FDA registers Aptar Pharma plants in France
As contract testing laboratories for extractables
The US Food and Drug Administration has registered Aptar Pharma’s French manufacturing sites in Le Vaudreuil and Val-de-Reuil as contract test laboratories for extractables testing.
With this FDA registration Aptar Pharma, headquartered in the US, says its French sites, which are already ISO-15378 certified and operate with a cGMP-compliant quality system, will further improve customer service and support.
The measurement of extractables from materials in contact with drug product is growing in importance due to increased regulatory scrutiny from organisations such as the FDA. Extractables assessment of plastic and elastomeric components typically used in drug delivery devices forms an integral part of the submission for approval, as well as for the routine controls used to release batches of the drug product.
