After cleaning g of equipment we are taking swab sample for micro and chemical.is it must required?and if required than how can I reduced it?
I don’t know of any regulation stating you have to swab equipment after every cleaning. The important thing is to demonstrate that your cleaning procedure is in control. Review the data you currently have (I’d say 20-25 data points min per location). Use risk based approach (risk assessment) to justify reduction of sampling frequency if your data supports so.
Thanks you for responding sir,
You are right sir I was suggested my company like you, we have enough data and all data in under control so on that base we can stope the swab sampling am I right?
Have you any guidelines which have Wright that if you have cleaning process validation than its not required for swab sampling
If you had done the cleaning validation and have set the MACO limit.
you should have clear SOP for cleaning of equipment by using specific cleaning agent, as mentioned in your CV.
Still you want to go with critically, then gather the data of Appx. 10-15 batches make a trentd analysis for the evidence and consistency.
Finally perform Risk assessment document.
In addition to that you can still perform test after every 10th Batch, as procedure with Type A and Type B cleaning