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Back to the forum  2018-07-23 00:32 CEST (UTC+2h)
priyanka12345
Junior

India,
2018-05-09 15:57

Posting: # 18758
Views: 529
 

 Retention samples [Regulatives / Guidelines]

Dear All

As per FDA guidance for industry on Handling and Retention of BA and BE Testing Samples
the following is stated.

Because the Agency has limited experience with the retention and testing of non-solid oral
dosage forms, the Agency is unable to recommend an upper limit for the retention of non-solid
oral dosage forms at this time.


Can any one please let me know how much quantity is required as reserve samples for suspension.

Regards,
PRIYA


Edit: Guidance linked and subject line changed. Please don’t shout[Helmut]
anky1212
Junior

India,
2018-05-31 13:29

@ priyanka12345
Posting: # 18830
Views: 258
 

 Retention samples

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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