Temperature and humidity storage requirements?

I

indramani.m

Guest
#1
hello every body, I would like to ask one question whether the Investigational products for testing purpose has to be stored at particular temperature and humidity? If yes, what are the temperature and humidity limits to be maintained for the storage?

Looking forward for the reply.

regards,
Indramani
 
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MIREGMGR

Inactive Registered Visitor
#3
Indramani.m, I'm not aware of any FDA guidelines or rules that govern test-material environmental conditions other than a general implied requirement that those conditions be such that the investigation being conducted is effective.

Can you give us additional information as to what kind of "investigational products for testing purposes" we're discussing? It's hard to address your questions with any specificity without more knowledge.
 
I

indramani.m

Guest
#4
Hello,

Thanks for your response.
Ours is a Contract Research Organisation (CRO) located at VIzag and the Investigational products means the solid/liquid dosage forms which were available in the market for curing different ailments. It includes antihypertensives, antiulcers, antipsychotics etc. These were tested for its Bioavailability and Bioequivalence in a healthy human body. So before and after dosing to them, their storage conditions have to be maintained and documented.
My question is whether there are any specific storage requirements (esp. humidity) for them?

M.Indramani
 
I

indramani.m

Guest
#6
Hello,

Manufacturer specifications for a Product is with temperature only. But i want to know what the guidelines says regarding humidity.

Please will anybody help me in this regard,

Thanks and regards,
m.Indramani
 

Ajit Basrur

Administrator
Staff member
Administrator
#7
Hello,

Manufacturer specifications for a Product is with temperature only. But i want to know what the guidelines says regarding humidity.

Please will anybody help me in this regard,

Thanks and regards,
m.Indramani
You have to strictly abide with the label claims. If the manufacturer has referred only to temperature, why do you want to study the humidity for it ?

There are many pharmaceutical dosages where the temperature is the sole affecting parameter and not humidity.
 
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