In April, the World Health Organization (WHO) became the latest health authority to release a draft guidance on Current Good Manufacturing Practices (CGMP) considerations for the prevention and management of nitrosamine contamination in pharmaceutical products.
This year has seen a flurry of activity by the U.S. Food and Drug Administration surrounding ophthalmic products.
A recently completed pilot project in Vietnam to validate and implement monitoring procedures for nitrosamine impurities in medicines is an inspiring example of how international collaboration and cooperation can help ensure medicines quality across geographies and strengthen the supply chain.
The issue of addressing potential nitrosamine impurities in medicines has been the focus at events taking place around the globe in recent months and will continue to do so throughout 2023.
In the U.S. and around the world, quality standards developed by the U.S. Pharmacopeia (USP) support the availability of safe, quality medicines, regulatory efficiencies, and a strong global medicine supply chain.
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