hyperopia, thx for the clarification, I am quite familiar with the area of extractables/leachables from pharma packaging components such as rubber stoppers as well as processing such as transfer tubing but did not perceive that to be the focus of the question.
Since this is not a new area for pharma compliance and control activities I would be shocked if anyone involved in Development and Quality were not acutely aware of the requirements here and did not ensure proper leachables testing during early development.
Maybe I am still missing the question and apologize if so but this question would just be one of many boxes to check during product/process development to qualify the equipment that I am sure was done. If suppliers were changed for product contact components this is a primary question to answer up front before the change is executed. Most component suppliers will also either perform the testing for the customer or have an arrangement with a qualified lab to simplify the testing for the customer.
GLTA
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