Several trends in analytical testing follow new regulatory requirements, including the implementation of the International Council for Harmonization’s (ICH) Q3D Elemental Impurities guideline, and more recently, ICH M7 – the purpose of which is "to provide a practical framework that is applicable to the identification, categorization, qualification, and control of [mutagenic impurities] to limit potential carcinogenic risk," according to the guideline.
Additionally, the United States Pharmacopeial Convention’s (USP’s) requirements for controlling elemental impurities set out in USP <232> and USP <233> provide analytical methods and validation criteria that will be enforced beginning January 1, 2018.
In response to these regulatory changes, AMRI is offering its impurity solutions as a stand-alone service, which “opens up opportunities for other prospective customers, extending to them our years of impurity-focused process knowledge for chemical compounds,” said John Iannone, director, extractables/leachables and impurities.
“This will more thoroughly and accurately help them understand impurity control requirements from a toxicological perspective to ensure the safety and efficacy of our customers’ products and improve drug development efforts,” Iannone told Outsourcing-Pharma.com.
The contract research, development and manufacturing organization's (CDMO) analytical services include a range of solutions, which Iannone said are designed to satisfy various industry and regulatory requirements.
“Through the years, AMRI has gained a wealth of knowledge and expertise working on a variety of projects as a CRO/CDMO,” he added.
“As a result of working with so many different kinds of customers and projects/products, we have the ability to leverage an extraordinary and diverse database of mass spectral data and methods for analyzing extractables/leachables and impurities, which enables us to better detect and measure these trace compounds.”