Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-11-24 06:48 CET (UTC+1h)
 
anky1212
Junior

India,
2017-09-13 08:47

Posting: # 17804
Views: 430
 

 Usage of Light condition during study [Study Per­for­mance]

Hello All,

Referring to storage conditions mentioned over reference product container, i.e "Dispense in tight light resistant container", I am conducting accountability and physical verification using sodium vapor lamp light.

Further, using Amber colored bottles for dispensing of product and doing dosing activity in sodium vapor lamp light as a precaution.

As per my knowledge, for specific condition as mentioned over reference product container like I mentioned above, It means product should not be exposed to direct sun light.

IF Method validation done using sodium vapor lamp light, we are doing all activity using the same light i.e. verification and accountability of IPs, dispensing, dosing, sample collection, separation, segregation etc.

Same practice is followed in most of CROs.

Different Auditors have different views on the same.

Some are asking to do so and some are not.

Please provide your expert view.

Thanks
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
17,494 Posts in 3,746 Threads, 1,087 registered users;
33 users online (0 registered, 33 guests).

The belief that there is only one truth and
that oneself is in possession of it,
seems to me the deepest root of all
that is evil in the world.    Max Born

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed