[RegAffairs]Re: QC reporting to production

["Yongliang Tou" <yongliang.tou@gmail.com>]

Dear Michael,

I find in ICH Q7A that " 2.13  There should be a quality unit(s) that 
is independent of production and that fulfills both quality assurance 
(QA) and quality control (QC) responsibilities". And i n title 21CFR 
211 " Sec. 211.22 Responsibilities of quality control unit.", it 
specifically states responsibilities of QCU and I think the QCU 
independently runs.

Best,
luke