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

posted by suds4u – India, 2016-10-21 12:44 (3032 d 04:27 ago) – Posting: # 16748
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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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