Process Validation Samples

Hi All,

Once we have completed our process validation, we store our ‘rentention/ duplicate’ samples for a period of time. My opinion is that this is not required as once the process is validated no further sampling will be required. From a finished product stand point, samples are held until:) the end ofthere shelf life.

Does anyone have any thoughts on retaining process validation samples?

Thank you.

Dear Austin
I think its the case of post marketing stability surviellance study, its not just about process validation. Usually after validation of first 3 lots, samples are kept on stability upto the end of their shel life.

Usaullly PV is conducted on first three batches, so samples are taken for ongoing stabilty and also pick the samples for retaintion n investagation/ marke complain purpose.