Hi Thomas,
In one of my previous jobs, we would frequently have a gap of up to 6
months between manufacture and start of stability. This has been reviewed
by the FDA without comment. The biggest danger in having this gap is a
potential OOS on stability prior to reaching the expiry timepoint, since
this would be beyond the actual expiry of the product. To cover this
situation, we also tested product during the month of expiration.
I hope this helps.
Mit freundlichen Grüssen
Best regards,
Mark A. Schreiber, Ph.D.
Sr. Manager, Analytical and Microbiology Labs
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BIOTRONIK AG
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8180 Bülach, Switzerland
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Mail: [log in to unmask]
From:
Thomas Vater <[log in to unmask]>
To:
[log in to unmask]
Date:
03/28/2011 09:17 PM
Subject:
[PSDGLIST] Time between Manufacturing date and Study start date
Sent by:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Dear colleagues out there,
since I did not find an answer myself, I would like to pose the following
question:
Is there in any guideline a requirement for a maximum time between
Manufacturing date and Study start date (of the stability study)?
Would be especially interested in the requirements of the FDA.
Hoping for help
Thomas
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Provider of Complete Validation & Calibration Services
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