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.

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:

Identifying potential sources of elemental impurities.
Analyzing the elements introduced by each contamination source.
Evaluating actual or predicted levels against established Permitted Daily Exposure (PDE) values.
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.

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?

For more than 10 years, QbD Group has been a trusted partner in Toxicology Services, providing expert advice and support to mitigate and control quality risks across the life sciences industry.

Our Toxicology Team holds membership in AETOX, a benchmark organization in toxicology.
Our experts are certified by EUROTOX, ensuring we meet the highest professional standards.

Whether you need comprehensive PDE reports or expert toxicological support, QbD Group is ready to help you ensure safety, quality, and compliance in every step of your operations.

AETOX EUTOTOX

10+ years of experience

Full lifecycle support

Global presence

Best Managed Company

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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.