I have a follow on action from a process validation to define yield limits based on 10 batches manufactured. Are there specific guidlines on how to do this - there are not procedures in this company that guide me. Any help would be appreciated - thanks
According to PV guidnce, the company had to risk assessment and to establish the design-contol space for the batches manufacturing.
So, the 10 batch results were to be subject to evaluating on statistical process. If the company had no procesures, it would be out of audition or inspection: in short, not ready to get inspection.
Hi,
There is no specific policy for the fixing of yield limits for the batches, but as per the process validation guidance, if the 10 batches are consistent w.r.t quality and yield then follow the yield as per the development studies procedures or other wise calculate the average yield for 10 batches and apply any statistical tool [± 5 or 3] then it will be fix as the yield range.
But the same procedure should be covered in your internal SOP.