Template for the qualified person's (QP) declaration concerning
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 …
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 …
【综述】欧盟质量受权人（EU QP）制度及欧盟QP审计 - 知乎
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 …
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 …
EU GMP Annex 16: Certification by a Qualified Person and Batch …
guidance on the certification by a Qualified Person (QP) and on batch release within the European Union (EU) of medicinal products
浅谈质量受权人（QP）制度与欧盟QP审计 - 搜狐
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 …
欧洲质量授权人Qualified Person——到底是怎么回事？ - 知乎
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 …
一文了解欧盟的GMP检查 - 知乎 - 知乎专栏
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 …
Eudralex Volume 3 Qualified Person's declaration concerning …
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 …
The QP Declaration: some Questions remain open
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 …