New Guideline on Elemental Impurities and its implications

The ICH recently published the guideline ICH Q3D to control elemental impurities, which will have a huge impact on the control strategy of metal and other inorganic impurities for drug products worldwide. The EMA announced that the new requirements will come into effect in Europe in June 2016 for new drug products and December 2017 for authorized drug products. Other regions, including the U.S. and Japan, have not yet announced the transitional period.

ICH Q3D requires drug product manufacturers to prepare a risk assessment and develop controls for elemental impurities specifically for drug products. All sources of contamination of elemental impurities in the final drug product need to be considered.

How can Merck help?

According to the guideline, suppliers of drug substances and excipients can help facilitate risk assessment by providing information about the potential elemental impurities. Merck is currently compiling supportive information on elemental impurities in pharmaceutical starting materials, in a step-by-step process for our EMPROVE® product range.
We also invite you to join our upcoming webinar on March 5, in which we will cover the scope of the guideline, discuss its impact on drug product and pharmaceutical starting materials, and present a risk-based approach for assessment and control of elemental impurities.

For more information or to register, please click the button below.

For more information, please click here

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