Process Validation Samples

Austin_Stewart · October 11, 2007, 1:25am

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.
Austin

Shahid_Ali · October 11, 2007, 10:34pm

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.

Shahnawaz · October 12, 2007, 10:02pm

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.