Process Validation By

Process Validation

Protocol

Planning

Reporting
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Validation Principle

Documented evidence:
Process is capable of rendering a product of the required quality Planning, organizing and performing process

reliably and repeatedly

 Prospective Validation

Approaches to Validation

Prospective validation performed on an API process should be completed before the commercial distribution of the final drug product manufactured from that API/Intermediates.

Concurrent Validation

Concurrent validation can be conducted when data from replicate production runs are unavailable because only a limited number of batches have been produced, batches are produced infrequently, or API/Intermediates batches are produced by a validated process that has been modified. Validation for well established processes that have been used without significant changes to API/Intermediates quality due to changes in raw materials, equipment, systems, facilities, or the production process

Retrospective Validation

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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Equipment and analytical

testing methods are available. Appropriately trained personnel and batch manufacturing documentation prepared

Validation Planning

Validation Report

Process description including

details of critical steps Detailed summary of the results obtained from inprocess and final testing, including data from failed tests Raw data or reference to

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