Retention samples [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2021-04-13 19:07 (442 d 17:33 ago) – Posting: # 22308
Views: 1,725

(edited by dshah on 2021-04-13 19:19)

Dear Vinodvasala!

Please search in forum for previous discussions  ,  ,  . In general as per Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)- 30 units for Drug Products Manufactured in Single-Dose Units or 3 units for Drug Products Manufactured in Multi-Dose Units for US regulatory and 300 units for 5X testing (safer approach).
Regards,
Dshah

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