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.
