Bioequivalence and Bioavailability Forum

Dear Swapnil,

The current European guideline does not ask for any sample of the investigational medicinal products to be kept at the trial site. After the end of the trial you can either keep the remaining IMP, or return them to the sponsor, or destroy them, based on the protocol and the agreement with the sponsor.

If you and the sponsor decide not to keep the remaining IMP at the trial site, ensure that you have a proper accountability, documented in detail... I would also recommend to keep photocopies or pictures of the containers (primary and secondary), showing the labelling, batch numbers, country of origin of the reference product, etc. Also keep the patient leaflet of the reference product. Pictures of the tablets (or capsules, etc.) themselves, if you don't keep any sample, would also show that the products received matched the description in the certificate of analysis. Still, I would prefer to keep at least a few tablets of each product, to be able to show in case of an audit or of an inspection.

It seems however that most trial sites will prefer to keep the remaining products, even though it can be quite bulky. One reason can be that they do not always know in which country the trial will be submitted.

The requirement to keep samples at the manufacturing site remains, as per GMP.

Regards
Ohlbe