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Cleaning validation of batch size changed and brand name changed products on every mo

Dear Sir

we have alrady conducted the cleaning validation of certain OSD products afterthat every month there is

1.New products are adding to our facilty .

2.Batch size changed from the product which is already considered in cleaning validation .

3.Same active and excipient with identical qnty but the brand name is changed according to the market demand.

is there any requiment for conducting cleaning validationon every month for these condition again or only make any assesment report?.

Asir

Dear Anna,

I think this can be handled by an assessment report, especially if you have used a worst case strategy, in which case you redo the calculations to demonstrate that your case remains the worst one (a change in brand name should be no issue, for the worst case is the analyte itself and not the brand). We have put up a (fairly complex) spreadsheet which contains the product information and links each piece of equipment with the products and batch sizes manufactured, and the resulting worst case for each equipment. For some equipment a way to simplify this is to use for each piece of equipment the smallest batch size that can be manufactured in it (result of PQ), and setting this same batch size for the equipment downstream (e.g.: if the smallest batch size for a 1000 l blender is approx. 150 kg, the batch size for the tablet press, which per se has no minimum batch size, would be the same).

Best regards

Alfred