产品质量受权人放行前必须由QC负责人批准？

beiwei5du

产品质量受权人放行前必须由QC负责人(检验部分）批准？？是否有要求QA负责人批准？？
9.14   The authorized person responsible for approving a batch for release should always ensure that the following requirements have been met:
(a)  the marketing authorization and the manufacturing authorization requirements for the product have been met for the batch concerned;
(b)  the principles and guidelines of GMP, as laid down in the guidelines published by WHO, have been followed;
(c)  the principal manufacturing and testing processes have been validated;
(d)  all the necessary checks and tests have been performed and account taken of the production conditions and manufacturing records;
(e)  any planned changes or deviations in manufacturing or QC have been notified in accordance with a well-defined reporting system before any product is released. Such changes may need notification to, and approval by, the medicines regulatory authority;
(f )  any additional sampling, inspection, tests and checks have been carried out or initiated, as appropriate, to cover planned changes and deviations;
(g)  all necessary production and QC documentation has been completed and endorsed by supervisors trained in appropriate disciplines;
(h)  appropriate audits, self-inspections and spot-checks are carried out by experienced and trained staff;
(i)   approval has been given by the head of QC;
(j)   all relevant factors have been considered, including any not specifically associated with the output batch directly under review (e.g. subdivision of output batches from a common input, factors associated with continuous production runs).
选自WHO GMP

beiwei5du

9.13   No batch of product is to be released for sale or supply prior to certification by the authorized person(s). In certain countries, by law, the batch release is a task of the authorized person from production together with the authorized person from QC.
选自WHO GMP

flash02

按中国，只要求质量受权人签字就行了，没QC负责人什么事，

卢青

QC还有这功能？

朱红雪

受权人签字之前肯定有人专门审核QC部分并确认合格的；生产部分同理

beiwei5du

朱红雪 发表于 2017-8-27 15:19
受权人签字之前肯定有人专门审核QC部分并确认合格的；生产部分同理

主要是必须由head of QC批准的问题。这个在国内应该没有如此的必须规定。

915_雨

想省事先叫QC、QA、生产管事的签，
因为领导签字基本不看，不安排别人看，难道自己看。

M.dufresne

实行双批准