standby and retention samples [Regulatives / Guidelines]

posted by Ajit Thorat – India, 2019-10-30 11:31 (538 d 15:04 ago) – Posting: # 20733
Views: 2,126

» Standby samples are the reserve samples.
» I am asking for TR MOH but we follow primarily EMA and/or FDA guidelines.

Dear zeynep

For USFDA: Retention samples (Investigational medicinal product Test & Reference)
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.For solid oral dosage forms (e.g., tablets, capsules), an upper limit of 300 units each for the test article and reference standard can be considered sufficient to meet the five times quantity.


Ajit Thorat

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

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