EMA publishes final QP Declaration Template

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

More than three years ago, the EMA has published two draft documents for a template for the QP's declaration concerning GMP compliance of the API used as starting material and verification of its supply chain called "The QP declaration template":

1. The draft template for the Qualified Person's declaration

and

2. the respective draft Q&A on the template for the Qualified Person's declaration

The consultation for the first one ended on 30 April 2011. Now, the final version has been published together with a template guidance.

The QP Declaration should be provided in support of an application for a new marketing authorisation, variation or renewal of a medicinal product(s) authorised in the Community, using EU or national procedures within the scope of the respective Directives.

The QP declaration template itself provides, in a format considered suitable for submission, a basis for demonstrating compliance of the active substance manufacture with GMP requirements and that the manufacturer has relevant knowledge of the supply chain. It has four pages and is not as comprehensive as the initial five page draft. Further, it seems that some comments provided by the various interest groups - like the European QP Association - have been taken into consideration, and a few suggestions for improvement have been implemented. When it comes to audit information, less details are requested now.