Nitrosamine Risk Management

Nitrosamines in batches of products containing Sartan derivative, Ranitidine or Metformin are a cause of concern.

Regulatory agencies expect you to submit a Risk Evaluation Report as well as an action plan to deal with identified risks.

To support you with this, 4TE delivers Quality Risk Management Optimisation built on top of our Consultancy services and QRM digital platforms.


Talk to our experts

Nitrosamine Risk Management

Nitrosamines in batches of products containing Sartan derivative, Ranitidine or Metformin are a cause of concern.

Regulatory agencies expect you to submit a Risk Evaluation Report as well as an action plan to deal with identified risks.

To support you with this, 4TE delivers Quality Risk Management Optimisation built on top of our Consultancy services and QRM digital platforms.


Talk to our experts

Timely answer to Regulatory Requirements

Assurance of Zero Warning Letters about Nitrosamines

Integrated support for Nitrosamines: Risk Evaluation, Confirmatory Testing and Regulatory Submission

Avoid Recalls and Reputation Loss

Nitrosamines = challenges

Identifying and mitigating the risks of nitrosamine impurity presence in pharmaceutical and biopharmaceutical products is now a demand. FDA's Process Analytical Technology Guidance for Industry

And this means challenges. It can be challenging to structure a risk-based approach to evaluate nitrosamine presence, it can be challenging to map and analyse the risks and, even more so, it can be challenging to define and implement the actions resulting from those Risk Assessments.

We can help in all parts of this process.

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Managing your Nitrosamine concerns

We believe in an integrated approach to deal with Nitrosamines based on the 3-Step approach defined by the European Medicines Agency, the guidance of US Food and Drug Administration and ANVISA (Brazil).

We will start by prioritising your products using a risk-based approach. From there, we will conduct a risk evaluation to identify the active substances and finished products at risk of N-nitrosamine formation or (cross-)contamination.

From there, in case a risk has been identified, we will proceed with confirmatory testing according to product prioritisation. If Nitrosamine presence is confirmed, we will assess the immediate risk for patients.

Finally, if it is necessary, we will support designing and optimising the changes in the manufacturing process and support on the preparation of the necessary documents to request for a variation to the marketing authorisation near the relevant regulatory agencies.

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Working with us will yield results.

Whether you have already started managing the Nitrosamine Risks or you are the early stages of the process, our Quality Risk Management specialists can support on your Nitrosamine Risk Management, by:

  • Fully mapping the risks associated to Nitrosamine contamination as well as a monitoring and control plan to make sure they do not escalate.
  • Applying pre-defined state-of-the-art protocols for swift Quality Risk Management Assessment.
  • Assuring confirmatory testing as well as the definition of the action plan to deal with eventual contaminations.
  • If there is a need for a manufacturing process change, we will develop it using a QbD (Quality by Design) framework. We will either deliver a tailor-made solution or an integrated approach based exactly on what you need.

Our work on this topic

Nothing shows our experience better than our work on this topic. Here you can find the resources we have produced on Nitrosamine Risk Management so far.

The solutions we work with

consulting irisk riskregister isee

What can you expect when you work with us

  • We will have a Pre-project meeting so that we can understand your expectations in the short and medium-term.
  • When everything is lined-up, and if you are happy, we will enter into contract.
  • Our teams will meet to formalize the project kick-off, covering the project scope, schedule, milestones, deliverables, and anything else that is necessary.
  • We will install any necessary software that we may have agreed before.
  • If that's the case will define Software training dates for your team in order to make sure you can make the most out of Risk Management Digitalization.
  • We will provide you support and follow-up during our partnership.
software-print

Let's make sure Nitrosamines are not an issue with your Process