If we are changing coating solution solvent inplace of previous solvent so in case shall we performed all stage from manufacturing to packing?
For Change in solvent, process should be validated to ensure the output product meets the specifications including content of residual solvents…
Can we start revalidation from coating section?
As per the proposed change there is impact in coating stage, hence coating stage to be re validated with three lots or 3 batches.
Coated tabs should meet FPS requirements.