FDA Publishes Guidelines for Elemental Impurities in Drug Products

On June 30, 2016, the FDA released updated guidelines for Elemental Impurites in Drug Products.  The update coincides with USP’s recent harmonization of Elemental Impurities within General Chapters 232 and 233.  At FDA’s recent conference, implementation of these guidelines were reviewed in detail, from Risk Assessment through testing strategies. Should you require guidance in implementing… Read More >

USP Updates General Chapter <232>

USP has posted updates to USP General Chapter <232> Elemental Impurities. This chapter is being revised to address comments received and to further align this chapter with ICH Q3D. USP’s Elemental Impurities Expert Panel approved a recommendation to the General Chapters—Chemical Analysis Expert Committee that this chapter be revised to align with the ICH Q3D… Read More >