This BioPhorum peer reviewed paper proposes to unify current industry approaches with a single core standard of test methods and criteria necessary for GMP manufacturing. A common testing standard would have multiple benefits including consistency across suppliers, protection of supplier intellectual property, and facilitation of drug development.
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An industry reflection on the application of the Russian Pharmacopeia to the registration of biologics
Sep 2021 | Deliverable, Drug Substance, POI - Regulatory, Post Approval Strategies, Publication, Regulatory
In this paper, a BioPhorum member team of experts in biologics and vaccines have summarized the current challenges linked to the registration of global products in Russian Federation. This paper describes some of the challenges faced by the industry in relation to current pharmacopoeial requirements for biologics and vaccines and presents a framework of options and activities that would lead to greater alignment with the ICH and the expectations of other regulatory agencies.