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Site Master File for multiple business units within same premises/facility
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Site Master File for multiple business units within same premises/facility
Site Master File for multiple business units within same premises/facility
Site Master File for multiple business units within same premises/facility
Site Master File for multiple business units within same premises/facility
Site Master File for multiple business units within same premises/facility
Site Master File for multiple business units within same premises/facility
Site Master File for multiple business units within same premises/facility
Site Master File for multiple business units within same premises/facility
Site Master File for multiple business units within same premises/facility
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Site Master File for multiple business units within same premises/facility


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Some Related Topic Tags
glp (good laboratory practices), gmp (good manufacturing practices), master copy of a document, multiple business units
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  Post Number #1  
Old 5th July 2016, 12:03 PM
v9991

 
 
Total Posts: 952
Question Site Master File for multiple business units within same premises/facility

we are dealing with following scenario;

main site (GLP) with established site master file.
* a different business unit, working with different qms within the same facility; having same license,
* a different business unit, working with different qms and licenses!
* a newly setup lab setup with higher qms-(GMP) standards (separate QMS); having different license,
(business units of same organization)

my query is :- all above scenario must be handled with same SMF? or in what circumstances, should we initiate different SMF?

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  Post Number #2  
Old 11th July 2016, 03:31 AM
Marc's Avatar
Marc

 
 
Total Posts: 26,502
Re: Site Master File for multiple business units within same premises/facility

I personally can't help, but here is a quick "Bump" - My Thanks in advance to anyone who can help with this one.
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