of Validation
 Types of Validation
 Conclusion
 References
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3.  The concept of validation was first proposed by Food
and Drug Administration(FDA)
 Validation is "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.
 This is to maintain and assure a higher degree of
quality of food and drug products.
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4.  Customer satisfaction
 Customer mandated
 Product liability
 Control production cost
 The development of the next generation
 Safety
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5.  Analytical Test Methods
 Instrument Calibrations
 Process Utility Services
 Raw Material
 Equipment
 Facilities
 Product Design
 Cleaning
 Operators
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6. The major types of Validation :
A. Process validation
B. Cleaning validation
C. Equipment validation
D. Validation of analytical methods
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7. Definition
As per FDA Nov.2008,‘The collection of data
from the process design stage throughout
production, which establishes scientific evidence
that a process is capable of consistently delivering
quality products.
Process validation life cycle:
Stage 1. Process design
Stage 2. Process qualification
Stage 3. Continued process verification
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8. a) Prospective validation.
b) Retrospective validation.
c) Concurrent validation.
d) Revalidation.
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10. Definition:
“A process of attaining and documenting sufficient evidence
to give reasonable assurance, given the current state of
Science and Technology, that the cleaning process under
consideration does, and / or will do, what it purpoes to do.”
Objective..
To minimize cross contamination.
To determine efficiency of cleaning process.
To do troubleshooting in case problem identified in the
cleaning process and give suggestions to improve the
process.
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11. Source of contamination:
Cross contamination product of one product into
another.
Product contamination by a foreign material.
Microbial contamination.
Cleaning methods:
Manual cleaning method.
Semi automated procedures.
Fully automated procedures.
Factors Influencing Cleaning validation :
Product.
Equipment.
Facilities.
Cleaning methods.
Cleaning agents.
Sampling.
Testing, Limits, and acceptance criteria.
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12. Definition
As per FDA, May 1987,‘Action of proving that any
equipment works correctly and leads to the expected result
is equipment
It is not a single step activity but instead result from many
discrete activities.
Steps involved..
User requirement specification
Design qualification
Installation qualifications
Operational qualifications
Performance qualification
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13. Definition :
“The process by, which it is established, by
laboratory studies, that the performance
characteristics of the method meet the
requirements for the intended analytical
application”.
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14.  Validation has been proven assurance for the
process efficiency and sturdiness and it is the full
fledged quality attributing tool for the
pharmaceutical industries.
 Validation is the commonest word in the areas of
drug development, manufacturing and
specification of finished products. It also renders
reduction in the cost linked with process
monitoring, sampling and testing.
 Apart from all the consistency and reliability of a
validated process to produce a quality product is
the very important for an industry
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