Lhasa Limited is pleased to announce the release of Vitic Q3D, an innovative in silico tool designed to harmonise ICH Q3D assessments using proprietary elemental impurities data. This cutting-edge tool utilises an expert-curated, proprietary database to identify impurity sources in APIs and excipients. It has been designed to support risk assessments, develop control strategies, and ensure regulatory compliance.
Developed by Lhasa experts in collaboration with industry leaders, including those from the top 20 pharmaceutical companies, the Vitic Q3D tool was driven by members of Lhasa’s Elemental Impurities data sharing initiative.
The solution supports pharmaceutical companies by performing automated elemental impurities assessments, utilising a curated, high-quality elemental impurities database hosted within Lhasa’s structure-searchable toxicity database Vitic. As a result, Vitic Q3D reduces the need for in-house analytical testing, and streamlines the Q3D assessment workflow by providing a centralised data management system.
Information on the latest Lhasa Elemental Impurities Database update can be found here.
The main motivation behind the development of Vitic Q3D, has been to aid the multidisciplinary approach required for Q3D assessments:
- The identification of impurity sources.
- Development of control strategies according to their toxicity class and permitted daily exposure (PDE) limits.
- Compliance with regulatory expectations.
Leveraging both their own in-house data and the tool’s proprietary database, users can build and generate automatically populated reports with mandatory elemental impurities for assessment within their APIs and excipients.
Agnieszka Ceszlak, Associate Director within Science at Lhasa, has described the anticipated impact of Vitic Q3D:
“The Vitic Q3D tool aligns with our mission to enable informed decisions on chemical safety, and we are thrilled that it has been the result of collaboration between pharmaceutical companies and Lhasa Limited. We are confident Vitic Q3D will support control strategy development, enhance product quality, and benefit both industry and regulators.”
Dr Adrian Fowkes, Director of Science at Lhasa, added:
“Our intention with Vitic Q3D is to transform ICH Q3D assessments, with its automated elemental impurities evaluations and proprietary database, making workflows smoother and ensuring regulatory compliance. This software will not only support control strategy development and enhance product quality, but also significantly reduce the need for in-house analytical testing, paving the way for a more efficient and reliable process.”
For more information on the software, visit the Vitic Q3D assessment page. Interested in a free demonstration? Get in touch with Lhasa’s expert team here.