hi sir
we are cleaning our equipments with detergent . during cleaning validation of the worst case we are just finding the unknown peak in the chromatogram. for all the three batches. the unknown peak is only removed by again cleaning the equipments with water but in all the cases the ECL value is below the limit i.e MACO for GLIMIPIRIDE is within the limit.
can any body suggest is there any need to change my cleaning procedure.
This issue has been discussed for a few time.
The recent 483 from FDA is very concern about unknown peaks detected in CV sample. You will have to at least determine if it is carry over from previous batch actives, degradation from the active of interest, Placebo, cleaning agent or swabbing materials.
In your case if it is removable after a water rinse, I will suggest you change the cleaning procedure.
Best reguards,
B0b.
[quote=amanpaul]hi sir
we are cleaning our equipments with detergent . during cleaning validation of the worst case we are just finding the unknown peak in the chromatogram. for all the three batches. the unknown peak is only removed by again cleaning the equipments with water but in all the cases the ECL value is below the limit i.e MACO for GLIMIPIRIDE is within the limit.
can any body suggest is there any need to change my cleaning procedure.[/quote]