Hi All,
Trying to develop a sample retention policy for IMP used in clinical trials both US and EU. My original take was to retain 2x of the amount needed for testing and to retain it for 1 year after expiration which would fit with Euralex 4 annex 19 section 3.
However because it is IMP, I would like to get some clarity, if possible, regarding the following from Article 10(4) of Commission Delegated Regulation (EU) No 2017/1569.
Article 11
Retention of samples used for quality control
1. The manufacturer shall retain sufficient samples of each batch of bulk formulated product, of key packaging components used for each finished investigational medicinal product batch and of each batch of finished investigational medicinal product
for at least two years after the completion or discontinuation of the last clinical trial in which the batch was used.This requirement seems odd to me because it does not take into account the expiration date of the IMP.
If the IMP product lot for the retained sample expired years before the trial ended, then what would be the point of retaining it to the end of the trial.
Thanks,
Gene
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Eugene Helsel
Principal Consultant, Halloran Consulting Group
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