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Nitrosamine Risk Assessment - Toxicology - QbD Group

Nitrosamine Risk Assessment

Are you currently dealing with the complex challenges of managing the regulatory requirements for nitrosamine impurities in your pharmaceutical products?

At QbD Group, we specialize in nitrosamine risk assessments, helping pharmaceutical companies like yours identify risks, write reports, calculate acceptable limits, and address any regulatory agency responses or concerns.

Let us be your partner in safeguarding quality and regulatory compliance.

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What is nitrosamine risk assessment?

Nitrosamine Risk Assessment is a thorough evaluation of drug product manufacturing processes, aimed at identifying and mitigating risks associated with nitrosamine impurities. It involves analyzing:

  • Raw materials and excipients

  • Manufacturing equipment and processes

This process adheres to global regulatory guidelines, such as those outlined by the EMA and FDA, ensuring that all detected levels of nitrosamines remain within acceptable limits. It is an essential requirement for Marketing Authorization Holders (MAHs), API manufacturers, drug product manufacturers, and suppliers of raw materials and excipients.

Why is it important?

Nitrosamine impurities are a significant safety concern due to their high carcinogenic potential, classifying them as a "cohort of concern" among mutagenic impurities. 

Pharmaceutical companies must identify, assess, and mitigate the risks of nitrosamine contamination to comply with global guidelines (EMA, FDA, ICH) and avoid costly recalls, non-compliance penalties, or product delays

These impurities are subject to ongoing regulatory review, as the issue is relatively recent and new data continues to emerge from the scientific and regulatory community to enhance our understanding.

 

Discover how QbD Group can help
Nitrosamine Risk Assessment - Toxicology - QbD Group (3)

 

How can we help?

No matter what your nitrosamine risk assessment (NRA) needs are, we have different services to support you:

Risk assessment

Risk assessment

Comprehensive evaluation of manufacturing processes, addressing all risk factors and root causes outlined in EMA and FDA guidelines. Updates to the NRA as new information arises that needs to be reflected in the report.

Acceptable limits calculation

Acceptable limits calculation

Assistance with determining acceptable limits based on acceptable intake (AI) calculations for nitrosamine impurities identified as potential risks. Covers nitrosamines listed by EMA and FDA, as well as unknown nitrosamines. Includes support for CPCA AI establishment and exploring different options for acceptable intake determination. 

Review of NRA reports

Review of NRA reports

Evaluation of NRA reports prepared by other companies or documentation related to nitrosamine impurities in pharmaceutical components to ensure compliance with regulatory agency requirements. 

Expert support

Expert support

Support in implementing actions derived from the outcomes of the Nitrosamine Risk Assessment, ensuring proper controlling steps are taken to address identified risks effectively. 

Priority strategies

Priority strategies

Analysis of manufacturing processes for various drug products to identify those most susceptible to nitrosamine impurity risks and propose priorization strategies

Nitrosamine toxicological assessment report

Nitrosamine toxicological assessment report

Toxicological evaluation, including a review of genotoxicity/carcinogenicity data and establishment of acceptable intake using the TD50 value of a surrogate with sufficiently robust carcinogenicity data as a point of departure for AI derivation through SAR and read-across methodologies.
Nitrosamine Risk Assessment - Toxicology - QbD Group (1)

Our process

  1. Initial consultation: understand the client’s specific needs and regulatory concerns.
  2. Data collection: gather necessary documentation on the drug product's manufacturing process, including statements and questionnaires from component manufacturers.
  3. Risk assessment report: prepare a Nitrosamine Risk Assessment (NRA) report, identifying potential sources of nitrosamine contamination as outlined in the EMA and FDA guidelines.
  4. Report delivery: provide a comprehensive report detailing the outcome, indicating whether there is a risk or no risk of nitrosamine presence in the manufacturing process.
  5. Follow-up support: offer ongoing assistance, including acceptable limit calculations to establish appropriate detection limits for confirmatory testing, if required. 
Get in touch to discuss your specific needs

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

What are nitrosamines, and why are they a concern?

Nitrosamines are chemical compounds that may pose a cancer risk. Regulatory agencies require their presence in pharmaceutical products to be minimized or eliminated. 

What products require these evaluations?

According to EMA: MAHs/Applicants of all human medicinal products shall assess the risk of presence nitrosamine impurities in their API(s) and FP(s). 

How long does the risk assessment take?

Depending on complexity, assessments typically take 4-8 weeks.

What happen if there is a risk of presence of nitrosamine impurites in my drug product?

If a risk of nitrosamine impurities is identified, the first step is to perform confirmatory testing to experimentally determine the levels of nitrosamines in the product. Depending on the results, appropriate actions will be taken. 

What regulatory guidelines do you follow?

We adhere to EMA and FDA guidelines specific to nitrosamines, ICH Q9 principles for risk assessment, ICH M7, and other global regulations related to nitrosamine risk management. 

Is it possible to mitigate risk of nitrosamine impurities using QSAR based strategies?

No, in-silico data is not currently accepted for determining limits or assessing the extent of nitrosamine formation.

 

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Ready to take te next step?

Let QbD Group help you address the complexities of nitrosamine risk management. Contact us today.

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