Cleaning between different lots of same product


Do we require cleaning in between two lots of same product or we can go ahead without cleaning? As product has same formulations there is no variation in components except two different lots.

Is there anything on FDA website about strictly following any guideline about this issue?

If you have validation data to show that you can make 2, 3, 4, etc. lots of the same product and effectively clean your equipment per the SOP, you can do so.

As there is no risk with cross-contamination, you do not need to clean between lots. However, please consider:

  • deterioration of residues
  • contamination by other substances
  • micro-biological contamination
As stated by gsmith, provide validation data that making the cleaning between lots redundant does not impede product quality