Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.

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VALIDATION PROTOCOLVALIDATION PROTOCOL

2. CONTENTS
• Introduction
• Validation Protocol
• Outline of validation protocol
• Format of validation protocol
• Master validation protocol
• Qualification
• Cleaning validation protocol
• Conclusion
• References
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3. What is Validation
• Defination
Validation is a documented program that provides high degree of
assurance that a specific process, method or system consistently
produces a result meeting pre-determined acceptance criteria.
• Need of validation
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4. • Site validation committee
• Manufacturing department
• Quality assurance
• Quality control
• Research and development
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5. • Manager production
• Quality control manager
• Maintenance manager
• Production manager
• Quality assurance manager
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The documentation resulting from validation may be
divided into two categories
• Protocols
• Final validation Reports

7. • The validation protocol is defined as the experimental
plan that design thoroughly the validation programme.
• A written plan stating how validation will be conducted,
including test parameters, product characteristics,
production and packaging equipment, and decision points
on what constitutes acceptable test results
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Validation ProtocolValidation Protocol1,41,4

8. Validation protocol contain two sections
• Procedure
• Form
In the case where a protocol is change or modified after
its approval, appropriate reasoning for such a change
must be documented.
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9. • Scope
• Objective
• Description of process
• Identification of Critical parameters
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10. • Description of analytical method
• Documentation
• Conclusion
• Approval
• Final validation report
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Cont…Cont…

11. • Title
• Objective & Scope
• Responsibility
• Protocol Approval
• Validation Team
• Product Composition
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12. • Process Flow Chart
• Manufacturing Process
• Review of Equipments
• Review of Raw Materials
• Review of Analytical records
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13. • Identification of process
• Objective and measurable criteria
• Duration of the validation
• Identification and quality of system
• Identification of various test
Protocol developmentProtocol development

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15. The Master Validation Protocol is the outline of the
validation
• Identifies which items are subjects to validation
• It specifies responsibilities for validation
procedures and helps to plan required activity
• What is the qualification criteria for particular
system

16. Qualification is defined as the “action of proving that
any premises, systems and items of equipment work
correctly and actually lead to the expected results.”
The qualification protocol that provides details about
system , scope, test procedure, and acceptance criteria
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17. • Purpose
Give a clear and simple statement of Objectives of
qualification system
• Scope
The scope to indicate what equipment is being qualified
• Equipment Description
Simple description of the Equipment

18. • Responsibilities
Identify the responsibility of individual involve
approval of protocol
• Specification
Defining the full range of operating parameter like
temp, pressure ,time etc
• Conclusion
To summarize all test result performed in validation
of any equipment
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19. • Specification of requirements for facilities, plants and
equipment, mainly in connection with modification
of equipment
• Design Qualification for setting functional and
performance or operational specifications
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20. • Verifies that the correct equipment has been received
and installed as per plan and protocol
• Verifies that equipment has been properly installed
and calibrated including connections to utilities.
• Documented records for the installation
The supplier and manufacturer
System or equipment name, model and serial number
Date of installation relevant procedures and certificates
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21. • The equipment must be work according to approval
plans for testing procedures
• Systems and equipment should operate correctly
• Verifies that the equipment operates consistently
within established limits and tolerances over the
defined operating ranges.
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22. • It verifies that performance of critical utility system or
process
• Assurance that the process continues to comply with
established requirements.
• Performance Qualification (PQ) for testing that the
system consistently performs as intended for the
selected application.
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23. Re-validation is required when the operating
equipment or system has been changed in some
way.
It is carried out when:
The transfer of product from one plan to another
Computer systems have been replaced
Changes in the process use in the validation
Critical items have been replaced or repaired.
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24. TABLE OF CONTENTSTABLE OF CONTENTS
• Objective
• Scope
• Responsibility and authority
• Reference of cleaning document
• Equipment to be cleaned
Common equipment
Cleaning procedure and cleaning equipment
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25. Selection of Worst case productSelection of Worst case product
• Evaluation of the product mix to select the worst
case product or marker product
Operator training
Cleaning limits selection criteria based on MAC approach
• Validation Plan
Worst-case conditions
Chemical and microbiological analytical methods
Acceptance criteria
• Sampling plan
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26. • The validation protocol should list the selected process
and control parameters
• The quality of validation and its report is directly
related to the quality of protocol
• The protocol is foundation of validation report
including the documentation part
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27. 1) Nash RA ,Wachter AH , Pharmacutical Process Validation,An
International 3rd
Edition ,Revised &Expanded,Indian special
edition,Informa Healthcare, 2011 ,volume 129. p 607-609
2) Carleton FJ. Validation of Solid Dosage Forms, Validation of
Pharmaceutical Processes, In Marcel Dekker, 3rd
Edition ,
Informa healthcare USA, p 310-315
3) Potdar MA. Pharmacutical Quality Assurance ,Nirali
Prakashan, 2nd
edition 2007,p8.8-8.20
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28. 4) Haider SI.Pharmacutical Master Validation Plan, The
Ultimate Guide to FDA, GMP, & GLP Complience,Indian
Special edition , Informa Healthcare ,p311
5) Berry IR. and Harpaz D., Validation of Active
Pharmaceutical Ingredients, CRC Press, 2nd
edition, p421-
425, 463-468
6) www.econ.com
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