Report on compliance with rules on good manufacturing practice by manufacturers of active pharmaceutical ingredients

20 May 2010

Since December 2005, it has been a requirement that any active pharmaceutical ingredients (API) used in medicines with a marketing authorisation in Denmark must be manufactured in compliance with the rules on good manufacturing practice (GMP).

Pharmaceutical companies are obligated to monitor if API manufacturers comply with the GMP rules. Many API manufacturers are, however, located outside of the EU, and cultural differences and large geographical distances therefore complicate the pharmaceutical companies’ obligation to monitor the manufacturers. In 2008, we experienced the possible consequences, as side effects from blood thinning products with the active pharmaceutical ingredient heparin caused several deaths in the USA. The American authorities estimated the likely cause to be contamination of ingredients during the manufacturing processes in China.

Project on manufacture and control of APIs carried out in 2009

In 2009, the Danish Medicines Agency carried out a project to uncover potential risk areas concerning manufacture and control of active pharmaceutical ingredients. The project included laboratory control of medicines on the Danish market as well as inspections of companies both in Denmark and in countries outside the EU.

Read the project findings in the evaluation report

The evaluation report contains our findings. You can find a link to the report in the factbox to the right. We will use the experience gathered from the project to enhance the focus of the guidance and control within the API area.

The factbox to the right also contains further information about the project, questions and answers about API and information about the GMP rules.

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