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RegisterRetention handling [Regulatives / Guidelines]
Dear Alhas,
For an FDA submission the answer is clearly: NO. In case of an inspection the trial will be rejected, even if the retention samples are sent back to the CRO.
EMEA: the guideline does not require retention samples to be kept at the site. So no problem to send them back to the sponsor. Document what you do, how much you send back, the batch numbers, etc. I would suggest to keep photocopies or pictures of the containers for both the test product and the reference product.
Other markets: check in the respective guidelines.
Regards
Ohlbe
For an FDA submission the answer is clearly: NO. In case of an inspection the trial will be rejected, even if the retention samples are sent back to the CRO.
EMEA: the guideline does not require retention samples to be kept at the site. So no problem to send them back to the sponsor. Document what you do, how much you send back, the batch numbers, etc. I would suggest to keep photocopies or pictures of the containers for both the test product and the reference product.
Other markets: check in the respective guidelines.
Regards
Ohlbe
Complete thread:
- Retention handling BEAZ 2008-12-02 08:02
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Retention handling chidambarajoshi 2008-12-02 09:14
- Retention handlingOhlbe 2008-12-02 09:45
- Retention handling BEAZ 2008-12-02 10:02
- Retention handling han16 2009-02-17 11:56
- Retention handling Ohlbe 2009-02-18 19:34
- In the night all cats are grey (German saying) Helmut 2009-02-18 21:25
- In the night all cats are grey (French saying too) Ohlbe 2009-02-18 23:45
- In the night all cats are grey (German saying) Helmut 2009-02-18 21:25
- Retention handling Ohlbe 2009-02-18 19:34
Ing. Helmut Schütz