Aptar Pharma Registers Contract Test Laboratories With US FDA
Aptar Pharma’s French manufacturing sites in Le Vaudreuil and Val-de-Reuil have been registered as Contract Test Laboratories for extractables testing with the US FDA. A number of pharmaceutical and biotechnology companies working with Aptar Pharma drug delivery devices have expressed a requirement to use Aptar Pharma extractables testing for batch release of their drug products. They can now benefit from this advantageous Aptar Pharma service.
Through decades of experience working closely with its pharmaceutical and biotechnology customers in a spirit of continuous improvement, Aptar Pharma understands their evolving needs. As a world-leading supplier of innovative non-invasive drug delivery devices, Aptar Pharma has developed a variety of analytical capabilities, of which extractables data is critical for customers. Now that Aptar Pharma analytical laboratories have been registered with the FDA, customers can reduce their own testing burden, further enhancing the value of their partnership with Aptar Pharma.
Pharmaceutical and biotechnology drug manufacturers are responsible for identifying and quantifying extractables and leachables and for evaluating any associated potential toxicity. Drug delivery device components are typically made of materials, such as polymers and elastomers. The measurement of extractables from materials that are in contact with drug product is growing in importance due to increased regulatory scrutiny from organizations, such as the FDA. Regulators are concerned about the interaction of the drug delivery device components with drug products. Extractables assessment of plastic and elastomeric components forms an integral part of the submission for approval, as well as for the routine controls used to release batches of the drug product.
Aptar Pharma manufacturing sites in
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