Consortium Grows As Drugmakers Share Excipient Metal Impurities Data To Ease ICH Q3D Testing Burden
More manufacturers are contributing their analytical data to an excipient database to pool knowledge on the risk posed by excipients that may cause drugs to exceed acceptable PDE levels under ICH Q3D.
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The pharmaceutical industry is developing an excipient database to better enable industry to conduct risk assessments set out in the ICH Q3D guideline.
The US FDA tells manufacturers in two recent warning letters to get to the root cause of contamination problems and take a more proactive approach to cleaning and equipment maintenance.
Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.