Pharmaceutical Manufacturers Grapple With ICH Q3D Implementation
Pharmaceutical manufacturers say that complying with ICH Q3D presents a host of challenges, and that the more difficult task is conducting a risk assessment rather than actual testing for elemental impurities. Companies are finding that they should allow plenty of time for risk assessments.
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A pharmaceutical industry official said while it is not too late, manufacturers that have not yet started risk assessments to comply with ICH Q3D for legacy products need to get busy. Official also advised that good risk assessments should make it easier to comply and reduce the need to retest products if new metals are introduced into the manufacturing process.
Regulatory members of the International Council on Harmonization have issued Q3D guidance on metal impurities that, while harmonized, differs in emphasis.
One pilot target domestic manufacturers of finished drugs and another foreign manufacturers of APIs. As an incentive to participate, companies assigned high scores will be accorded regulatory flexibility. Also, participants that disclose facility ratings could “benefit from a competitive advantage.”