The GMDP-inspection focus for 2026

Compliance with dossier requirements GMP inspections.
In 2026, the Danish Medicines Agency will have a special focus on whether GMP companies comply with the requirements laid down in the dossiers of manufactured medicines. The dossier of a medicine constitutes the basis for its marketing authorisation and has been approved by the authorities. The dossier requirements describe the processes and conditions to be fulfilled to ensure pharmaceutical quality, safety and efficacy. At our inspections, we assess if the companies’ procedures comply with the approved requirements of the dossier, which includes verifying that there are systems in place to ensure that manufacturing still follows the processes under which the marketing authorisation was granted.

The requirements are described in the Danish GMP executive order (no 1538 of 18 December 2012), section 10, and in EU GMP EudraLex vol. 4, Chapter 1 – Principle

Focus on computerised systems at GDP inspections.
In the year ahead, the Danish Medicines Agency will have increased focus on computerised systems when inspecting GDP companies. At our inspections, we will therefore, on a spot-check basis, review compliance with the guidelines’ requirements in relation to computerised systems.
When we give notice of a GDP inspection, we will as always ask for a list of computerised systems used for GDP activities/processes. This could be computerised systems such as ERP, document management and temperature monitoring systems. 

The background and requirements are described in section 3.3.1 of the GDP Guidelines.