ICH Q3D Could Provide Model for More Inclusive ICH Process; Focus Continues on Q3D Implementation Challenges, Including Risk Assessments

The development and implementation of the ICH Q3D guideline on elemental impurities could provide a model for a more inclusive ICH process.

In addition to the three agency and three association members from the US, Europe and Japan, several other stakeholders have played an important role in addressing the challenging issues involved and assuring the broad viability of Q3D as it emerges from the ICH pipeline.  Prominent among them have been the US, European and Japanese Pharmacopeias, the regulatory agencies from China, Taipei, Korea, Canada, Switzerland, and industry groups such as the International Pharmaceutical Excipients Council (IPEC). Health Canada and Swiss Medic are voting members on the ICH steering committee.

At a conference co-sponsored by the Product Quality Research Institute (PQRI) and FDA on “evolving product quality” held in mid-September in Washington, D.C., Novartis Analytical Science and Technology Group Quality Operations Global Head Mark Schweitzer highlighted the broad stakeholder involvement in the Q3D expert working group (EWG) and the benefits of that participation.  Schweitzer was the industry rapporteur for ICH Q3D through Step 2.

“I think it worked,” he said, “because we got a better view of the issues and global concerns” that the guideline addresses as well as the significant challenges in its implementation.

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