QP的IMP声明：一些问答

20160614 ECA新闻：QP的IMP声明：一些问答

GMP News
14/06/2016

QP Declaration for IMPs: some Questions and Answers

QP的IMP声明：一些问答

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate has published a set of Question and Answers on the manufacture of Investigational Medicinal Products (IMPs) in a blog. Quite a few questions are dealing with the import of IMPs and the associated QP Declarations which accompany clinical trial (CT) applications.

英国药监（MHRA）检查组刚刚在一个博客中公布了一系列关于研究用药物（IMP）的问答。有几个问题是关于IMP进口和相关QP声明，其中还有临床试验（CT）申报。

Here is an overview: 这里我们大概看一下：

Extend:延伸

"All sites involved in manufacturing steps starting with the conversion of the API into the dosage form and including primary and secondary packing and also any contract laboratories involved with release or stability testing" should appear on the QP declarations.

“所有从原料药转换成制剂开始的生产步骤所涉及的工厂，包括内包和外包，以及所有放行测试或稳定性测试所涉及的合同实验室”均应出现在QP声明中。

Regulatory inspection instead of own audit: 法规检查替代自主审计

"The starting point for a QP declaration of EU GMP should be an audit conducted by or on behalf of the importing company. (…). A regulatory inspection cannot be used unconditionally to remove the need for your own audit."

“QP的EU GMP声明应基于一次由其自己或代表进口公司所实施的现场审计。常规检查不能无条件使用，用以豁免你自己的审计。”

Audit by QP or not: 是否由QP进行的审计
"An audit does not need to be done by the QP, however the QP needs to be satisfied that it has been done correctly by an appropriately trained individual as the QP will be taking final responsibility."

“审计并不是必须由QP实施，但是QP需要对经过适当培训的人员正确实施审计感到满意才可以，因为QP将承担最终的责任。”

Recognition of Certification by Swiss QP (Responsible Person, RP) 瑞士QP签发的认可证书（负责人，RP）
"Although there is a Mutual Recognition Agreement (MRA) between the EU and Switzerland, it remains a third country therefore the IMP would need to be imported into the EU by an MIA(IMP) holder. (…) and the IMP would need to be certified by a (EU) QP upon import prior to release for use in the clinical trial."

“尽管在EU和瑞士之间有互认协议（MRA），但瑞士仍然是第三国，因此IMP需要由MIA（IMP）持有人进口至欧盟……并且IMP在进口之后放行至临床试验使用之前需要由欧盟的QP出具声明。”

QP statements for APIs used in IMPs 用于IMP的原料药的QP声明
"There is no requirement for APIs used in IMPs to comply with EU GMP Part II but there remains a responsibility for IMP manufacturers to assure themselves that the API is of an appropriate quality."

“对于用于IMP的原料药，不要求其符合EU GMP第二部分，但IMP生产商自己仍有责任确保原料药具备适当的质量。”

Further details and more frequently asked questions can be found in the MHRA Inspectorate Blog.

更多细节，参见MHRA检查组博客。

来源;http://zhuyujiao1972.blog.163.com/blog/static/986947272016515103033677/