Pharmaceutical Discussion Groups

activities, regulations, and practices related to pharmaceutical processes

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Testing this new forum   by  on 2009-05-22 08:49:55
 Subject :Trending towards limit.. 2011-11-22 14:24:15 
Freda
Member
Joined: 2011-05-19 12:39:21
Posts: 1
Location: 
Forum : Stability Group (PSDG)
Topic : Trending towards limit

What steps do you take to monitor material that is trending towards the specification limit but is on an annual testing schedule?

Regards,

Freda Jackson

Stability Chemist

BICI, Petersbur, VA
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 Subject :Low Humidity Excursions.. 2011-09-29 09:22:15 
Denisonn1
Member
Joined: 2011-09-29 08:26:51
Posts: 1
Location: 
Forum : Stability Group (PSDG)
Topic : Low Humidity Excursions

Dear All,

Does anyone have any experience with low humidity excursions during a stability study? There seems to be a lot of information regarding how to proceed if there is a temperature excursion but I can’t seem to find anything regarding humidity excursions.  Has anyone justified low humidity excursions for their products while on stability?  If so, how did you justify it?  And, what data did you use to support this justification?  No temperature excursion, just lower humidity.

 Thanks,

 Stability Manager
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 Subject :Testing this new forum.. 2009-05-22 08:49:55 
admin
Member
Joined: 2009-04-28 08:43:56
Posts: 1
Location: 
Forum : Stability Group (PSDG)
Topic : Testing this new forum

Just testing the capabilities of this forum for use with the PSDG group.
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