This document provides guidance on the data to be included in a qualified person (QP) declaration and a template to harmonize its format. QP declaration is required for marketing authorisations to confirm that the active substance has been manufactured in accordance with good manufacturing practice for medicinal products.

The objective of this guidance and the Qualified Person (QP) declaration template is to emphasise the importance of providing a valid declaration, to harmonise the format for the declaration, to forestall questions during assessment, and to enhance the efficiency of the regulatory process, including the timely processing of relevant regulatory s...

QP职责. 在欧盟GMP指南附录16《QP认证和批放行》中明确说明，QP的职责是确保每个批次的生产和检验符合认证所在成员国的法律规定，符合上市许可(marketing authorization, MA)的要求，符合GMP的要求【3】。 QP资质要求

QUESTIONS & ANSWERS: Template for the Qualified Person’s declaration concerning GMP compliance of the active substance used as starting material and verification of its supply chain “The QP declaration template”

2019年9月25日 · 在我国由CDMO企业带动制药国际化的过程中，来自欧洲制药企业的QP（Qualified Person，质量受权人）审计也将是质量控制的重中之重。 本文为读者介绍质量受权人制度以及欧盟质量受权人的审计，着重分享了武汉喜康面对欧盟QP审计的经验和欧盟QP审计的 …

guidance on the certification by a Qualified Person (QP) and on batch release within the European Union (EU) of medicinal products

欧盟gmp指南的附录16详细说明了qp的工作职责，包括确保： 质量授权人还需要考虑所有可能影响药品质量的其他因素。qp可以将上述任务进行委托，譬如委托给给美国制造商及其 质量控制 部门，但这并不包括批次的认证和发布。由于质量授权人负责确保所有质量 ...

Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial (OJ C82, 30.3.2010, p. 1) confirm that I am a …

This QP declaration is applicable to the following registered MIAH(s), that use the active substance as a starting material and/or is responsible for QP certification of the finished batch of a human or veterinary medicinal product, where the active substance is registered as a starting material and is manufactured at the sites listed in Part A:

ema官方回答： MAH和负责产品QP认证的MIA持有人之间应签订直接书面合同。 负责产品QP认证的MIA持有人与在产品进行认证前的生产、进口、试验、储存的各个阶段所涉及的工厂(以下简称合同制造商)之间也应签订直接书面合同。