manusyriac
☆    

India,
2018-09-20 09:45
(765 d 03:53 ago)

Posting: # 19293
Views: 1,640
 

 Usage of different lots of RLDs in multistage adaptive studies [Regulatives / Guidelines]

Hi All,

Can we use different lots of RLDS in multistage studies as the study design requires more than 2 years of shelf-life for RLDs. If it is possible please help me to find any relevant regulatory guidance for the same.

Thank you.
ElMaestro
★★★

Belgium?,
2018-09-20 12:19
(765 d 01:19 ago)

@ manusyriac
Posting: # 19294
Views: 1,407
 

 Usage of different lots of RLDs in multistage adaptive studies

Hi manusyriac,

» Can we use different lots of RLDS in multistage studies as the study design requires more than 2 years of shelf-life for RLDs. If it is possible please help me to find any relevant regulatory guidance for the same.

Without being absolutely sure I think this would be ok with most EU authorities for the reasons you state. Less convinced about how HC or FDA or PMDA would see it.
Note that in your case batch and stage will have the same meaning for the product(s) in question.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.
manusyriac
☆    

India,
2018-09-20 13:05
(765 d 00:33 ago)

(edited by Ohlbe on 2018-09-20 23:16)
@ ElMaestro
Posting: # 19295
Views: 1,408
 

 Usage of different lots of RLDs in multistage adaptive studies

Thanks for your quick response.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
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