Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-06-20 07:47 CEST (UTC+2h)

Usage of Light condition during study [Study Per­for­mance]

posted by anky1212 - India, 2017-09-13 08:47  - Posting: # 17804
Views: 928

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

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,395 posts in 3,909 threads, 1,174 registered users;
online 33 (0 registered, 33 guests [including 21 identified bots]).

The analysis of variance is not a mathematical theorem,
but rather a convenient method of arranging the arithmetic.    R.A. Fisher

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed