It is our responsibility as a CRO/CDMO tocombine our extensive knowledge with our high-end resources to ensure the safety and efficacy of ourcustomers’ products and improve drug development efforts
October 12, 2017
AMRI, a global contract research, development and manufacturing organization that partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life, will now be offering its impurity solutions as a stand-alone service. Several trends in analytical testing are being attributed to new regulatory requirements for all new drug products, including the finalization of ICH M7 earlier this year and the upcoming required compliance of USP 232 and USP 233 by January 1, 2018. ICH M7 provides a practical framework applicable to the identification, categorization, qualification, and control of these mutagenic impurities to limit potential carcinogenic risk and USP 232 and USP 233 provides direction related to Elemental Impurities-Limits and Procedures, aligning requirements mostly with the ICH Q3D.
“Offering our impurity solutions as a stand-alone service – beyond providing them as an accompanying service to AMRI’s Discovery & Development services, or API and Drug Product programs – will enable us to extend our comprehensive expertise, purpose-built technologies and resources to our customers for impurity assessments and control,” said John Iannone, director, extractables/leachables and impurities, AMRI. “We are committed to excellence and to being a true partner to the industry. It is our responsibility as a CRO/CDMO to combine our extensive knowledge with our high-end resources to ensure the safety and efficacy of our customers’ products and improve drug development efforts.”