September 2012


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Jessica Wong <[log in to unmask]>
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Pharmaceutical Stability Discussion Group <[log in to unmask]>
Fri, 7 Sep 2012 08:50:40 -0700
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Dear Stabilitarians,

Is there a requirement to place annual representative lot for each primary packaging configuration?  If not, what is your company's practice?  I cannot find any answer under SUPAC nor ICH.

For example:

Primary package A was approved and used for many years.

Primary package B was just approved but already proven to be equivalent to Primary Package A.

Both are approved for packaging at the same packaging site.

(1)     If we continue to use both configurations (A & B), is there a requirement to place both on stability as the annual representative lots?
(2)     If there is no requirement, do you alternate each configuration?  i.e. Annual lot on Packaging A in 2012 and annual lot on Packaging B in 2013.
(3)     Or do you matrix the time points for both configs and place both on annual stability?

Please advice.

Thank you,

Gilead Sciences

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