Danish plan to develop API audit guidelines draws criticism

Plans by the Danish Medicines Agency to develop a national guideline for active pharmaceutical ingredient (API) supplier auditing by drugmakers have come in for criticism.

Dr. Stefan Kettelhoit of blue inspection GmbH - a German company offering audits and inspections for starting materials and APIs for pharmaceutical clients - maintains that European member states should not take unilateral action in this area.

"A patchwork of national audit standards will certainly weaken the competitiveness of the European drug product industry," according to Dr. Kettelhoit. What is needed, he asserts, is one single international standard since APIs are generally supplied to multiple manufacturers across Europe.

"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," he said.

In May, the Danish authorities published a review of its oversight of API suppliers, concluding that while on the whole they are meeting Good Manufacturing Practice (GMP) standards, pharmaceutical manufacturers' audits of those suppliers were often lacking.

The review was put in place in response to concerns about the safety of the API supply chain in light of events such as the contaminated heparin scandal in 2008 and the general globalisation of API supply to the drug industry.

Dr. Kettelhoit said he would like to see one commonly accepted audit standard in Europe, in accordance with the 'Community Format employed by 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."


Related articles:

EDQM continues clampdown on API manufacturers

Denmark report on APIs finds supplier audits 'inadequate'

EDQM suspends certificates for Chinese ingredients