Genotoxicity Assessment of Impurities and their classification as per ICH M7

Our Mutagenicity Assessment Service, compliant with ICH M7 guidelines, utilizes state-of-the-art computational toxicology to predict the mutagenicity of impurities in pharmaceutical compounds. This service is essential for companies aiming to ensure the safety and quality of their products while adhering to regulatory standards.

Why Mutagenicity Assessment?

  • Mitigating Risk: Identifies chemical compounds (impurities) that could cause DNA damage, crucial for maintaining the safety and quality of pharmaceuticals.
  • Regulatory Compliance: Necessary to meet regulatory guidelines that demand control of such impurities at low levels.
  • Ensuring Product Safety: Helps ensure the quality and safety of pharmaceutical products, protecting patient health.

Our Comprehensive Mutagenicity Assessment Service

  • Comprehensive Mutagenicity Assessment: Employing (Q)SAR methodologies for accurate prediction and classification of genotoxic impurities.
  • Regulatory Submission Support: Providing detailed reports including classification of impurities, scientific rationale, and support for regulatory submissions.
  • Expert Summary: Offering an expert summary that outlines the classification of impurities and provides a scientific rationale based on computational toxicology.

Why Choose Veeprho?

  • Regulatory Compliance: Our service is specifically designed to meet the stringent requirements of ICH M7, ensuring your pharmaceutical products comply with global regulatory standards for genotoxic impurities.
  • Expertise in Computational Toxicology: Leverage the expertise of our team in computational toxicology to gain insights into the genotoxic potential of impurities, facilitating informed decision-making and strategic planning.
  • Efficiency and Cost-Effectiveness: (Q)SAR methodologies provide a rapid and cost-effective alternative to traditional mutagenicity testing, reducing the need for extensive laboratory testing without compromising on accuracy or reliability.
  • Tailored Support: From the initial assessment to the final regulatory submission, we offer tailored support to address your specific needs, ensuring a seamless and successful evaluation process.

Frequently Asked Questions

What is Mutagenicity?

  • The risk posed by chemical compounds (impurities) that cause DNA damage.

Why Perform a Mutagenicity Assessment?

  • Regulatory guidelines require such impurities in pharmaceutical compounds to be controlled at low levels to ensure product safety.

Benefits of Mutagenicity Assessment?

  • Helps ensure the quality and safety of pharmaceuticals, critical for protecting public health.

Consequences of Skipping Mutagenicity Assessment?

  • Failure to perform appropriate assessments can result in 483s or warning letters from health authorities due to unacceptable levels of mutagenic impurities.

Do Pharmacopoeia Impurities Require Assessment?

  • Yes, all impurities related to APIs and formulations, including process-specific and pharmacopeial impurities, need to be assessed.

Classification of Impurities?

  • QSAR analysis allows for the classification of impurities as genotoxic or non-genotoxic based on their structural alerts.

Impact of Classification on QA and Regulatory?

  • Impurities classified as genotoxic require strict quality control measures. Regulatory submissions must detail the classification of all impurities and their control strategies.

Tools for Mutagenicity Assessment?

  • We use computational assessment tools for QSAR analysis as per ICH M7 requirements, including statistical and expert rule-based analyses.

Interpretation and Conclusion?

  • Every report is provided with a classification, justification, and conclusion for all listed impurities, supporting quality assurance and regulatory compliance.

Our Approach

Our mutagenicity assessment process is grounded in a thorough understanding of the chemical structure of impurities, leveraging (Q)SAR models to predict their potential genotoxic effects accurately. This approach is complemented by our team’s expertise in computational toxicology and regulatory requirements, ensuring a comprehensive assessment that supports your product’s safety and compliance.

Contact Veeprho For Mutagenicity Assessment Services

To learn more about how our Mutagenicity Assessment Service can support your pharmaceutical development and manufacturing processes, contact us today. Our experts are ready to assist you in navigating the complexities of ICH M7 compliance and ensuring the safety of your products.

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