Product and Process Validation Training

8/2/2019 Product and Process Validation Training

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Process Validation

Presentation

6/7/06

By Clay Anselmo

Rocky Mountain RAPS



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Learning ObjectivesUnderstand the purpose of process validation.

Understand the key components of a good processvalidation (IQ, OQ, PQ).

Understand how these elements and their definitions have

changed over the years.

Be able to categorize processes and determine the extentof validation required.

Understand documentation requirements for validationand the process for storage and retrieval of thesedocuments.



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Concepts and DefinitionsLet’s be perfectly clear!

Process Validation (QSR): Establishing by objective evidence

(documented) that a process consistently produces a result or product meeting its pre-determined specifications.

Design (Product) Validation: Establishing by objective evidence (documented) that device specifications conform with user needs and intended use(s).



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Concepts and DefinitionsVerification: Confirmation by examination and provision ofobjective evidence that specified requirements have beenfulfilled.

Prospective Validation: A validation that establishesdocumented evidence that a product or process conformsto its specifications prior to final release of the product orprocess.

Retrospective Validation: A validation that establishes

evidence that a product or process performs to itsspecifications based on a review and analysis of historicalperformance data.



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Concepts and DefinitionsInstallation Qualification (IQ):

Installation and Installation Conditions (electrical, air, water,

etc.)Calibration and Preventive Maintenance

Safety Features

Complete Documentation including equipment and software

Environmental Conditions

Training

Does NOT typically require statistically based sampling or data analysis



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Concepts and DefinitionsOperational Qualification (OQ):

Show equipment functionality over the range of specifications

Show equipment stability and capability in worst case conditions (considering all process inputs)

Equipment settings

Raw material

Supply variations (air, water, etc.)

Establishment of action and alert limits as appropriate Confirmation of failure modes

Uses valid statistical methods for analysis of data and variation


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Concepts and DefinitionsPerformance Qualification (PQ):

Demonstrate longer-term stability and capability of the

process under nominal conditions Evaluates acceptability of product against specification

Utilizes valid sampling and statistical techniques

Multiple Lots

Multiple Operators



Concepts and DefinitionsWHEN IS IT NECESSARY TO PERFORM VALIDATION?

21 CFR 820.75 – Where the results of a process cannot be fully verified by subsequent inspection and test, the

process shall be validated with a high degree of assurance…

ISO 13485:2003 – The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent

monitoring and measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.



GHTF Flow Chart



Concepts and DefinitionsWhat/When Processes Should be Validated?

End product tests that verify device conformance to specifications and requirements

When destructive testing is required to show product conformance to specification

When even state-of-the-art testing methods cannot demonstrate conformance to specification

Process capability is unknown or it is suspected that the process

is barely capable of meeting device specifications



Validation OverviewDefine product requirementsand specifications

Define processinputs/outputs andspecifications

Plan the validation process

Develop ProtocolsTest Method Verification / Validation

Measuring equipment suitability

(i.e. –

gage R&R)IQ – Installation Qualification

OQ – Operational Qualification

PQ – Performance Qualification

Execute Protocols

Compile and Analyze Data

Corrective Action and Re-execution as Necessary

Create / Approve FinalReport



Validation Planning ElementsWhy Create a Validation Plan

Allows quick overview of validation activities

Reduced approval cycle iteration Pre-Requisites

Clear Requirements/Specifications

Basic Test Methods (verified or validated)

Test Definition/DescriptionPlan should include a clear description of each set of tests to be performed

PurposePlan should contain the purpose of each set of tests



Validation Planning ElementsRequirements

Plan should briefly describe the requirements for each set

of tests and be traceable to product or process specifications

Acceptance CriteriaPlan should contain the general acceptance criteria for each set of tests or cross reference the location.

Analytical TechniquesDefine the method for analyzing data using commonly accepted statistical techniques.



Protocol Development All Validations should be executed per a formal,pre-approved protocol

Pre-approval is not a regulatory requirement, just a good practice

that prevents delays and re-executions.

Protocol format is OPTIONAL but must includethe following key sections:

Purpose / Background

Configuration of product or process

Material and Equipment (including Calibration data)

Sampling, Data Analysis Methods

Test Procedure

Clear Acceptance Criteria



Protocol Development Key Protocol Sections (cont.)

Data Sheets

Conclusions

Deviations

Revision History

Key PointsProvide background and justification for approach

Ensure test method is appropriate (verified or validated)

Protocol Review

Protocol Pre-Execution Approval



Validation CompletionExecution

Follow the protocol!

Note any deviations Use good documentation practices

Sign the data sheets

Collect equipment calibration information

Make sure training is documented



Validation CompletionFinal Report

May be an addition to protocol or a separate document

Summarize the results specifically related to each test or challenge

Document and justify your deviations

Deviations are not for changes to acceptance criteria

Document your data analysis

Reach formal conclusions regarding the overall outcome of the validation

Needs approval



Special ConsiderationsDeviations

Document all deviations from pre-approved procedure in

the Deviations section of the protocol.Changes to acceptance criteria should be documented in the protocol and re-approved prior to re-executing the testing.



Special ConsiderationsTest Method Verification

Suitability of Test Instrumentation

Gage Accuracy and SensitivityOperator Variation

Characterization of Alpha and Beta Errors

Training and Confirmation of Effectiveness

Yes, it applies to visual inspection, dimensional verification,

and automated test methods



Software ValidationEquipment With Embedded Software

Software must be validated

Can be done stand-alone (if possible), or as a part of verifying equipment function (IQ or OQ)

Requires an understanding of the software logic and the functions to be utilized

Should include nominal/margin testing and error handling



Special ConsiderationsIQ / OQ / PQ

Question: Does it really matter what goes where?

Answer: Sometimes, if one validation activity depends on others. (i.e. – training)

Question: I often hear the terms PQ, PPQ, Product Performance Qualification, Process Performance Qualification. What’s the difference??

Answer: These are often defined differently across organizations. However, typically PQ is the overarching term that refers to both process and product performance qualifications.



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Common MistakesPoor Organization

Lack of program structure

Lack of templates and rules for ensuring program consistency

Poor PlanningNo documentation to tie stand-alone validations together (i.e. – Master Validation Plan)

No method to ensure re-validations occur when required (i.e. – sterilization)

Poor DocumentationLittle background information

Story not told

No links to CO/ECO process to ensure changes do not invalidate prior validation activities

Documents

Product and Process Validation Training