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?
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?