Remaining RLDs from pilot study [Regulatives / Guidelines]

posted by wienui  – Germany/Oman, 2023-09-28 20:12 (293 d 08:42 ago) – Posting: # 23727
Views: 1,533

❝ What if sponsor sent 1 bottle containing 56 tabs. of RLD to CRO for pilot study from which only 12 tabs. were utilized. Can rest of the tablets be used for pivotal study from the same opened bottle of RLD? Of course storage conditions were maintained in pharmacy of CRO.

Dear QA,

Sure in this case you can use the rest of the tablets (same batch Nr.) as long as the expiration date is still valid.


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