质量授权人不了解生产工艺如何放行？？

beiwei5du

曾了解有生产工艺对质量授权人和QA保密的公司。此种情况下，最终质量受权人如何有效的对产品放行呢？？？
下文选自EU GMP《Annex 16: Certification by a Qualified Person and Batch Release 》

The purpose of controlling batch release is notably to ensure that:
i.  The  batch  has  been  manufactured  and  checked  in  accordance  with  the requirements of its MA.
ii.  The batch has been manufactured and checked in accordance with the principles and guidelines of GMP.
iii.  Any other relevant legal requirements are taken into account.
iv.  In the event that a quality defect as referred to in Chapter 8 of EudraLex, Volume 4,  Part  I, needs  to  be  investigated  or  a  batch  recalled,  to ensure  that  any  QPs involved in the certification or confirmationand any relevant records are readily identifiable.

1.4.  For  manufacturing steps  performed  at  sites  in  the  EU each  manufacturing  site must have at least one QP.
1.4.1 Where the site only undertakes partial manufacturing operations in relation to  a  batch,  then  a  QP  at  that  site  must  at  least  confirm  that  the  operations undertaken by  the  site  have  been  performed  in  accordance  with  GMP  and the  terms  of  the  written  agreement  detailing  the  operations  for  which  the site  is  responsible.  If  the  QP  is  responsible  for  providing  confirmation  of compliance for those operations with the relevant MA, then the QP should have access to the necessary details of the MA（这个是针对于有partial steps外包的情况，相应的负责该部分的QP不一定需要了解MA，关于MA的符合性问题可以由finished medicine QP进行）.
1.4.2 The  QP  who  performs  certification  of  the  finished  product  batch  may assume full responsibility for all stages of manufacture of the batch or this
responsibility  may  be  shared  with  other  QPs  who  have  provided confirmation for specified steps in the manufacture and control of a batch.  These could be other QPs who are operating under the same manufacturing authorisation (MIA) holder or QPs operating under different MIA holders.
1.4.3 Any sharing of responsibilities amongst QPs in relation to compliance of a batch  must  be  defined  in  a  document  formally  agreed  by  all  parties.    This document  should  detail  responsibility  for  assessment  of  the  impact  any deviation(s) has/have on compliance of the batch with GMP and the MA.

成慧潫

又来秀鸟语了。
母语出错了：质量受权人，不是授权人

starnux

Romhex 发表于 2017-8-27 12:24
又来秀鸟语了。
母语出错了：质量受权人，不是授权人

连这都区分不好，还好意思长篇大论。

玻璃杯

这个不需要懂，QP会写 同意 即可

beiwei5du

玻璃杯 发表于 2017-8-27 21:39
这个不需要懂，QP会写 同意 即可

反正QP背锅，哈哈！

guigui1957

会写同意就行，背锅侠嘛。

57600661

质量受权人任职资质上有明确要求