Expert: Michael Anisfeld - 5/22/2007

Question
QUESTION: Dear Dr. Anisfeld
Regarding the withdrawn stability study samples at study points, what is the allowable period and at what condition samples should be stored before starting analysis?


ANSWER: 1, 2, and 3 months samples should be withdrawn and tested with 3 days of the target date;

6, 9, and 12 month samples should be withdrawn and tested within 7 days of the target date;

18, 24, 36 month samples should be withdrawn and tested with 14 days of the target date.

after withdrawal keep samples in refrigerator until tested,


---------- FOLLOW-UP ----------

QUESTION: Dear Dr. Anisfeld
Sorry for inconvenience, but I tried to search for this kind of information in the ICH guidelines but I found nothing, is this scenario a company trend or there is an official reference?

Also I have a question regarding the GMP rules, during the packaging process of the pharmaceutical cream, is it accepted from the GMP point of view to unpack the defected (rejected) tubes and refill the contents? If its accepted, does it considered reprocess action?

Thanks and best regards


Answer
The timings I provided came from an old FDA guideline from FDA's Office of General Drugs. Regretfully this is no longer on the FDA website, and I no longer have the original.

Yes, you can open the tubes and repackage them if you can figure out a way to do this without in any way contaminating the recycled cream - an almost impossible job.

Additionally due to the economics, this almost never done.