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.
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.
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
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.
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.
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:
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.
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