SOCMA and the EFCG want the US FDA to make inspection of overseas API manufacturing sites mandatory, with the facilities paying for the costs themselves.
The Society of Chemical Manufacturers and Affiliates (SOCMA) and the European Fine Chemicals Group (EFCG) made the call in a letter to the agency, arguing that the regulator is not able to keep up with the demands of the globalised drug sector.
“The [FDA’s} Foreign Inspection service was designed and structured decades ago and the 21st century requires something entirely different.”
They cited both the sheer number of inspections and the fact that some take place in regions that are outside of current inspectors’ ‘comfort zones’ as the basis of this contention.
Instead the organisations want the regulator to set up a ‘permanent cadre of inspectors’ for active pharmaceutical ingredient (API) plants outside the US, with the operators of the facility in question paying an annual registration fee.
This registration fee, they suggested, should be between $1,000 and $10,000. They also want the manufacturers to provide details of all APIs produced at the time as well as those due to be made in the following 12-months in the registration information to create an accurate database of manufacturing operations..
SOCMA and EFCG also want participating sites to foot the bill for each inspection with the fee varying according to facility size, number of APIs, travel costs and the number of inspectors and translators required.
Under the proposal, manufacturing facilities successfully passing inspection would be issued with a good manufacturing practice (GMP) certificate detailing all the APIs the for which the site has been inspected.
Both organizations indicated a willingness to pay fees for these inspections when performed on their member-owned facilities outside the US.