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Re: Reprocessing of drug product

Yes refilteration as per the same filteration technique is Reprocess and if it is with different technique or through different filteration category then it is to be considered as rework.

Regards
B.Anil Kumar Singh
Sr.Executive-QA/Dr.Reddy's

On Fri, Mar 28, 2008 at 1:45 AM, rajaneesh B R < rajaneesh.br@seruminstitute.com> wrote:

Dear Forum members
Sorry for error!
 
Does Refiltration of bulk solution in case of failure of post filtration integrity of filter during routine manufacturing come under reprocessing?
 
Thanks in advance
 
RAJANEESH.BR
Regulatory Affairs
 
 


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