nlpati
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India,
2016-10-21 07:36
(2743 d 03:44 ago)

Posting: # 16747
Views: 4,032
 

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

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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
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India,
2016-10-21 12:44
(2742 d 22:36 ago)

@ nlpati
Posting: # 16748
Views: 3,013
 

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

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❝ 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.
 
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