CGA PS-66 PDF

The discovery of nitrosamine impurity in one type of drug product in 2018, led the United States Food and Drug Administration (FDA), Health Canada, and other international regulators to begin to investigate the presence of this contaminant in other drugs. With additional drug products being identified leading to recalls in 2019, the FDA and Health Canada required firms to establish plans to conduct risk analysis of their manufactured drug products and the active pharmaceutical ingredients they used for the presence of nitrosamines. If nitrosamines were found to be present, firms were required to ensure that levels did not exceed recommended acceptable intake limits. Medical gases are classified as drugs in both the United States and Canada, therefore CGA evaluated the production inputs and outputs of common medical gases. CGA members have also received inquiries regarding nitrosamine contamination of gases used by pharmaceutical firms in the manufacture of their products. This position statement and the associated technical report reflect the results of the evaluation CGA performed and is consistent with CGA's March 26, 2020 letter to Health Canada in response to DEL Bulletin No 57 regarding nitrosamines.