An NSF International Company QP’s Declaration of GMP Compliance for Investigational Medical Products
Friday the 3rd May 2013
On 30 April 2025 the European Commission published the final version of a ‘Template for the QP’s Declaration of GMP Compliance for IMPs manufactured in non-EU countries’ as an addition to Eudralex volume 10.
This is a simple two page template. The declaration can be made on the basis of either (i) an audit by the QP, where you have to say who the ‘auditing party’ was and the date of the last audit; or (ii) if the manufacturing site has not been audited, a justification as to how the QP knows that the site meets EU GMP.
