Avoid Another Elemental Impurity Meltdown – Read the Final Guidance

After a disastrous start to the new year and the significant slowdown in approvals resulting from the OGD’s strict application of the provisions of the USP Elemental Impurity Chapter while awaiting harmonization with ICH Q3D, the approvals have begun flowing again.  There are some changes in the final guidance (here) from the draft that the FDA made in the harmonization effort.  Prior to issuance of the draft guidance, USP <232> included a fraction (15) of the Elemental Impurities (EIs) listed in ICH Q3D.  In addition, a number of stakeholder comments requested clarification regarding the applicability of the guidance to Biologics License Applications (BLAs).  The final guidance now states that “for control of EIs in approved or pending BLAs, see ICH Q3D.”  This differs from the draft, where it was stated that the guidance pertained to biotechnology products covered by New Drug Applications (NDAs).

The USP also introduced new limits and modern analytical methods for detecting EIs.  The guidance goes on the discuss FDA expectations for prescription drug products not marketed under an approved application.

This should help NDA and ANDA applicants meet the EI requirement and help prevent another approval drought as seen after the January 1, 2018 implementation of the USP requirements.