Bioequivalence and Bioavailability Forum

Dear Mr Pradeep Labana,

Old EMA guidance states that "The study sponsor will have to retain a sufficient number of all investigational product samples in the study for one year in excess of the accepted shelf life or two years after completion of the trial or until approval whichever is longer to allow re-testing, if it is requested by the authorities". But, how much quantity of samples to be retained is not specified in the new EMA guidelines.

However, as per EMA guidance on GMP, Reference and retention samples of investigational medicinal product, including blinded product should be kept for at least two years after completion or formal discontinuation of the last clinical trial in which the batch was used, whichever period is the longer.

The reference sample should be of sufficient size to permit the carrying out, on, at least, two occasions, of the full analytical controls on the batch in accordance with the IMP dossier submitted for authorisation to conduct the clinical trial.

Reference: Volume 4, EU Guidelines to Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use, Annex 13