FDA关于“同一生产地址”和“不同生产地址”的定义

beiwei5du

MANUFACTURING SITES

All owners or operators of all drug establishments (not exempt by regulation) that engage in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs are required to register with the FDA (21 CFR 207.20).  An  establishment  means a place of business under one management at one general physical location (§ 207.3(a)(7)).  A  general physical location is reasonably construed to
include separate buildings within the same city  if  the activities in the buildings are closely related to the same business enterprise, are under the supervision of the same local management, and are all inspected at the same time (ORA Field Management Directive No. 132).
For the purposes of determining the reporting category for moves between buildings, the terms same manufacturing site  and  different manufacturing site mean:  

Domestic Establishments

Same manufacturing site:
•   The new and old buildings are included under the same drug establishment registration number
  and  
•   The same FDA district office is responsible for inspecting the operations in both the new and old buildings.  

Different manufacturing site:  
•   The new and old buildings have different drug establishment registration numbers  
   or
•   Different FDA district offices are responsible for inspecting operations in the new and old buildings.

For domestic establishments, the terms same manufacturing site and  different manufacturing site supersede the terms  contiguous campus ,  same campus, and different campus  as used in the SUPAC guidances.

Foreign Establishments  

Foreign establishments are not currently required to register with the FDA.  On May 14, 1999, FDA published a proposed rule to require registration of foreign establishments (64 FR 26330).  Until registration of foreign establishments is required, same and different manufacturing sites mean:

Same manufacturing site:
•  A contiguous or unbroken site or a set of buildings in adjacent city blocks.  

Different manufacturing site:  
•   The new and old buildings are not on a contiguous site or not in adjacent city blocks.  

beiwei5du

btw:这个现在还适用吗？？？

小金库

学习，谢谢楼主分享！

matnixone

谢谢博主，找到信息出处了