Drug Logix India Private Limited provides comprehensive, science-driven Potential Mutagenic Impurities (PMI) Assessment Services to support pharmaceutical companies in identifying, evaluating, controlling and mitigating potential mutagenic and genotoxic impurities throughout the drug substance and drug product lifecycle.
Our assessments provide a scientifically justified evaluation of potential mutagenic impurities associated with drug substances, drug products, starting materials, intermediates, process-related impurities, degradation products and other materials used in pharmaceutical manufacturing.
They are designed to support compliance with ICH M7 – Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, together with relevant regulatory expectations and scientifically justified risk-management principles.
Request a PMI AssessmentWe provide an end-to-end scientific and regulatory assessment covering potential mutagenic impurities associated with:
Our approach combines process understanding, chemical structure assessment, literature evaluation, computational toxicology/QSAR assessment and regulatory risk assessment to develop a scientifically justified impurity control strategy.
We review the complete synthetic route of the API to identify chemical transformations and process steps that may potentially generate or introduce mutagenic impurities. The assessment may include:
Our scientific team systematically evaluates chemicals used or generated throughout the manufacturing process to identify substances requiring further mutagenicity assessment. Potential hazards are evaluated based on:
Where appropriate, we perform in-silico (QSAR) assessments using complementary computational approaches to evaluate the potential mutagenic hazard of relevant compounds. The assessment can include:
Results are critically reviewed rather than relying solely on an automated prediction outcome.
Potential impurities are scientifically evaluated and classified according to the principles of ICH M7, considering available experimental and computational evidence. Depending on the available data, impurities may be evaluated for:
We prepare comprehensive, scientifically justified Potential Mutagenic Impurity Assessment Reports suitable for internal quality and regulatory review. Reports may include:
Where a potential mutagenic impurity is identified, we assess its relevance to the manufacturing process and provide scientifically justified recommendations regarding:
This helps clients establish a science- and process-based control strategy rather than relying solely on theoretical hazard identification.
Our services can support pharmaceutical companies during:
To conduct a comprehensive assessment, clients may provide:
Drug Logix India Private Limited combines pharmaceutical process understanding with scientific and regulatory expertise to provide practical, risk-based mutagenic impurity assessments. Our focus is not only on identifying potential hazards, but also on understanding their process relevance, likelihood of formation or carryover, purge potential and appropriate control strategy.
Drug Logix – Science-Driven Regulatory Support for Mutagenic Impurity Risk Assessment.
The final deliverable is a comprehensive Potential Mutagenic Impurities Assessment Report containing the scientific rationale, supporting computational and literature evidence, ICH M7-based assessment, risk classification and appropriate recommendations for impurity control.