anky1212
☆    

India,
2017-07-20 06:08
(1425 d 22:20 ago)

Posting: # 17567
Views: 6,160
 

 Requirement of temperature data before dosing [Study Per­for­mance]

Hi All,

Please note following scenario,

Sponsor going to ship IP today but sponsor is not able to sent temperature data during shipment of product to CRO. Dispensing has been done without having temperature data during shipment. Tommorrow, there is dosing of subject.

Is it any concern for dispensing as well as dosing of subject even though temperature data during shipment not available?

Please provide your view on above scenario (along with guidance if available).
Ohlbe
★★★

France,
2017-07-20 07:57
(1425 d 20:31 ago)

@ anky1212
Posting: # 17568
Views: 5,474
 

 Requirement of temperature data before dosing

Dear Anky,

What are the recommendation for storage of the IMP ?

If the product is to be kept refrigerated or frozen: yes, this is a problem, and I would not dose the subjects without temperature data.

If not: it depends on the recommendations (below 25°C, below 30°C, or nothing ?), on the stability data that the sponsor has on file (40°C / 70 % HR: e.g. if stable for 3 months but not 6, that's still OK; if unstable after 1 month, could be problematic) and on the duration of shipment.

Regards
Ohlbe
anky1212
☆    

India,
2017-07-20 08:21
(1425 d 20:06 ago)

@ Ohlbe
Posting: # 17572
Views: 5,437
 

 Requirement of temperature data before dosing

Dear Ohlbe,

Thanks for reply.

I would like to inform that sponsor is not going to give stabiity data to CRO.

My point is whether we can dose the subject if we do not have temperature data from dispatch of IP from Sponsor's manufacturing site to CRO.

Whether it is an safety issue for subject?
Ohlbe
★★★

France,
2017-07-20 08:24
(1425 d 20:04 ago)

@ anky1212
Posting: # 17573
Views: 5,434
 

 Requirement of temperature data before dosing

Dear Anky,

I can't answer your questions if you don't answer mine. You know what product you are dealing with and what information you have in hand. I don't.

Regards
Ohlbe
anky1212
☆    

India,
2017-07-20 09:33
(1425 d 18:55 ago)

@ Ohlbe
Posting: # 17574
Views: 5,473
 

 Requirement of temperature data before dosing

Storage condition is to store product between 15-30 degree centrigrade
ElMaestro
★★★

Denmark,
2017-07-20 10:13
(1425 d 18:15 ago)

@ anky1212
Posting: # 17575
Views: 5,466
 

 Requirement of temperature data before dosing

Hi anky1212,

» Storage condition is to store product between 15-30 degree centrigrade

If you are not sure the IMP was stored within the storage recommendation interval, or that any deviations do not affect the quality (/safety/efficacy) then you should probably not dose any subjects with it. Storage conditions exist for a reason.

Quarantine the IMP, contact the sponsor to get a statement from the release office or QP. All this is likely a part of your QMS already.:-)

Pass or fail!
ElMaestro
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