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Services - Toxicology - Elemental Impurities Reports - QbD Group

Elemental Impurities Reports

Are you navigating the complexities of elemental impurities compliance?

At QbD Group, we specialize in providing comprehensive risk assessments and reports for human and veterinary pharmaceutical products. Our team of expert toxicologists ensures that your products meet regulatory requirements by identifying risks, preparing tailored assessments, and addressing agency feedback with precision.

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What is Elemental Impurities Risk Assessment for Toxicology?

Ensuring compliance with elemental impurities regulations starts with a thorough risk assessment of your pharmaceutical manufacturing processes. At QbD Group, we guide you through the four essential steps of risk assessment:

  1. Identifying potential sources of elemental impurities.
  2. Analyzing the elements introduced by each contamination source.
  3. Evaluating actual or predicted levels against established Permitted Daily Exposure (PDE) values.
  4. Defining a control strategy based on the results.

Our expert team ensures a comprehensive approach to help you meet regulatory standards while safeguarding product quality and patient safety.

Why control of elemental impurities matters

Elemental impurities offer no therapeutic benefit and must be controlled within acceptable limits, as outlined in ICH Q3D guidelines. Manufacturers and Marketing Authorization Holders (MAH) are required to develop a control strategy based on a thorough risk assessment to manage the potential risks of impurities in drug products.

This risk management process is essential for:

  • Meeting regulatory requirements for Marketing Authorization Applications (MAA).
  • Ensuring compliance during GMP inspections at manufacturing sites.

A documented repository of updated elemental impurities risk assessments is mandatory for audits and inspections. These reports must also be included in registration dossiers as part of the regulatory submission process.

From consultation to compliance: our step-by-step process

Our structured approach ensures a seamless and compliant evaluation of elemental impurities in your drug products.

Here’s how it works:

Initial consultation
We begin by understanding your specific needs and regulatory concerns to tailor our approach to your product.

Step 1

Data collection
We gather all necessary documentation, including manufacturing process details and statements or questionnaires from component manufacturers.

Step 2

Risk assessment report
Using EMA and FDA guidelines, we prepare a detailed risk assessment report, identifying potential contamination sources and assessing risks.

Step 3

Report delivery
You receive a comprehensive report outlining observed or predicted impurity levels, their comparison to PDE values, and whether additional controls are needed.

Step 4

Follow-Up support
We provide ongoing assistance, including acceptable limit calculations and detection limit recommendations for confirmatory testing, ensuring continued compliance.

Step 5

Why QbD Group?

  • End-to-end toxicology support
    From early development to post-approval changes, we provide integrated risk assessments seamlessly aligned with QA, CMC, and regulatory strategies.
  • Trusted expertise at scale
    With decades of combined experience across diverse projects and markets, our toxicology team provides reliable insights that add efficiency, consistency, and confidence to every assessment.
  • Proactive compliance monitoring
    Through strict oversight of reports, we help clients stay in full control of toxicology obligations, proactively alerting them to potential non-conformities before they become risks.
  • Certified Toxicology Experts 
    Our reports are prepared and reviewed by EUROTOX-certified (ERT) toxicologists, ensuring the highest standards of scientific quality, regulatory reliability, and patient safety across every assessment.


    EUTOTOX
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End-to-end toxicology support

10+ years of experience

Compliance monitoring

Certified toxicology experts

 

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Have questions about our Elemental Impurities Risk Reports offering?

If you need more information or support with your elemental impurities reports, our toxicology experts are ready to help. Simply fill out the form, and we’ll provide the guidance you need to ensure compliance and safeguard product quality.

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