Industry Training Workshop on (i) Product Defect Reporting and Recall Procedures, and (ii) Management of Nitrosamine Impurities in Therapeutic Products

The Vigilance and Compliance Branch (VCB) conducted an online industry training workshop on 29 and 30 October 2024. The objectives of the workshop were to:

1. Provide a comprehensive overview of the procedures and requirements of product defect reporting and recall for therapeutic products and cells, tissue and gene therapy products; and

2. Clarify HSA’s current approach, recommendations, and regulatory requirements for managing nitrosamine impurities in therapeutic products.

We appreciate industry stakeholders’ active participation during the Q&A sessions. We have made the following resources available on the HSA website:

Day 1 (29 October 2024) – Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products

• Presentation slides - Product Defect Reporting and Recall Procedures [PDF, 2 MB]

• Workshop recording - Product Defect Reporting and Recall Procedures

• Supplementary document addressing questions raised during the Q&A session of the workshop- Product Defect Reporting and Recall Procedures [PDF, 86 KB]

Day 2 (30 October 2024) – Management of Nitrosamine Impurities in Therapeutic Products

• Presentation slides - Management of Nitrosamine Impurities [PDF, 4.3 MB]

• Workshop recording - Management of Nitrosamine Impurities

• Supplementary document addressing questions raised during the Q&A session of the workshop - Management of Nitrosamine Impurities [PDF, 67 KB]