Retention of used blister / strip pack in BA/ BE studies [Regulatives / Guidelines]
❝ 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.
Complete thread:
- Retention of used blister / strip pack in BA/ BE studies nlpati 2016-10-21 05:36 [Regulatives / Guidelines]
- Retention of used blister / strip pack in BA/ BE studiessuds4u 2016-10-21 10:44