关于part 11对API的适用性

beiwei5du

关于part 11对API的适用性，各位蒲友，下面一段话的意思怎么理解呢？？

syhorchid

谢谢分享

kslam

Compliance Guidance Manual Program (检查员指导手册) 7356.002F

PART I - BACKGROUND

GENERAL


APIs are subject to the adulteration provisions of Section 501(a)(2)(B) of the Act, which requires all drugs to be manufactured in conformance with CGMP. No distinction is made between an API and a finished pharmaceutical in the Act and the failure of either to comply with CGMP constitutes a violation of the Act. FDA has not promulgated CGMP regulations specifically for APIs or drug components (as we have for finished pharmaceuticals). Thus, the use of “CGMP” in this document refers to the requirements of the Act rather than the requirements of 21 CFR Parts 210 and 211 regulations for finished pharmaceuticals.

北重楼

不管怎么说数据完整性已经成为检查问题的最大突破点