shelf life of record - FDA.COMs Community Forums

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Post: shelf life of record (Topic#2243)

divyangmehta
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Posts: 2

07-23-05 09:19 PM - Post#2243

How much shelf life of the Quality Record ?

Anonymous

08-10-05 03:51 AM - Post#2349

In response to divyangmehta

From a cGMP point of view: Three (3) years from the expiration date of the drug product

From a data integrity point of view: indefinite (archived)

Anonymous

11-07-05 11:15 PM - Post#3092

In response to Anonymous

From a cGMP point of view: Three (3) years from the expiration date of the drug product( However that product came with the stability data to determine the period of shelf life). If product of stability data are stable more than 3 years, continue the stability data and extend it properly.

From a data integrity point of view: indefinite (archived)