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Autor:
Magnus Stering, Sean Tomlinson, Brian Thome, Mandar Dixit, Stephanie S Ferrante, Leesa McBurnie, Dawood Dassu, Jeff Gaerke, Brian Joseph, Scott Mills, Carl Weitzmann
Publikováno v:
PDA journal of pharmaceutical science and technology. 74(5)
Eudralex volume 4, Annex 1, the European Union Good Manufacturing Practice for sterile products, requires that “The integrity of the sterilised filter should be verified before use” (1). Implicit in this requirement for a PUPSIT is the rationale