Process Validation By

S.PURUSHOTHAMAN
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Process Validation

Protocol

Planning

Reporting
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Validation Principle

Documented evidence: Process is capable of reliably and repeatedly rendering a product of the required quality Planning, organizing and performing process validation Process validation protocols Data collected and reviewed against predetermined acceptance criteria recorded in validation report
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Approaches to Validation

Prospective Validation Prospective validation performed on an API process should be completed before the commercial distribution of the final drug product manufactured from that API. Concurrent Validation Concurrent validation can be conducted when data from replicate production runs are unavailable because only a limited number of API batches have been produced, API batches are produced infrequently, or API batches are produced by a validated process that has been modified. Retrospective Validation Validation for well established processes that have been used without significant changes to API quality due to changes in raw materials, equipment, systems, facilities, or 4 the production process

Validation Protocol
Brief description of the process Equipment and/or facilities to be used including

measuring or recording equipment (and its calibration status) Process control variables to be monitored Details of the samples to be taken and plan Critical process parameters & product quality attributes to be monitored, together with the test methods Acceptable limits and time schedules Personnel responsibilities Details of methods for recording and evaluating results, including statistical analysis
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Validation Planning
Equipment, and analytical testing methods already fully validated Appropriately trained personnel and batch manufacturing documentation prepared abd made effective Appropriate testing methods and testing protocols are prepared and made effective A number of batches of the final product should then be produced, normally 3 consecutive batches Extensive testing at various stages in the manufacturing process including on the final product and its package

Validation Report
Process description including details of critical steps Detailed summary of the results obtained from in-

process and final testing, including data from failed tests Raw data or reference to these results Any work done in addition to that specified in the protocol Any deviations from the protocol with an explanation Review and comparison of the results with those expected Recommendations and conclusion Changes done in the process during validation requiring change control
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THANK YOU