Danish plans to develop its own guidelines for API audit reports have been criticised by a body that is calling for harmonisation across Europe.
Taking a country-by-country approach, as opposed to adopting an international standard, could create difficulties for active pharmaceutical ingredient (API) producers that supply firms several countries.
This is the view expressed by Stefan Kettelhoit, of the blue inspection body GmbH. Kettelhoit said a country-by-country approach “will certainly weaken the competitiveness of the European drug product industry”.
“It is not understandable, that on one hand the GMP rules for manufacturing are harmonised in Europe, but on the other hand the surveillance standards of these rules are handled in a different manner from country to country”, said Kettelhoit.
Instead of taking a “patchwork” approach to audit guidelines Kettelhoit believes one commonly accepted audit standard should be adopted in Europe. This would be in line with the “Community Format” of the European Medicines Agency (EMA).
“Acting as API auditor, I think this report format is quite suitable. Our reports, which have been created based upon this format, are already accepted throughout Europe”, said Kettelhoit.
The Danish report
The comments made by Kettelhoit were issued in response to a report published in May by the Danish Medicines Authority (DMA). In the report , which was commissioned in the wake of the heparin contamination, the DMA found deficiencies in the auditing of suppliers.
Specifically, it found the quality of audits and audit reports should be improved for both API manufacturers and traders.
“Based on the observations made in the project, the DMA will prepare guidelines for the finished product manufacturers’ auditors for use in connection with the preparation of audit reports”, concluded the report.