| DOI: 10.29090/psa.2024.03.24.1854 | Pharm Sci Asia 2024; 51(3), 190-203 |
Nitrosamine Impurities in Pharmaceuticals: Regulatory Landscape and ChallengesVaidehi Bhangale*, Anita Ayre
- Department of Quality Assurance, Vivekanand Education Society’s College of Pharmacy (Autonomous), Chembur (E), Mumbai, Maharashtra, India
Nitrosamines have drawn considerable attention due to their recognized health risks, notably their association with carcinogenic effects. Ongoing research is dedicated to advancing our understanding of nitrosamines, focusing on their formation mechanisms, detection methods, and potential strategies for mitigation. The current review centers on the factors and origins of nitrosamine generation, exploring regulatory dimensions governing their control, assessing the challenges inherent in nitrosamine regulation, and delineating the prospective avenues for enhancing nitrosamine control measures in the future. Key aspects include a focus on risk assessment and mitigation, with experts stressing the importance of thorough assessments to identify potential sources of nitrosamine contamination. Mitigation strategies involve making changes in manufacturing processes, carefully selecting raw materials, and implementing robust analytical testing protocols. Communication and transparency are deemed crucial, with experts emphasizing the need for clear guidelines, regular updates, and effective communication channels to enhance understanding and compliance.
Keyword:
Pharmaceuticals; Drug, Nitrosamines;, Origin;, Regulation; Challenges; Mitigation
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