Major Phases in Validation

The activities relating to validation studies may be classified into three phases.

Phase 1:

©  This is the Pre-validation Qualification Phase.

©  It covers allactivities relating to 

-        product research anddevelopment, 

-        formulation pilot batch studies,

-        scale-up studies and transfer of technology tocommercial scale batches, 

-        establishingstability conditions and storage, and 

-        handlingof in-process and finished dosage forms,equipment qualification, installationqualification, master production document, operational qualification and processcapacity.

Phase 2: 

©  This is the Process ValidationPhase. 

©  It is designed to verify that 

-        allestablished limits of the critical processparameter are valid 

-        satisfactoryproducts can be produced even under theworst conditions.

Phase 3:

©  Known as the ValidationMaintenance Phase.

©  It requires frequentreview of all process related documents,including 

-        validation of audit reports, toassure that there have been no changes,deviations, failures and modifications to theproduction process 

-        all standardoperating procedures (SOPs), includingchange control procedures, have beenfollowed. 

©  At this stage, the validation teamcomprising of individuals representing allmajor departments also assures that therehave been no changes/deviations thatshould have resulted in requalification andrevalidation.

To learn about the definition of validation and essentials of Pharmaceutical Validation, click here.