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

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

Therefore, the declaration calls for inspections of all manufacturers of active pharmaceutical ingredients by EU authorities in order to obtain a GMP certificate - no matter if the manufacturing sites are located within or outside the Community. Besides, the group proposes the introduction of traceability of the active ingredients. This should be reached by discouraging the relabelling of active ingredients.

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

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

APIC/CEFIC is organising:

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

 
Author:
Oliver Schmidt
On behalf of ECA

Source
 

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