How many number of unused and reconsituted samples do we need to retain after phase II or III clinical trial?

Question

This a questions for people in pharmaceutical industries or familar with FDA guidelines:

And how long should we keep them?

Answer 1

Since you're in clinical trials, you fall under GCP guidelines rather than GMP. From what I've been able to find, the quantity of reserve samples should be sufficient to permit the Agency to perform five times all of the release tests required in the application or supplemental application. The guideline bulletin I've linked to below doesn't specify a time period, so one would assume one would retain them indefinitely, as long as the drug under trials was in submission to the FDA. Once approved by the FDA, your research data and all samples fall under GMP guidelines, where the retention requirements are a little different.