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.
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 ” … described and supported by technical agreements between these sites (see Part B and E).
4. Format of the QP declaration template The attached QP declaration template provides a suitable means for documenting confirmation that the active substance manufacture complies with GMP requirements. The format of the QP declaration template is in five parts (Parts A to E). PART A: Concerned active substance manufacturing sites, If you wish to carry out studies in the EU in the future, include in your quality agreement a clause allowing you to review your PQ`s audit reports for studies that extend into EU countries and are subject to the publication of the PQ. If possible, use a QP for third-party audits to circumvent questions about the acceptability of the EU audit. 1.
Qualified Person . 4.1 Each party shall appoint a Qualified Person who shall be responsible for performing, or supervising and ensuring the performance of, as appropriate, such party’s duties and tasks under this Agreement . 4.2 Promptly after the signature of this Agreement , each party shall notify the other of the particulars of its Qualified Person (name, postal and e-mail address, telephone …
Template for the Qualified Person’s Declaration Concerning GMP …
Guidance for the template for the qualified person’s …
QP – Qualified Person: Publications, 8+ Quality Agreement Templates – PDF, DOC | Free & Premium …
