Bioequivalence and Bioavailability Forum

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