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

v9991

Quite Involved in Discussions
#1
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?
 

Marc

Retired Old Goat
Staff member
Admin
#2
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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