“This new date is intended to align the implementation of General Chapter <232> more closely with that of the ICH Q3D Guideline for Elemental Impurities,” USP said in the announcement.
Mario Sindaco, Director, Compendial Affairs and Executive Secretariat, Council of Experts at USP, told In-Pharmatechnologist.com that USP published a revision to General Chapter <232> “that indicated partial alignment with Q3D.” USP says it intends to further align its general chapters with ICH.
In October, the USP Elemental Impurities Expert Panel met and approved a recommendation that the limits included in the chapter “be revised to align with the ICH Q3D Step 4 document to the extent possible.” This recommendation was informed by stakeholder feedback and the final version of <232> reflecting these changes “will be made available on our website as soon after its approval by the Expert Committee as possible,” Sindaco told us.
Finalized last month, ICH’s Q3D lays out 24 elements that need to be evaluated by manufacturers, including the mercury, lead, cadmium and arsenic, and sets the 2018 deadline.
USP initially set a May 2014 deadline for the general chapters to be implemented by industry, though some expressed concerns that the USP standards might be different from what was being proposed at the ICH and that USP was jumping the gun as the EU and Japanese Pharmacopeia said they would wait on ICH.
And in April 2014, IPEC (International Pharmaceutical Excipient Council) sent a letter to industry requesting feedback on the impurity general chapters, which seemed to indicate industry wasn’t prepared for the impending deadline.
Sindaco told us feedback to USP from industry “has been varied,” though he noted that the feedback “has helped to inform our proposed implementation approach.
“I personally am not aware of any companies that will not be able to meet the 2018 deadline, but USP has acknowledged our willingness to work with manufacturers and FDA where compliance for specific products is challenged,” Sindaco added.