Are we there yet?
Testing our pharmaceutical drugs for elemental impurities by Induced Plasma Spectroscopy has been a topic of intense discussion since early 2009 when the International Conference of Harmonization (ICH) commenced work to provide global standards. These standards seek to identify and eliminate elemental impurities in drug products and the ingredients that make up these products. In December 2014, the ICH finalized Q3D, the Guidelines for Elemental Impurities. Since then the USP has updated its own colorimetric test to utilize the scientific advancement of ICP-OES and ICP-MS technology. The USP method is to be enforced on January 1st 2018 and can be employed instead of the previous method now.
While both ICH Q3D and USP General Chapters <232> and <233> are scheduled to go into effect in 2018, FDA says it encourages manufacturers to comply with the standards as early as possible, as they "provide significant improvements over existing approaches."
"In general, FDA recommends that the manufacturer of any US marketed drug product follow ICH Q3D recommendations to establish appropriate procedures for identifying and controlling elemental impurities in the drug product based on risk assessment and product-specific considerations," FDA writes.
The majority of all active pharmaceutical ingredients OTCs and dietary suppliments sold in the U.S. are manufactured outside the United States. This increase in globalization has exponentially raised the concern for the drug market. US companies have already begun the procurement and implementation of USP 232 and 233. But time is running out.
“It will take 3-6 months to get the right instrumentation, 3-6 months to develop the competence in elemental analysis, and 3-6 months to validate the methodology,” claims Rob Thomas.
Rob has served on the ACS Reagent Chemical Committee for the past 14 years and has worked closely with the USP to align the testing procedures for elemental impurities in ACS reagent chemicals with those of pharmaceutical and nutraceutical materials.