Certification to the Antibiotic Manufacturing Standard will be a clear sign that manufacturers in the global antibiotic supply chain are taking necessary steps to ensure antibiotics are made responsibly, helping to minimize the risk of releasing antibiotic waste emissions into the environment.This follows the publication of the globally applicable industry standard in June 2022. The standard was facilitated by BSI for the AMR Industry Alliance, an organization made up of over 100 companies and associations from across the life-sciences industry with the shared goal of providing sustainable solutions to curb AMR.The new certification, developed by BSI to support the Standard, will offer independent third-party verification that waste streams containing antibiotic active pharmaceutical ingredient (API) and drug products are appropriately controlled during manufacturing by pharmaceutical companies.
This certification program will involve initial evaluation against the requirements of the standard and annual surveillance to verify ongoing maintenance of the appropriate controls over time. After the initial launch, all antibiotic manufacturers globally will be eligible to seek certification by BSI.
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