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No. of batch for Cleaning Validation
Dear Expert, We are going to start cleaning validation. I need one suggestion from an expert regarding No. batch selection for validation in shared facility.
I will consider three batches for the worst product only. Other than the worst product, should I consider one batch for remaining products?
There is no specific number of runs for cleaning validation. It should be based on risk assessment. But the basic approach is the same principles one uses for process validation. Where 03 runs are conducted usually.
For example once YOU have started the first validation run, the next two process runs should be included as the additional two runs needed to make a total of three consecutive validation runs.
Other than the worst product, you also go with risk assessment to identify the number of run(s) for cleaning validation.