The International Conference on Harmonisation (ICH) Q3D guideline aims to provide a risk-management process to assess and control elemental impurities in drug products.1
As a consequence, the way in which pharmaceutical manufacturers and their suppliers will be required to test active pharmaceutical ingredients (APIs), raw materials and excipients will change considerably.
Although the final guidance provides a platform for manufacturers to develop a risk-based control strategy, it also presents many challenges. The industry is debating whether the new guidance is creating unnecessary barriers to product innovation — is it simply looking for problems that don’t exist? Even so, with deadlines on the horizon, manufacturers now need to look towards the introduction of technologies and analytical testing methods that are able to meet new requirements.
Fergus Hall, PhD, Section Manager, Pharmaceutical Chemistry at Eurofins BioPharma Product Testing, shares his insight on the impact of emerging guidance and how techniques such as Inductively Coupled Plasma Mass Spectrometry (ICP-MS) are going to prove critical in overcoming the potential hurdles.
Introducing ICH Q3D
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