nlpati
☆    

India,
2016-10-21 07:36
(3539 d 03:12 ago)

Posting: # 16747
Views: 5,375
 

 Retention of used blister / strip pack in BA/ BE studies [Regulatives / Guidelines]

Post reply
Dear Sir/ Madam,

Is it necessary to retain used blister pack / strip pack after dosing? Is there any guide line which mentions about the same?
 
suds4u
☆    

India,
2016-10-21 12:44
(3538 d 22:04 ago)

@ nlpati
Posting: # 16748
Views: 4,031
 

 Retention of used blister / strip pack in BA/ BE studies

Post reply

❝ Is it necessary to retain used blister pack / strip pack after dosing? Is there any guide line which mentions about the same?


Hi, There is no guidance document that spell out the storage of blister pack / strip pack after dosing.

But some CROs have the practice of storing them once the dosing is completed, so that the auditor / inspector can ascertain the authenticity of the trial drug. Its only value addition to show good documentation practices.
 
UA Flag
Activity
 Admin contact
23,656 posts in 4,994 threads, 1,570 registered users;
284 visitors (0 registered, 284 guests [including 22 identified bots]).
Forum time: 10:48 CEST (Europe/Vienna)

It requires a very unusual mind
to undertake the analysis of the obvious.    Alfred North Whitehead

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5