生产场地转移的疑问？？

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各位蒲友：
下文节选自FDA GFI  Changes to an Approved NDA or ANDA （2004），那么是否说明了在同一生产地址进行的生产转移活动（除了VI.B.4, VI.C.1.b, and VI.D.5），均不需要向相关的监管方进行报告（诸如备案或批准）。企业内部进行相关的操作即是？？？比如片剂生产线从一号楼1#生产线转移至二号楼2#生产线并不需要官方备案或者审批（如果其他不变的情况下）？？？

VI.  MANUFACTURING SITES

Except for the situations described in sections VI.B.4, VI.C.1.b, and VI.D.5, construction activities at a manufacturing site  or moving production operations within a building or between buildings at the same manufacturing site do not have to be reported to CDER.  
（除了一下VI.B.4, VI.C.1.b, and VI.D.5提及的情况，生产地址上进行的建造活动以及在同一生产地址上的同一厂房或者不同厂房之间进行的生产转移不需要向CDER进行报告）

VI.B.4
B.    Major Changes (Prior Approval Supplement)
The following are examples of changes considered to have a substantial potential to have an adverse effect o n the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product.

4.   Transfer of the manufacture of an aseptically processed sterile drug substance or aseptically processed sterile drug product to (1) a newly constructed or refurbished aseptic processing facility or area or (2) an existing aseptic processing facility or area that does not manufacture similar (including container types and sizes) approved drug products.  An example would be transferring the manufacture of a lyophilized drug product to an existing aseptic process area where no approved lyophilized drug products are manufactured or where the approved lyophilized drug products being manufactured have different container types and/or sizes than the container of the drug product being transferred.  See section VI.C.1.b for recommendations for other manufacturing site changes relating to aseptically processed sterile drug substance or aseptically processed sterile drug product.
（将无菌操作原料药或制剂生产转移至（1）新建或新翻修的无菌操作设施或者区域，（2）已有的但是不生产相同制剂（包括container的类型和大小）的无菌操作设施或区域）

VI.C.1.b
C.    Moderate Changes (Supplement -  Changes Being Effected)  
The following are examples of changes considered to have a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product.  If the new site does not have a satisfactory CGMP inspection for the type of operation being moved (see sect ions VI.B.1 and 2), then FDA recommends that the changes listed below (excluding changes relating to drug substance intermediate manufacturing sites) be submitted in a prior approval supplement.  

1.   Supplement  -  Changes Being Effected in 30 Days  
b.   For aseptically processed sterile drug substance or aseptically processed sterile drug product, a move to an aseptic processing facility or area at the same or different manufacturing site except as provided for in section VI.B.4. （针对于无菌操作的无菌原料药或制剂，除了 VI.B.4提到的情况，转移至同一或者不同生产地址的其他无菌操作设施或者区域）
   
VI.D.5
D.    Minor Changes (Annual Report)
The following are examples of changes considered to hav e a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product.  If the new site does not have a satisfactory CGMP insp ection for the type of operation being moved, then FDA recommends that the changes listed below (excluding changes relating to drug substance intermediate manufacturing sites) be submitted in a prior approval supplement (see sections VI.B.1 and 2) .

5.   A transfer of the manufacture of a finished product sterilized by terminal processes to a newly constructed building or existing building at the same
manufacturing site. (最终灭菌无菌制剂生产转移至在同一生产地址上的新建厂房或已有厂房）

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