The guidance recommends a three-step process API and drug product manufacturers should follow to detect, prevent and mitigate nitrosamine impurities in pharmaceutical products.
The first step is assessing the risk of nitrosamine impurities in APIs, marketed products, and products under approved and pending applications. If an API or drug product is determined to be at risk, manufacturers should perform the second step: conducting confirmatory testing for the presence of nitrosamine impurities.
To ensure the safety of the U.S. drug supply, the guidance recommends that manufacturers should conclude the first step, the risk assessment of approved or marketed products, within 6 months of guidance publication. Through today’s revision, FDA extends the recommended timeframe for completion of risk assessments to March 31, 2021. Manufacturers do not need to submit risk assessment documents to the agency, but they should retain these documents so they are available if requested.