On 19 May 2009 EMEA published 2 new Question and Answers (Q/As) on endotoxin testing and sterility testing at the end of the shelf-life. These Q/As aim at clarifying whether endotoxin/sterility testing is necessary at the end of shelf-life and whether sterility testing can be replaced by testing of the container closure integrity.
Is endotoxin testing considered essential at the end of shelf life to confirm parenterals to be pyrogen-free?
Answer: Endotoxin testing is not requested at the end of shelf-life taking into account that it is not considered a stability indicating parameter. The shelf life specification should be completed with a footnote stating that endotoxins are not tested during stability studies.
Is sterility testing considered essential at the end of shelf life to confirm parenterals to be sterile?
Answer: Sterility is part of the shelf-life specification. Sterility testing should be performed at least at the end of shelf life but it can be replaced by testing of the container closure integrity. Depending on the nature of the container, intermittent integrity testing might be envisaged, independent of whether the sterility testing is replaced or not.