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”

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

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 …

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 ...

EMA发布的<Compilation of Union Procedures on Inspections and Exchange of Information>是欧盟GMP检查的质量管理手册汇编，在其中的< Conduct of Inspections of Pharmaceutical Manufacturers or Importers>明确描述检查员应当 [1]： 确定质量保证体系中的各个要素对于实现GMP合规有效且适当。 反过来说，以上方面也是企业通过欧盟GMP检查所需优先考虑的要素。 接下来，我们将通过介绍欧盟GMP检查流程来分享企业应注意的事项。 02 欧盟GMP检查的流 …

Eudralex Volume 3 Qualified Person's declaration concerning GMP compliance of the active substance manufacture "The QP declaration template" EMA/334808/2014. Template. The QP declaration template provides a format considered suitable for submission.

2015年12月2日 · Marketing authorisations require a QP declaration (issued by the Qualified Person) to confirm that the active substance (active pharmaceutical ingredient - API) has been manufactured in accordance with the EU-GMP Guide, Part II: Basic Requirements for Active Substances used as Starting Materials.