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April 2015

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Subject:
From:
Steve Parker <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 22 Apr 2015 14:11:26 +0000
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I am interested in obtaining feedback on the common practices followed by industry for stability chamber excursions. I am looking at the non-sterile industry specifically.

1)      What is the typical response for a temperature and/or humidity excursion <24 hours in duration?

a.       For > 24 hours?

2)      What is the response for temperature excursions that are  5 C of the set point?

a.       For  10 C?

b.      For both conditions above, when <, > 24 hours in duration?

3)      What is the response for humidity excursions that are  5% of the set point?

a.       For  10%?

b.      For both conditions above, when <, > 24 hours in duration?

4)      What are the criteria used to determine that a study is to be extended as a result of an excursion; e.g., the CRT chamber has an humidity excursion for 1 day, the contents are at various time points of their studies, and the studies are for 36 months; is there a general rule of thumb for how much time is added to each study, dependent upon the sample's current time point?

a.       What if the above is an accelerated chamber where the total study time is for 6 months?

5)      When there is an excursion ( either temperature and/or humidity) that is < 24 hours in duration, then 2 days later there is another excursion which is < 24 hours in duration, are these treated as independent occurrences or does one take the cumulative time of the excursion to determine the appropriate response?

a.       What if the excursions are 1 week apart?

b.      If the cumulative time is used in the determination and is 24 hours or greater, what is the response?

c.       If the individual excursions are 24 hours or greater, what would the response be, given the situation(s) above?
Thanks for your responses in advance.


Stephen W. Parker


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