Is cleaning validation required in case

Is cleaning validation required if , a final crystallization solvent is changed for a compendia API ?

anyone any guidance?

You need to evaluate the following to assess the re-validation requirement for cleaning process…

  • Is there any change in the solubility of API w.r.t. solvent change in the final process?
  • Is the existing cleaning solvent capable to remove the residue of the previous product up to acceptable MACO limits even after solvent change?
  • Is your cleaning method capable to detect the new solvent traces?
  • Is there any control for residual solvents determination at you final specification for new solvent? If so your residual solvent method capable to detect the solvent up to ICH limits?

You can assess your own process like above thoroughly and according to the out come you can conclude the re-validation requirement…

Thanks Prasad Sir.