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Everything

You Ever Wanted to KnowAbout Process Validation

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Process ValidationIt is a documented program which provides a high

degree of assurance that a specific manufacturing

process will consistently deliver a product meeting

its pre-determined specifications and uality

attributes! characteristics"

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#ypes of Process Validation

Prospective Validation$oncurrent Validation

%etrospective Validation

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Prospective Validation

Process validation that is completed and approvedprior to the commercial distribution of the product

or product made under a revised manufacturing

process& where the revisions may affect the

product's characteristics"

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$oncurrent Validation

Process validation where product is distributed

commercially prior to the completion of the

validation study"

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%etrospective Validation

Process validation for a product already in

distribution based on accumulated production&

testing and control data"

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Validation Protocol

A written and approved e(perimental plan

stating how validation will be conducted&including test parameters& product

characteristics& production euipment and

decision points on what constitutesacceptable test results"

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$ritical Parameters

#hose process parameters that have been identifiedas important to produce product that meets its pre-

determined specifications and uality attributes!

characteristics"

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%e-validation

A complete or partial repetition of a protocol study

or a new protocol study for a given manufacturing

process due to a process change"

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$hange $ontrol

A monitoring system by which ualified

representatives of various disciplines review

proposed or actual changes that may affect the

validation status and propose re-validation to

maintain such status"

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$ritical )uality Attribute

A measurable characteristic of the material that

affects its suitability for its intended use"

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)uality *oalsProcess validation is a +ey element in assuring that the

following uality goals are met,

)uality& safety and effectiveness must be designed andbuilt into the product"

)uality can not be inspected or tested into the product"

Each step of the manufacturing process must be controlledto ma(imie the probability that the product meets all

uality and design specifications"

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Pre-%euisitesAll ma.or euipment must have gone through

I)!/)!P)"All process critical utilities must be evaluated in

relation to the reuirements of the new process"All critical raw materials must be well

characteried"$leaning procedures must be validated prior to or

concurrently with process validation"

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Pre-%euisites 0$ontinued1

Analytical methods must be validated prior to

testing all validation samples"

All personnel training must be completed"

Validation protocol must be approved prior to

commencing process validation"

2ailure investigation and change control systems

must be in place"

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Validation 3trategy4ew product validations must include a minimum

of three consecutive& successful& full-scale batches"

$ritical process variables must be monitored&

documented and analyed"

3ampling and testing points must be clearly

defined in the protocol"

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Validation 3trategy 0$ontinued1

3ampling and testing must be performed for thecritical process steps in order to demonstrate

control throughout the process"Acceptance criteria must be established for all tests

deemed critical to the process"

All process validation studies must be conductedaccording to a pre-approved process validationprotocol"

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Process Validation ProtocolPurpose

3cope

%esponsibilities

Process description

2low diagramEuipment list

$ritical parameters

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Process Validation Protocol 0$ontinued1

3ampling plan

#esting procedures

Acceptance $riteria

Investigations& if any

%e-validation& if necessaryAppendi(!3upporting documents

Addenda

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2inal %eport%aw 5ata!3upporting 5ocumentation

#raining of /perators

3ummary

%ationale!$onclusions

5eviations!//3 Investigations%e-Validation& if necessary

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