Initiative by Members of EU Parliament Calls for GMP Inspections of API Manufacturing Sites within and outside the EU

GMP News No. 800

GMP News
26 September 2006

Initiative by Members of EUParliament Calls for
GMP Inspections of API Manufacturing Sites within and outside the EU

On 4 September, 5 Members of the EU Parliament published a writtendeclaration. In their document, the 5 Members of Parliament explain thatthe certification of Good Manufacturing Practice (GMP) ensures an improvedquality of active pharmaceutical ingredients. They mention that thedifferent manufacturers in the EU do not receive a GMP certificate untiltheir sites have been successfully inspected by a GMP inspectorate from anEU member state, whereas manufacturers in third countries are notinspected. The Members of Parliament consider this practice as a risk tothe patients' health.

Therefore, the declaration calls for inspections of all manufacturersof active pharmaceutical ingredients by EU authorities in order to obtaina GMP certificate - no matter if the manufacturing sites are locatedwithin or outside the Community. Besides, the group proposes theintroduction of traceability of the active ingredients. This should bereached by discouraging the relabelling of active ingredients.

Till 4 December 2006, comments are compiled and evaluated. If therequirements proposed in the declaration are implemented, the consequenceswill be far-reaching. The present regulation requiring the manufacturerof the medicinal product to verify the GMP compliance of an active ingredient (usuallyby means of an audit) will be enhanced by supervision on the part of theauthorities.

The GMP-compliant manufacture of active pharmaceutical ingredients is aprerequisite for their use in medicinal products in any case (even if thisinitiative will not be passed in the European Parliament). For thisreason, ECA supports and/or co-sponsors qualification seminars andconferences:

APIC/CEFIC is organising:

APIC/CEFIC is organising (co-sponsored by ECA):

Oliver Schmidt
On behalf of ECA



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