Vitic Q3D

Vitic Q3D is an in silico software solution developed by Lhasa Limited for conducting elemental impurity assessments in accordance with the ICH Q3D guideline. It is designed for pharmaceutical scientists and regulatory affairs professionals involved in drug substance and drug product development who need to identify elemental impurity sources in APIs and excipients and establish robust control strategies without relying solely on costly and time-intensive analytical testing.

As part of Lhasa Limited's broader suite of impurity and degradant control tools, Vitic Q3D leverages an expert-curated elemental impurities database to streamline risk assessment workflows and support regulatory submissions throughout the product lifecycle.

Key Capabilities

• Access to an industry-trusted elemental impurity database: Users can draw on both a public and proprietary database curated by industry suppliers via the former Lhasa Elemental Impurities data sharing initiative. This comprehensive database can be used alongside an organisation's own in-house data, reducing the need for extensive analytical testing programmes.
• Automated impurity identification and control strategy development: Vitic Q3D provides a simple step-by-step interface with automated impurity suggestions for APIs and excipients. The software simultaneously generates automated calculations for ICH Q3D options 1, 2A, and 2B to help guide appropriate control options for the drug product.
• Regulatory-ready report generation: The software produces comprehensive reports formatted for ICH Q3D submission. Users can attach supporting documents and expert review notes directly within the platform to facilitate regulatory review.
• Product lifecycle management and reproducibility: Vitic Q3D securely stores all assessments, ensuring that prior evaluations remain accessible and reproducible for future drug re-assessments and ongoing lifecycle management activities.

Regulatory Alignment

• ICH Q3D compliance: Vitic Q3D is specifically designed to support the requirements of the ICH Q3D guideline, which governs elemental impurities in pharmaceutical products. The automated calculation of all three control options (1, 2A, and 2B) ensures that users can efficiently evaluate and document their chosen control strategy in line with regulatory expectations.

Workflow Overview

1. Navigate the step-by-step interface and input your API and excipient information.
2. Review automated elemental impurity suggestions drawn from the curated industry database and your own in-house data.
3. Generate simultaneous calculations for ICH Q3D options 1, 2A, and 2B to identify the most appropriate control strategy.
4. Produce a comprehensive, submission-ready report with supporting documentation and expert review notes attached.
5. Store the completed assessment securely within the platform for future reference and lifecycle management.

Vitic Q3D is offered by Lhasa Limited alongside complementary in silico tools including Mirabilis, for mutagenic impurity purge factor calculations under ICH M7, and Zeneth, for forced degradation pathway prediction under ICH Q3B and related guidelines. Together, these solutions provide an integrated approach to impurity and degradant control across the drug development process.