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July 2012

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Subject:
From:
Kristina Škot <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 25 Jul 2012 02:42:52 -0400
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What are obligations concerning stability in the case of change in manufacturer of API (replacement or addition) when new and previously used API both have CEPs, and finished product release and shelf life specifications (parameters, methods and requirements) remain the same? How many batches requires these variation to put on stability test? 
Is there any guideline which lays down the rule about this variation?

EC No 1234/2008, Annex, refers only to change in the manufacturer of API where CEP is not part of approved dossier, or new manufacturer is supported by ASMF, or uses different route of synthesis or manufacturing conditions.

Thanks.

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