"The presence of the Nitrosamine Impurities in API’s has resulted in several regulatory warnings and recall of contaminated products. Global regulatory authorities such as FDA, MHRA and EMA have instructed all pharmaceutical manufacturers to conduct a risk assessment and proactively test their products to protect patients and ensure that effective measures are taken to prevent the presence of nitrosamine impurities in human medicines.
Pharma manufacturers have limited time to perform further confirmatory testing on the products identified to be at risk of N-nitrosamine formation or cross-contamination and take mitigation measures where risks are identified, starting with the highest risk products.
This workshop will explore relevant aspects of root cause analysis and risk assessment with respect to potential Nitrosamine contamination in drug substances and drug products. You will hear what you need to know about the required risk assessments for medicinal products containing chemically synthesized APIs and how you can meet the international nitrosamine detection regulatory requirements. Few other learnings are:
- Introduction: General information and current regulatory updates
- Gaps in quality control and regulatory oversight that led to the contamination
- Expectations of regulatory authorities with respect to Nitrosamines
- Control and risk assessment strategies for early detection and prevention of Nitrosamines
- Implications for risk assessments
- Root cause analysis and latest analytical techniques for Nitrosamine identification
- Latest industry updates and case studies on Nitrosamine impurities"