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?
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?