According to the IPEC, the issue for the paper is that the presence of N-nitrosamines in drug products continues to be a global concern. Excipients are considered as a potential risk factor during the drug product risk assessment. The focus of this position paper is to expand on the potential contribution excipients may or may not have on the formation of nitrosamines in final drug products. The presence of nitrites and vulnerable amines in excipients are also considered.
Even though excipient manufacturers are under no specific regulatory requirement to provide risk assessments on nitrosamines to regulatory agencies, the IPEC considers a risk-based cooperation between the pharmaceutical manufacturer and an excipient supplier appropriate. It is necessarily in the interest of an excipient manufacturer to supply safe excipients. Water in various qualities, raw materials, and excipient processing conditions could be sources of nitrites and nitrates. Excipient suppliers should carefully evaluate the potential risk related to their excipients. This will assist medicinal product manufacturers to fulfill their regulatory obligation which is to conduct risk assessments for their drug products.
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