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February 2011

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Subject:
From:
"Mazzeo (R&D), Tony" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Fri, 25 Feb 2011 15:42:14 -0500
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Folks,
   I have a question on container closure integrity testing (CCIT) in lieu of sterility for stability studies and especially in regard to post approval stability commitments.
In the past we regarded this as an option for our stability programs.  However, we still test sterility on stability since most countries require it.

On our recent filings the feedback we are getting from the FDA is that CCIT for stability is pretty much a requirement.  I'll note that most of our recent injectable products are biologics.

I'd like to get some benchmarking information on this.  Especially, if you have recent (past 12-18 months) experience.

1. Are you getting feedback from the FDA that CCIT is a requirement for stability programs?

2. Does your organization routinely perform CCIT for stability, either in lieu of sterility or in addition to sterility?

If you send your responses to me, I'll compile them and distribute to the server.
Thank you in advance.

Tony Mazzeo
([log in to unmask])

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