Danish Medicines Agency decision to develop national guideline for API audits criticized

The Danish Medicines Agency (DMA) intends to develop an own guideline for active pharmaceutical ingredient (API) audit reports, which it says will provide guidance to finished medicinal product manufacturers for the documentation of the Good Manufacturing Practice (GMP) compliance of their API suppliers. This is the result of a survey conducted by the DMW last year concerning the GMP surveillance of pharmaceutical companies.

"Overall the pharmaceutical manufacturers comply with the relevant GMP obligations concerning the quality of APIs but there seems to be also an obvious lack of minimum standards," comments Stefan Kettelhoit, of the blue inspection body GmbH on the result of the survey. "However, the decision of the Danish Agency to develop a national audit-guideline is not very helpful,' according to Dr Kettelhoit.

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