standby and retention samples [Regulatives / Guidelines]

posted by Ajit Thorat – India, 2019-10-30 11:31 (331 d 18:52 ago) – Posting: # 20733
Views: 1,827

» 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.

Thanks

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]

Complete thread:

Activity
 Admin contact
21,076 posts in 4,394 threads, 1,468 registered users;
online 2 (0 registered, 2 guests [including 1 identified bots]).
Forum time: Saturday 07:24 CEST (Europe/Vienna)

For every fact
there is an infinity of hypotheses.    Robert M. Pirsig

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5