Dear Yves,
Good Morning!!
I agree with Brian comment that For a European marketing
authorisation application the information includes the release
specification and the shelf life specification
But when an preparation must comply throughout its period of
validity, it means that it must meet the shelf life specification
limits (acceptance criteria) as it includes stability indicating
parameters for finished product. Period of validity indicates the
shelf life of product.
Once your drug substance or drug product is kept under stability
condition, then it should be always checked with shelf life
specification.
Also if your product complies with Shelf life specification then it
gives assurance that your product is stable and complying with
current standards.
Hope this clears your query.
Thanks
--
With Regards,
Surender Kr Kamal, M.Pharm
Deputy Manager-International Regulatory Affairs
Modi-Mundipharma Pvt Ltd,
New Delhi
---------------------------------------
Government and Regulatory Bodies
http://www.pharmweb.net/regulatory.html
|