Legal Manufacturing Address Change – multiple registrations at same address

Quality Rep

Registered
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
Moderator
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...?
 

Quality Rep

Registered
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.
 

d_addams

Involved In Discussions
How this can be done is to set up the receiving mfg site as a supplier to the 'original' QMS entity. All operations in the plant are still conducted to the receiving QMS as the supplier. Mixing QMS within the plant would be an absolute bear for the personnel unless you were able to completely separate (ideally physically) all operations. From an operational efficiency standpoint, you definitely wouldn't want duplicate receiving desks, calibration teams, etc. Thus operationally keep it all one 'team' under 1 QMS entity that is a supplier to the 'Design Owner'. Its much easier to have separate design, marketing, management, regulatory teams so that 'original' QMS entity will just no longer have their own Operations personnel.
 
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