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[RegAffairs]Re: Compliance with specification at the end of shelflife

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


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