The use of nitrosamines in pharmaceutical manufacturing has become a major topic of interest because it is considered a probable carcinogen in humans. All regulators, such as the FDA and EMA, are currently mandating manufacturers to evaluate and mitigate the risk of nitrosamine impurities in both finished drug products and active pharmaceutical ingredients (APIs). Masuu Global provides end-to-end Nitrosamine Impurity Risk Assessment services to assist pharmaceutical firms to meet their regulatory obligations and the safety of their patients around the world.
What Are Nitrosamines?
Nitrosamines refer to a set of chemical compounds that can be formed during the production of drug substances or products whereby particular conditions of secondary or tertiary amines and nitrosating agents take place. N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) are some of the common nitrosamines found in commonly used medications leading to worldwide recalls and enhanced regulatory attention.
The Significance of Nitrosamine Risk Assessment
Long-term exposure to nitrosamine contaminants, even at low concentrations, can have major negative effects on health. Consequently, authorities now demand:- Comprehensive risk analyses for every product that is commercialized or under development.
- Risks are determined by testing and confirmatory analysis.
- mitigation techniques to stop or manage the production of nitrosamines.
- Reputational harm, product recalls, supply chain interruptions, and regulatory action may follow noncompliance.
The Nitrosamine Risk Assessment Services Offered by Masuu Global
Through a methodical, scientific approach to nitrosamine risk assessment and control, Masuu Global assists biotech and pharmaceutical companies. Among our offerings are:- Identification and Assessment of Risks We assess risk variables pertaining to production procedures, storage conditions, packaging materials, excipients, and APIs. We abide by the FDA, EMA, ICH M7(R2), and other regulatory criteria.
- Analysis of the Root Causes We do thorough root cause analyses to determine the source, whether it is connected to raw materials, synthesis processes, or cross-contamination, if nitrosamine production potential is detected.
- Development of Methods and Laboratory Testing With detection limits in the ppb range, we assist in the creation and validation of sensitive analytical techniques for nitrosamine detection, such as GC-MS and LC-MS/MS approaches.
- Strategies for Risk Mitigation and Control We suggest and carry out mitigation strategies based on the assessment, which can include anything from reformulation or changes to packaging systems to process adjustments and raw material control.
- Support for Submissions and Regulatory Documentation We help gather the necessary records for regulatory submissions, such as answers to questions from the Health Authority, risk assessment reports, and explanations of control strategies.
Compliance and Readiness Global
Masuu Global guarantees adherence to the most recent guidelines, which include:- Results of the EMA’s Article 5(3) review
- FDA’s Guidelines for the Control of Nitrosamine Impurities in Human Drugs
- Guidelines for ICH Q3D and M7(R2)
Our team makes sure your risk assessments are both scientifically valid and ready for regulators by staying abreast of changing worldwide requirements.
Why Choose Masuu Global?
Nitrosamine risk evaluations are an investment in patient safety and product quality, not just a legal necessity. You get a partner with extensive technical know-how, regulatory awareness, and workable solutions catered to your product lifecycle stage when you work with Masuu Global.
