The EDQM has suggested Google Earth as a potential source of GPS co-ordinate data for manufacturing sites that must be supplied in CEP applications under recently introduced requirements.
The recommendation is part of guidance issued to help certificate of suitability (CEP) comply with the new GPS rules that were introduced in April to help better identify the manufacturing plants where active pharmaceutical ingredients (APIs) are made.
The European Directorate for the Quality of Medicines & Healthcare (EDQM) said firms seeking new or revised CEPs should either use the US internet giant’s ‘virtual earth’ platform or a properly calibrated GPS device to determine facility location.
“Co-ordinates should preferably identify the main entrance of the manufacturing site involved in the production of the substance to be covered by the CEP,” it continued adding that this data must be supplied for every facility involved the production chain.
The drug quality watchdog also revised its application forms to let those seeking new CEPs provide GPS and data universal numbering system (DUNS) information, if available, in their submissions.
“The purpose is to provide more reliability of the site location, in particular in the context the EDQM inspection programme,” it added explaining that in the past facility location information provided on CEP applications was often incomplete.
European API quality focus
The recommendation follows just months after the EDQM revised its guidance on CEP withdrawals to clarify its rules on the appeals process.
The developments are also in keeping with a current Europe-wide focus of the quality of ingredients used in drugs, much of which revolved around concerns that APIs made outside the continent are not made according to appropriate standards.
Speaking in January the EMA said sourcing APIs internationally may let substandard material to enter the supply chain, citing the fact that 12 of the 14 GMP non-compliance reports filed in EudraGMP in 2010 related to producers outside the EU.
Like the EDQM, the agency’s solution also focused on facility inspections and specifically the need for greater international collaboration between regional and national regulatory bodies.
Part of this joint-inspection process involved establishing a more detailed database covering the precise location of manufacturing facilities.