Extractables & Leachables Reports

Managing risk assessments reports or toxicological evaluations for extractable and leachable impurities is no small task. Whether you're determining the safety of materials used in manufacturing or assessing the impact of packaging, accuracy and compliance are essential—not just to meet regulations but to uphold the integrity of your product.

At QbD Group, we provide toxicological assessments and risk evaluations designed to fit your specific needs. Our customized approach ensures compliance with the standards of various regulatory bodies.

What are extractables & leachables reports?

The risk and toxicological assessment of extractable and leachable impurities is a crucial process in the pharmaceutical industry to ensure the safety and quality of products.

These impurities, which can migrate from packaging materials or medical devices into the final product, represent a potential risk to patients.

As a result, regulators such as the FDA and EMA require detailed reports to support the safety of drugs and medical devices against the presence of impurities from materials used in manufacturing processes or packaging

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How can we help?

Our team of toxicologists and analytical chemists work together to perform in-depth analyses, risk assessments, and toxicological evaluations. We provide customized reports that meet the specific regulatory requirements for each pharmaceutical product and client.

Risk assessment

Thi service entails the analysis of possible compounds released from drug contact materials, assessing their impact on safety, determining whether these impurities are within safe limits.

Toxicological evaluation

This evaluation is for all impurities outside the limits established after risk assessment. This report provides a compilation of the harmful effects of impurities, determining their toxicity and health risks. QSAR methods can be used to perform this assessment to help establish safe exposure limits and ensure product safety.

Extractables & Leachables Reports- Toxicology - QbD Group

Why QbD Group?

We have a specialized, multidisciplinary team of toxicologists and analytical chemists with extensive experience in the assessment of extractables and leachables.
We perform detailed analyses, toxicological studies, and prepare customised reports according to the specific regulatory requirements and needs of each client.
We offer an approach that combines in-depth technical knowledge with a detailed understanding of international regulations, ensuring customized and rigorous reports.
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.

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Why are extractables and leachables studies important?

These studies are essential to ensure that impurities do not compromise the safety, efficacy, or quality of the product, while also meeting international regulatory requirements.

What regulations apply to extractables and leachables?

FDA, EMA, USP 1663, USP 1664, and ICH Q3E guidelines require rigorous evaluations of these impurities.

When should extractables and leachables studies be performed?

They should be conducted during product development and before commercialization.

What products require these evaluations?

All pharmaceutical products in contact with plastics, rubber, metals, or other packaging and device components.