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[RegAffairs]Compliance with specification at the end of shelf life

Dear all,

In the General Notices chapter of the Ph Eur it is stated that "a 
preparation must comply throughout its period of validity". Does it 
mean that a drug substance or drug product should be tested at the 
end of shelf life against all the tests included in the release 
specification, even if not stability-indicating?

Thanks for any information regarding industry practices on this topic.

Best regards,

Yves Bobinnec
---------------------------------------
Government and Regulatory Bodies
http://www.pharmweb.net/regulatory.html


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