QMS for Life Sciences
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Legal Manufacturing Address Change – multiple registrations at same address

#1
We are outsourcing manufacturing and closing a division’s manufacturing facility and. The current plan is maintain the division’s QMS and registration and change the Legal Manufacturer address to the same address as another division. Certain functions will continue to operate under the old QMS but be co-located at the new address.
We have recently been told that you cannot more than one registration at the same address unless:
1) Manufacturing lines are physically separated,
2) Employees are not commingled among businesses at the site
3) Most functions are separate except some common set of site services that are not central to the activities requiring registration, e.g. HR and building services
4) Each business is under different General Management
5) Each business has separate Management Review (Results may roll up but the primary management review is conducted separately) and
6) Each business has the resources to effectively support an FDA inspection at the site.

Is that a common understanding about having multiple registrations at the same address.

By not being able to do this will have significant negative impact of the plant closure strategy.

Any input, suggestions or solutions?
 

Ronen E

Problem Solver
Staff member
Moderator
#2
1-6 above make a lot of sense to me, though I've never been exposed to these requirements before.
You were told that by...?
 
#3
Ronen, We were advised this by our in-house legal FDA counsel, as well as by our in-house specialist of plant-to-plant transfer. They say eh risk to this is that even if you have a separate registration, if the other registration is under scrutiny, then you, just by being in the same building, are subject to inspection as well.
 
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