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VALIDATION PROTOCOL VALIDATION PROTOCOL

CONTENTS• Introduction

• Validation Protocol

• Outline of validation protocol

• Format of validation protocol

• Master validation protocol

• Qualification

• Cleaning validation protocol

• Conclusion

• References2

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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• Site validation committee

• Manufacturing department

• Quality assurance

• Quality control

• Research and development

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• 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

• 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

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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• Scope

• Objective

• Description of process

• Identification of Critical parameters

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• Description of analytical method

• Documentation

• Conclusion

• Approval

• Final validation report

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Cont…Cont…

• Title 

• Objective & Scope 

• Responsibility

• Protocol Approval

• Validation Team 

• Product Composition  11

• Process Flow Chart 

• Manufacturing Process

• Review of Equipments   

• Review of Raw Materials

• Review of Analytical records

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• Identification of process

• Objective and measurable criteria • Duration of the validation

• Identification and quality of system

• Identification of various test

Protocol development Protocol development

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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

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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• 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

• 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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• 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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• 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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• 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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• 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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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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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  24

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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• 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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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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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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