Nitrosamines Impurities Management

This webinar is designed to educate and train pharmaceutical manufacturing and quality control personnel on the identification, mitigation, and prevention of nitrosamine impurities. This session aligns with FDA Nitrosamine Drug Substance-Related Impurities (NDSRI) requirements and other global regulatory guidelines.

The webinar will begin with an introduction to nitrosamines, covering their chemical structure, formation mechanisms, and associated risks. An overview of the FDA's guidance on nitrosamine impurities in drugs will set the stage for a deeper dive into regulatory requirements. Participants will receive an in-depth review of FDA NDSRI guidance, including thresholds, testing requirements, and reporting obligations, as well as familiarize themselves with other global regulatory expectations.

Risk assessment training will focus on identifying potential sources of nitrosamine contamination in manufacturing processes, raw materials, and finished products. Participants will learn methods for evaluating the risk of nitrosamine formation and exposure. The session will also provide hands-on training on analytical techniques, such as LC-MS/MS and GC-MS, for detecting and quantifying nitrosamine impurities. Emphasis will be placed on interpreting analytical results and determining acceptable levels of nitrosamines.

Manufacturing controls to prevent nitrosamine formation will be detailed, including selecting raw materials with low nitrosamine potential, optimizing processes to minimize formation conditions, and establishing cleaning procedures to prevent cross-contamination. Supply chain management will be addressed, guiding participants on assessing and monitoring suppliers for compliance with nitrosamine-related requirements.

Quality control measures to monitor and verify nitrosamine levels in finished products, along with procedures for investigating deviations and documenting results, will be discussed. Change management education will cover procedures for managing changes that could impact nitrosamine risk, and the importance of continual improvement in nitrosamine risk management will be emphasized.

Areas Covered in the Session :

• Introduction to Nitrosamines:
  • Understanding the chemical structure, formation mechanisms, and potential risks associated with nitrosamines and formation of nitrosamines
  • Overview of FDA's guidance on nitrosamine impurities in drugs.
• Regulatory Requirements:
  • In-depth review of FDA NDSRI guidance, including thresholds, testing requirements, and reporting obligations.
  • Familiarization with other global regulatory guidelines and expectations regarding nitrosamine impurities.
• Risk Assessment:
  • Training on conducting risk assessments to identify potential sources of nitrosamine contamination in manufacturing processes, raw materials, and finished products.
  • Methods for evaluating the risk of nitrosamine formation and exposure.
• Analytical Techniques:
  • Hands-on training on analytical methods (e.g., LC-MS/MS, GC-MS) for detecting and quantifying nitrosamine impurities in pharmaceutical products.
  • Interpretation of analytical results and determination of acceptable levels of nitrosamines.
• Manufacturing Controls:
  • Detailed instruction on implementing appropriate manufacturing controls to prevent nitrosamine formation, such as:
    1. Selection of raw materials and excipients with low nitrosamine potential.
    2. Optimization of manufacturing processes to minimize conditions favorable for nitrosamine formation (e.g., avoiding nitrosating agents, controlling reaction conditions).
    3. Establishment of cleaning procedures to prevent cross-contamination.
  • Training on equipment maintenance and calibration to ensure process integrity.
• Supply Chain Management:
  • Guidance on assessing and monitoring suppliers for compliance with nitrosamine-related requirements.
  • Establishment of procedures for reviewing and approving suppliers based on their nitrosamine risk profiles.
  • Collaboration with suppliers to ensure transparency and traceability of raw materials.
• Quality Control and Assurance:
  • Training on implementing robust quality control measures to monitor and verify nitrosamine levels in finished products.
  • Procedures for investigating and addressing deviations from acceptable nitrosamine limits.
  • Documentation and reporting requirements for nitrosamine testing and results.
• Change Management:
  • Education on procedures for managing changes in manufacturing processes, formulations, or suppliers that could impact nitrosamine risk.
  • Implementation of risk-based assessments and controls for changes to minimize the potential for nitrosamine contamination.
• Monitoring & Continual Improvement:
  • Encouragement of a culture of continuous improvement regarding nitrosamine risk management.
  • Training on conducting periodic reviews and updates to nitrosamine control strategies based on emerging knowledge and regulatory developments.

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Research & Development Departments
• Supply Chain Management Departments
• Compliance Departments
• Analytical Chemists
• Production Departments
• Process Engineers
• This webinar is ideal for professionals in these departments and industries who are involved in the identification, mitigation, and prevention of nitrosamine impurities in pharmaceutical products. By attending, you will enhance your understanding of nitrosamine risk management and ensure compliance with FDA and global regulatory requirements.

Course Director: G. SUNDAR

G. Sundar is a quality practitioner with vast 35 years’ experience in the field of Quality Assurance, Quality Control, Bioequivalence and Pharmaceutical Regulations. His quality management experience covers the implementation of Quality tools in bulk drugs, formulation companies and CRO. He is an expert in Total Quality Systems as per GLP, GDP and as per EMEA, USFDA, MHRA and MCC, TGA, ANVISA, Japan guidelines. He has conducted more than 200 GMP/GLP audits including Q10 & Q11 implementation, 50 Formulation Contract Manufacturing Units (all types of formulations), 10 Contract Research and Analytical laboratories, 10 Clinical research CROs. He has also conducted 1000 plus trainings Asia, US, EU, Middle East and South-East Asia. Mr. Sundar Ganesan is the Director and Senior Consultant at PharmQA Compliance Services.