Retention samples [Regulatives / Guidelines]

posted by anky1212 – India, 2018-05-31 13:29 (1286 d 07:23 ago) – Posting: # 18830
Views: 1,416

Dear Priyanka,

As per USFDA guidance, "The quantity of reserve samples should be sufficient to permit the Agency to perform five times all of the release tests required in the application or supplemental application. "

Same need to follow.


Edit: Guidance linked. [Helmut]

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