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