If something stabile is right at the spec limit, the chances are 50/50 that tomorrow's measurement will be OOS. If one is looking at a degradant, odds are that it will be OOS at the next time point. Therefore, you need to look upstream and make sure to not start out right at the spec limit.
If you have "release limits" and "expiry limits" you can avoid this issue by making sure that the release limits are more conservative than the expiry limits.
------------------------------------------
Disclaimer: The views expressed are mine alone and do not necessarily reflect the views of my employer.
------------------------------------------
Emil M Friedman, PhD
Principal Scientist, Statistician
Pharmaceutical Analytics
MannKind Corporation
One Casper Street
Danbury, CT 06810
[log in to unmask]
203-790-2507 (land line at office)
216-287-0821 (cell)
203-527-8260 (land line at home)
[log in to unmask]
-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Mark Paciolla
Sent: Monday, August 06, 2012 11:52 AM
To: [log in to unmask]
Subject: [PSDGLIST] Stability Trends and Method Variability
Hello All,
I'd like to solicit the group about their procedures/experiences for lots placed into the annual stability program which were at the lower or upper specification limit at time of release and have gone OOS due to the variability of the method.
Thanks,
Mark
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Full installation, validation and spare parts also available
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Manufacturer of Quality Stability Chambers and
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