In 2011, 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

In June 2014, the final version of the template together with a template guidance was published. In September 2014 the comments that EMA received during the consultation period have been published.

The answers to these comments also give some useful and interesting background information on EMA’s expectations when it comes to API supplier auditing and qualification.

More information can be found here