1. 1
CONCEPT OF VALIDATION
Presented By
Prashik s shimpi
(M. Pharma 2nd
Sem. )
DEPARTMENT OF QUALITY ASSURANCE
R.C. PATEL INSTITUTE OF PHARMACEUTICAL EDUCATION &
RESEARCH, SHIRPUR.

2. Contents:
 Introduction
 Terms and definitions
 Basic concepts of validation
 Need For validation
 Types of validation
 Importance of validation
 Scope of validation
 Reasons for validation
 Personnel-Validation Team Members
 Validation Protocol
 Validation Master Plan
 Validation Summary Report
 Advantages of validation
 Limitations of validation
 Conclusion
 References
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3. INTRODUCTION
Validation is defined as “A Documented
Programme which provides a high degree of
assurance that a specific process will consistently
produce ,a product meeting its pre-determined
specifications and quality attributes.
 Validation is the process of evaluating products or
analytical methods to ensure compliance with
products or cleaning method requirements
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4. As per WHO
 Validation means providing documented evidence that any procedure, process,
activity or system actually leads to the expected results.
As per ICH
 Validation of analytical method is the process by which it is established by laboratory
studies, which the performance characteristics of the method meet the requirements for
predetermined standard.
As per FDA
 Validation is establishing documented evidence, which provides a high degree of
assurance that a specific process will produce a product meeting its pre determined
specification & quality attributes.
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TERMS & DEFINITION

5. BASIC CONCEPTS OF VALIDATION
 Validation is a Systemic approach to identifying,
measuring, evaluating, documenting and re-
evaluating the critical steps in manufacturing
process that requires in control to ensure
reproducible final product:-
 The following three basic steps involved in
validation are as follows:
1) Establishment of specifications and performance
characteristics.
2) Selection of methodology, process and equipments
to ensure that the product meets specifications.
3) Final product testing by using validated analytical
methods in order to meet specifications.
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6. 6
NEED FOR VALIDATION
1.Basic requirement for the product Quality system.
2.Assures that every lot of each product that is released to
the market will consistently meet all the Quality
requirements.
3.Capable of achieving the intended results.

7. 7
 ProspectiveValidation
- validation takes place prior to actual production runs.
 ConcurrentValidation
- some cases validation may take place as product however is in production.
 RetrospectiveValidation
- past production runs may be used to provide validation data.
o Revalidation
• Periodic revalidation may be necessary depending on the criticality of
the equipment
 Changes need to be evaluated for their impact on validation
 Deviations from specifications may require revalidation
 Revalidation spelled out in MasterValidation Plan
TYPES OF VALIDATION

8. IMPORTANCE OF VALIDATION
 Reduction of quality costs
 Process optimization
 Assurance of quality
 safety
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9. SCOPE OF VALIDATION
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• Analytical test Methods
• Instrument Calibration
• Process Utility Services
• Raw Materials
• Packaging Materials
• Equipment
• Facilities
• Manufacturing operations
• Product Design
• Cleaning
• Operators

10. REASONS FOR VALIDATION
 Customer satisfaction: Non-conforming product can lead to lost customers.
 Customer Mandated: Provision for securing new business.
 Product liability: Conformance to product specifications must be maintained.
 Reduced production costs: PV leads to reduced inspections, testing, scrap and
rework. Shifts costs from production to prevention.
 Supports improvements: Testing data can be used to support improvements in the
process or the development of the next generation of the process.
 Regulatory requirement
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11. PERSONNEL- VALIDATION TEAM MEMBERS
Quality Assurance
Engineering
Manufacturing
Other disciplines may be involved depending
on the product and process:
laboratory, technical services
research and development, regulatory affairs
clinical
chemical engineering
purchasing/planning
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12. Validation Protocol
 Specific protocols that provide detailed information on what
is to be validated.
 Validation Protocols consist of:
 A description of the process, equipment, or method to be
validated.
 A description of the validation method.
 A description of the sampling procedure including the kind
and number of samples.
 Acceptance criteria for test results.
 Schedule or criteria for revalidation.
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13. Validation Master Plan
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• Provides the roadmap for conducting validations.
• Establishes criticality of the process.
• Defines the validation approach.
• Documents rationale for decisions to “not validate”.
• Provides documented evidence of the validation
• Provides an easy to follow trail to locate relevant validation documents and test data.
• Establishes requirements for process changes.
The VMP provides a summary of the company’s philosophy,
policy, intentions and approach to validation.

14. Validation Summary Report
 VSR is a controlled document which lists all current validation
documentation to demonstrate that processes are validated and
specifies any revalidation requirements.
 Each VSR document number is referenced on the Process
Validation Master Plan, for ease of document retrieval.
 The VSR contains:
• Process title
• Applicable uncontrolled documentation
• List of all validation documentation
• Revalidation requirements
• Recurring validation requirements
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15. Advantages of validation
 During the process the knowledge of process increases.
 Assures the repeatability of the process.
 Assures the fluency of production.
 Assures that the product is continuously according to the marketing
authorisation.
 Decreases the risk of the manufacturing problems.
 Decreases the expenses caused by the failures in production.
 Decreases the risks of failing in GMP.
 Decreases the expenses of the every day production even though the
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16. Limitations Of Validation
Non Availability of competent people
,improper attitude of people , facilities and
equipment.
Inadequate technology.
A phenomenon of change, perfection
,environmental adaption and transition serves
as the limitation of validation.
Cost of validation.
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17. Conclusion
VALIDATION
 A quality tool that makes lot of sense.
 A prevention based activity important part of
quality building process.
 Expensive in the beginning later will "save the
money back“.
 In danger of becoming overwhelming .
 Risk-based assessment of what needs to be
validated or verified.
 The process must be under control/validation as
such does not improve the process.
 Validation - Logical entity: protocol + procedure
+ report .
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18. www.fda.gov/cdrh/qsr/intro.html
www.fda.gov/cdrh/comp/guidance/938.html
http://www.fda.gov/cder/guidance/5667fnl.do
c
 www.fda.gov/cder/guidance/pv.htm
www.fda.gov/cdrh/ode/3751.html
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List Of Websites

19.  Pharmaceutical Process Validation, 3rd Ed. Edited by Robert Nash and
Alfred Wachter, Marcel Decker, 2003. ISBN 082470838-5
 Validation Standard Operating Procedures: A step by Step Guide
for Achieving Compliance in the Pharmaceutical, Medical Device,
and Biotech Industries, Syed Imtiaz Haider, St. Lucie Press, 2002.
ISBN 1574443313.
 Good Manufacturing Practices for Pharmaceuticals: A Plan for Total
Quality Control From Manufacturer to Consumer, Sidney J. Willig. Marcel
Decker, 2000. ISBN 0824704258
 M.N.Potdar,Pharmaceutical Qualitry Assurance, Nirali
Prakashan,First Edition,8.28

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