FDA公司注册指什么？通过GMP的场地指什么？

kexiwei

一个药企，准备将部分产品进行美国FDA注册。请问除过编写DMF文件之外，还需要做些什么工作？

1.      Self-Identification of Generic Drug Facilities,Sites and Oragnizations,请问这个是不是就是所谓的公司注册，首次注册后，然后每年的10.01~12.31进行更新就行了，然后每年还要缴费？如果不是，请问通常说的那种公司注册，FACILITY FEE指什么？

2.      Drug Registration and Listing System (DRLS& eDRLS),FDA官网介绍此项目是为了监管药品的安全性，生产企业需要列出其所生产的全部产品。（下面的话是摘自FDA官网）

The Office of Compliance, Immediate Office overseesthe electronic Drug Registration and Listing System (eDRLS), a key component ofthe Food and Drug Administration’s (FDA) ability to monitor drug safety.

Section510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firmsthat manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic andforeign firms must at the time of registration, list all drugs manufactured, prepared,propagated, compounded, or processed for commercial distribution in the U.S. Additionally, foreign establishments must identify a U.S. agent and importers at thetime of their registration.

3.     FDA的已批准的产品的变更指南中，有句话是：If the new site does nothave a Satisfactory CGMP inspection for the type of operation being moved.请问厂地的GMP检查是依赖于产品的GMP检查吧？比如说某个产品通过了FDA官方审计，审计当时该产品所用到的厂地也意味着符合GMP了，不知道我理解的对不对？或者是人家专门有针对厂地的GMP检查，请大师们恕我无知。

问题较多，请大师多多指导。小弟不甚感激。