I have one question suppose water systems under re-qualification & i have start the commercial batch again temporary change control it’s possible? Can i take commercial btach and release after completion phase -II qualification and water systems qualifications results found within limit?
During the water system phase -II qualification, water can be used for the manufacturing operations and produced batches can be released before completion of water validation.
Before using the water, ensure that the Phase-I has been successfully completed without deviations like operating and working of the water system, output quantity as required and output water quality as per pre-determined acceptance criteria.
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