Retention time of test samples

[MrTetris]

Hello,
I am looking for a guideline on the retention time for test samples. I work for a small medical company which design and produce MDs which undergo mechanical, packaging, cleaning, sterilization... and many more VnV.
I found this reference: Retention Samples.
which seems to indicate 5 years for biological testing, but 5 years seems to be a very long time for mechanical or packaging test samples.
Is it perhaps sufficient storing the files sufficient to recreate the samples (although over time, the manufacturing process might change, resulting in the impossibility of rebuilding the parts...)? Looking for any idea. Thank you in advance!

 

[yodon]

I'm not aware of any requirement to keep device samples used in V&V. You might consider if keeping samples would be beneficial.

 

[v9991]

Hello,
I am looking for a guideline on the retention time for test samples. I work for a small medical company which design and produce MDs which undergo mechanical, packaging, cleaning, sterilization... and many more VnV.
I found this reference: Retention Samples.
which seems to indicate 5 years for biological testing, but 5 years seems to be a very long time for mechanical or packaging test samples.
Is it perhaps sufficient storing the files sufficient to recreate the samples (although over time, the manufacturing process might change, resulting in the impossibility of rebuilding the parts...)? Looking for any idea. Thank you in advance!

The cited reference is for drug products which are part of the corresponding bioequivalence studies.in the context of durg products;
* The samples from the initial exhibit.or.submission batches, however are retained till their shelf life expiry and/or the subsequent validation batches crossing the shelf life. ( which 99% of times turns out to be 5 years., as there are few products with more than 36 years shelf life )
* The samples from subsequent validation or commercial batches are retained 6 months after their shelf life

I am not exposured to medical devices nor the product lines you are indicating, all the references are towards the data retention and not retention samples;

Data retention periods for medical research

Below you find an overview of the retention periods required in the Netherlands for data collected in the context of medical research involving human subjects.

english.ccmo.nl

however, extending the above logic, it would be prudent to retain those samples untill the stability or shelf life or the validation or reliability analysis is completed....