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EMEA: Questions/answers on Endotoxin Testing and Sterility Testing at the end of shelf-life

22.05.2009
Is endotoxin testing considered essential at the end of shelf life to confirm parenterals to be pyrogen-free? Is sterility testing considered essential at the end of shelf life to confirm parenterals to be sterile?
The source of the news: http://www.emea.europa.eu/Inspections/qwp/list.htm#endotoxin